​Vitex Rotundifolia (Roundleaf Chaste Tree)

Vitex Rotundifolia (Roundleaf Chaste Tree)

Product Name: Витекс круглолистный, Vitex rotundifolia, Rundblättriger Mönchspfeffer, Sauzgatillo de hoja redonda, Gattilier à feuilles rondes, التـوت الفيتـيكس دائـري الأوراق, พันงั่วใบกลม, Yumshoq bargli viteks, Жалпак жалбырактуу витекс, Dairəvi yarpaqlı viteks, Витекс баргашакл, Apvalialapis viteksas, Apaļlapu vitekss, Вітекс круглолистий, Dairəvi yarpaqlı viteks, וִיטֶקְס עָגוֹל־עָלִים

Synonyms: витекс приморский, круглолистный витекс, витекс песчаный, песчаный монаховник, Vitex trifolia var. simplicifolia, Roundleaf chaste tree, Beach vitex, Küsten-Mönchspfeffer, Vitex de playa, Gattilier des plages, Vitex البحري, พันงั่วทะเล

Used Parts: leaves, flowers, fruits, seeds, roots, bark, stems, shoots, leaves.

Main Indications for Use of Vitex rotundifolia: Dysmenorrhea, premenstrual syndrome, menopausal syndrome, mastalgia, adnexal inflammation, chronic salpingo-oophoritis, benign mastopathy, fibrocystic mastopathy, neurocirculatory dystonia, migraine, acne, seborrheic dermatitis, chronic fatigue, irritable bowel syndrome.

Use of Vitex rotundifolia in Mixtures and Complexes: Bacterial vulvovaginitis, chronic endometritis, hormonally induced headaches, climacteric neurosis, panic disorders in premenopause, hormonal infertility, endometrial hyperplasia, polycystic ovary syndrome, premenstrual dysphoric disorder, chronic pyelonephritis, spastic colitis.

Pharmacological Properties of Vitex rotundifolia: estrogen-like, progestogenic, analgesic, anxiolytic, adaptogenic, antidepressant, anti-inflammatory, antimicrobial, antiandrogenic, spasmolytic, hepatoprotective, immunomodulating, antioxidant, photoprotective, anti-acne, neuroprotective, antiproliferative, sedative, antihistamine.

Dosage of Pharmaceutical Forms — Vitex rotundifolia

Powder — Vitex rotundifolia

Indications (Powder): Premenstrual syndrome, dysmenorrhea, mastalgia, fibrocystic mastopathy, climacteric syndrome, benign endometrial hyperplasia, chronic salpingo-oophoritis, hormone-dependent acne.

Standard Dosage (Powder): 1 gram of powder of dry leaves or fruits once in the morning, on an empty stomach, 30 minutes before meals, with warm water. Course of intake — 30 days.

Enhanced Dosage (Powder): 2 grams of powder twice a day — in the morning on an empty stomach and in the evening 1 hour before bedtime — for severe dysmenorrhea, pronounced climacteric syndrome, recurrent mastalgia, endometrial hyperplasia with prolonged menstruation.

Maximum Dosage (Powder): 3 grams of powder three times a day (total 9 grams per day) is permissible only under medical supervision for no more than 7 days for severe forms of premenstrual dysphoric disorder and hormone-dependent acne accompanied by inflammation and seborrhea.

Preventive Dosage (Powder): 0.5 grams of powder once in the morning, in a 21-day course with a 7-day break. Recommended for neurocirculatory dystonia, menstrual cycle instability in pubertal girls, initial manifestations of menopause, and chronic fatigue syndrome.

Pediatric Dosage (Powder): Use is permitted in girls over 12 years of age with a body weight of at least 40 kilograms — no more than 0.5 grams of powder once in the morning, no more than a 15-day course under specialist supervision. Not used in boys.

Contraindications (Powder): Individual intolerance, pregnancy, lactation, pronounced arterial hypotension, taking drugs with dopaminergic effect (dopamine antagonists). Scientific data on contraindications in children under 12 years, during pregnancy, and lactation have not been registered.

Side Effects (Powder): In case of overdose, the following side effects have been recorded: headache, irritability, nausea, diarrhea, skin rash, temporary increase in mastalgia symptoms.

Adjustment for Patient Body Weight: For body weight less than 60 kg, the dose should be reduced by 25%. For body weight over 80 kg, upward dose correction of 15–20% is possible, especially with pronounced symptoms of hormonal imbalance.

Preparation Method (Powder): Dried leaves and mature fruits of the plant are ground to a homogeneous powder with a particle size of no more than 0.3 millimeters. To prepare 100 grams of powder, the following is used: 70 grams of dry leaves, 30 grams of dry fruits. The raw material is dried at a temperature not exceeding 45 degrees Celsius in the shade, without access to direct light. Grinding is carried out on a ceramic mortar or a low-speed mill. The finished powder is packaged in airtight glass jars.

Storage Conditions and Shelf Life (Powder): Store in a tightly closed glass container, in a dry, dark place at a temperature of 5 to 25 degrees Celsius, away from sources of electromagnetic radiation. Shelf life — up to 12 months. After opening the package, use within 60 days.

Dry Extract — Vitex rotundifolia

Indications (Dry Extract): Premenstrual syndrome, dysmenorrhea, mastalgia, fibrocystic mastopathy, chronic salpingo-oophoritis, hormone-dependent acne, climacteric syndrome, benign endometrial hyperplasia, chronic endometritis.

Standard Dosage (Dry Extract): 100 milligrams of dry standardized extract once a day in the morning on an empty stomach, in a 30-day course. Dissolution in 100 milliliters of warm water is permissible.

Enhanced Dosage (Dry Extract): 200 milligrams of dry extract once a day, in the morning on an empty stomach, for pronounced forms of premenstrual syndrome, chronic endometritis, high-intensity mastalgia, and exacerbation of climacteric syndrome symptoms.

Maximum Dosage (Dry Extract): 300 milligrams of dry extract once in the morning for 5 days is possible under medical supervision for severe dysmenorrhea with heavy menstrual bleeding, pronounced premenstrual dysphoric disorder, and concomitant anemia.

Preventive Dosage (Dry Extract): 50 milligrams of dry extract once a day, in the morning on an empty stomach. Course of intake — 21 days with a 7-day break. Used for initial manifestations of hormonal dysregulation, in women over 40 years with menopausal precursors, chronic fatigue syndrome, and mild mastalgia.

Pediatric Dosage (Dry Extract): Use is permitted in girls over 12 years of age with a body weight of at least 40 kilograms. Permissible dose — no more than 50 milligrams of dry extract once a day in the morning, for no more than 15 days. Use is possible only as prescribed by a physician.

Contraindications (Dry Extract): Individual intolerance, pregnancy, lactation, severe forms of arterial hypotension, taking dopamine antagonists, pituitary tumors. Scientific data on contraindications during pregnancy, lactation, and under 12 years have not been registered.

Side Effects (Dry Extract): Registered: nausea, headache, weakness, diarrhea, skin rash, irritability, increased pain in mastopathy in the first days of intake.

Adjustment for Patient Body Weight: For body weight less than 60 kg, the dosage is reduced by 25%. For body weight over 80 kg, the dosage may be increased by 15% with insufficient clinical effectiveness.

Preparation Method (Dry Extract): To prepare 100 grams of dry extract, 600 grams of ground dry raw material (leaves and fruits in a 2:1 ratio) are used. Extraction is carried out in a water-alcohol medium (40% ethanol) for 8 hours at a temperature of 60 degrees Celsius. The resulting infusion is filtered, evaporated in a water bath to a volume of 100 milliliters, then dried by spray drying to obtain a dry extract with a residual moisture content of no more than 5%. The finished extract is packaged in an airtight container.

Storage Conditions and Shelf Life (Dry Extract): Store in an airtight opaque container at a temperature of 5 to 25 degrees Celsius, in a dry place, protected from direct light and sources of electromagnetic radiation. Shelf life — 18 months. After opening, use within 60 days.

Alcohol-Based Tincture — Vitex rotundifolia

Indications (Tincture): Premenstrual syndrome, dysmenorrhea, mastalgia, climacteric syndrome, chronic salpingo-oophoritis, benign mastopathy, neurocirculatory dystonia, fibrocystic mastopathy, hormone-dependent acne.

Standard Dosage (Tincture): 20 drops of alcohol tincture (equivalent to 1 milliliter) once a day in the morning on an empty stomach, 30 minutes before meals. Course — 30 days.

Enhanced Dosage (Tincture): 20 drops twice a day — in the morning and at 4:00 PM — for pronounced manifestations of premenstrual syndrome, high-intensity mastalgia, hormone-dependent acne with inflammation, and exacerbation of climacteric syndrome symptoms.

Maximum Dosage (Tincture): 30 drops three times a day (total 90 drops/4.5 ml per day) is permissible for no more than 5 days for pronounced clinical manifestations of premenstrual dysphoric disorder, chronic salpingo-oophoritis, and neurocirculatory dystonia with panic episodes.

Preventive Dosage (Tincture): 15 drops once a day in the morning, in a 21-day course with a 7-day break. Recommended for women over 35 years of age with menstrual cycle instability, psycho-emotional lability, premenopausal symptoms, and autonomic dysfunction.

Pediatric Dosage (Tincture): Use of alcohol tincture is contraindicated in children and adolescents under 14 years. Over 14 years — only as prescribed by a physician, no more than 10 drops per day with a body weight above 50 kilograms.

Contraindications (Tincture): Pregnancy, lactation, childhood under 14 years, alcoholism, liver diseases, epilepsy, taking dopamine antagonists. Data on complete safety of use in adolescence and during lactation have not been registered.

Side Effects (Tincture): Overdose may cause dizziness, tachycardia, irritability, nausea, feeling of heat, rash, and increased breast pain.

Adjustment for Patient Body Weight: For body weight less than 60 kg, the dosage should be reduced to 15 drops. For weight above 80 kg — an increase to 25 drops is possible, especially in the presence of pronounced clinical symptoms.

Preparation Method (Tincture): To prepare 100 milliliters of alcohol tincture, the following is required: 25 grams of dry leaves and fruits (in a 2:1 ratio), 75 milliliters of 70% ethyl alcohol (pharmaceutical grade). The raw material is poured with alcohol, tightly closed, and infused in a glass container at room temperature (18–25 degrees Celsius) in a dark place for 10 days, shaken daily. Upon completion, it is strained through two layers of gauze and stored in a dark pharmacy bottle.

Storage Conditions and Shelf Life (Tincture): Store in a tightly closed dark glass container at a temperature of 5 to 25 degrees Celsius, away from light and electromagnetic sources. Shelf life — 24 months. After opening, use within 90 days.

Oil Infusion — Vitex rotundifolia

Indications (Oil Infusion): Hormone-dependent acne, fibrocystic mastopathy, mastalgia, seborrheic dermatitis, atopic dermatitis, itching of the external genitalia, premenstrual breast tension, menopausal skin dryness.

Standard Dosage (Oil Infusion): Local application in a thin layer 1–2 times a day on the affected area. For facial application — 3–4 drops, on the breast area — up to 5 drops, gently rubbing until completely absorbed. Course — 14–21 days.

Enhanced Dosage (Oil Infusion): Application 3 times a day for pronounced itching, exacerbation of dermatitis, breast pain, and menopausal estrogen deficiency with pronounced skin dryness. A night compress on the skin (up to 20 drops) is permissible for mastopathy.

Maximum Dosage (Oil Infusion): Application up to 4 times a day locally is permissible, as well as use as oil tampons (up to 1 ml of oil per tampon) for atrophy of the external genital mucosa — no more than 5 days in a row under medical supervision.

Preventive Dosage (Oil Infusion): Once a day — in the evening — apply to areas of increased skin sensitivity (chest, neck, face) for women over 40 years with initial menopausal changes, as well as in the presence of mastopathy in remission. Course — 10 days per month.

Pediatric Dosage (Oil Infusion): Use is permitted from 10 years of age for seborrheic dermatitis and mild acne. No more than 1–2 drops on the face or locally on inflamed skin areas once a day. If necessary — course no more than 7 days.

Contraindications (Oil Infusion): Individual intolerance. Data on contraindications during pregnancy, lactation, and in children under 10 years have not been scientifically registered. Avoid contact with eyes and mucous membranes without medical consultation.

Side Effects (Oil Infusion): In case of overdose or increased skin sensitivity, redness, burning, contact dermatitis, increased itching and peeling are possible.

Adjustment for Patient Body Weight: Not required for external use. When used in the form of compresses and oil applications on the chest — with a body weight over 80 kg, a dose increase of up to 30% is permissible due to a larger application area.

Preparation Method (Oil Infusion): To prepare 100 milliliters of oil infusion: 25 grams of dry leaves, 75 milliliters of cold-pressed coconut oil. The raw material is ground, poured with warm oil (temperature 40 degrees Celsius), kept in a water bath for 3 hours at a stable temperature of 40–45 degrees Celsius, then cooled and infused in a dark place for 5 days. After infusion, it is filtered through fabric or gauze. The finished infusion is packaged in dark glass vials.

Storage Conditions and Shelf Life (Oil Infusion): Store in a dark place at a temperature of 10 to 25 degrees Celsius, in a tightly closed glass bottle. Avoid exposure to light and heat. Shelf life — up to 6 months. After opening, use within 45 days.

Vaginal Suppository — Vitex rotundifolia

Indications (Vaginal Suppository): Chronic endometritis, benign endometrial hyperplasia, premenstrual dysphoric disorder, hormone-dependent vulvovaginitis, fibrocystic mastopathy, climacteric syndrome with vaginal atrophy, chronic salpingo-oophoritis.

Standard Dosage (Vaginal Suppository): 1 suppository (containing 100 milligrams of dry extract) at night, vaginally, in a course of 10–12 days. It is recommended to use outside of menstruation.

Enhanced Dosage (Vaginal Suppository): 1 suppository 2 times a day (morning and at night) for pronounced manifestations of chronic endometritis, endometrial hyperplasia, and vulvovaginitis of hormone-dependent origin. Course no more than 7 days.

Maximum Dosage (Vaginal Suppository): Up to 3 suppositories per day is possible for severe forms of chronic salpingo-oophoritis or premenopausal endometrial hyperplasia, but only under the supervision of a gynecologist and for no more than 5 days in a row.

Preventive Dosage (Vaginal Suppository): 1 suppository every other day for 14 days (total 7 doses) — for perimenopausal women with mild menopausal symptoms, as well as in the post-treatment period for mastopathy and endometritis in remission.

Pediatric Dosage (Vaginal Suppository): Not used in girls under 18 years. Scientific data on safety of use in adolescent girls are absent.

Contraindications (Vaginal Suppository): Pregnancy, acute inflammatory processes of the vagina, vaginal bleeding of unclear etiology. Scientific data on safety of use during lactation are absent. Contraindicated in allergy to cocoa butter contained in the base.

Side Effects (Vaginal Suppository): In case of overdose, local irritation of the vaginal mucosa, burning sensation, increased discharge, and headache are possible.

Adjustment for Patient Body Weight: Correction is not required for body weight less than 60 or more than 80 kilograms, as the drug acts locally.

Preparation Method (Vaginal Suppository): For 10 suppositories of 2 grams each, the following is required: 10 grams of cocoa butter, 1 gram of beeswax, 1 gram of dry extract of Vitex rotundifolia. Cocoa butter and wax are melted in a water bath at a temperature of 40–45 degrees Celsius. After dissolution, the powder of dry extract is introduced and the mass is thoroughly mixed. The mixture is poured into suppository molds and cooled at a temperature of 8–10 degrees Celsius until completely solidified. Stored in the original packaging.

Storage Conditions and Shelf Life (Vaginal Suppository): Store in a cool place at a temperature of 5 to 15 degrees Celsius, in individual film or a blister. Avoid exposure to direct light and heat. Shelf life — up to 6 months. After opening the blister, use within 7 days.

Rectal Suppository — Vitex rotundifolia

Indications (Rectal Suppository): Neurocirculatory dystonia, climacteric syndrome, chronic salpingo-oophoritis, fibrocystic mastopathy, benign endometrial hyperplasia, premenstrual dysphoric disorder, hormone-dependent migraine, chronic endometritis.

Standard Dosage (Rectal Suppository): 1 suppository (containing 100 milligrams of dry extract) at night, rectally, after bowel evacuation. Course — 10 days.

Enhanced Dosage (Rectal Suppository): 1 suppository 2 times a day — morning and evening — for pronounced manifestations of dysphoric disorder, hormone-dependent migraine, exacerbations of chronic endometritis or mastopathy. Course — no more than 7 days.

Maximum Dosage (Rectal Suppository): Up to 3 suppositories per day is possible for resistant forms of neurocirculatory dystonia, chronic salpingo-oophoritis, or severe menopausal manifestations. Course — no more than 5 days, under specialist supervision.

Preventive Dosage (Rectal Suppository): 1 suppository every other day, rectally, in a 14-day course (7 suppositories) — for a tendency to hormone-dependent headaches, in the post-treatment period after normalization of hormonal levels, and in perimenopause.

Pediatric Dosage (Rectal Suppository): Not used in children and adolescents under 18 years. Data on safety of use in persons under 18 years in rectal form have not been registered.

Contraindications (Rectal Suppository): Pregnancy, inflammation of the rectum, hemorrhoidal bleeding, anal fissures. Scientific data on safety of use during lactation are absent. Allergy to cocoa butter or beeswax.

Side Effects (Rectal Suppository): Rarely, irritation of the rectal mucosa, mild diarrhea, spastic pain in the lower abdomen, and headache are possible.

Adjustment for Patient Body Weight: Dose adjustment by body weight is not required, as the form is intended for local and systemic absorption in dosed amounts.

Preparation Method (Rectal Suppository): To prepare 10 suppositories of 2 grams each, the following is required: 10 grams of cocoa butter, 1 gram of beeswax, 1 gram of dry extract of Vitex rotundifolia. Cocoa butter and beeswax are melted in a water bath at a temperature of 40–45 degrees Celsius, the extract is added, and the mixture is thoroughly mixed until completely homogeneous. The mass is poured into rectal suppository molds and cooled at a temperature of 8–10 degrees Celsius until solidified.

Storage Conditions and Shelf Life (Rectal Suppository): Store in a cool, dry place at a temperature of 5 to 15 degrees Celsius, in individual protective packaging, protected from light and heat. Shelf life — up to 6 months. After opening the package, use within 5 days.

Nasal Drops — Vitex rotundifolia

Indications (Nasal Drops): Allergic rhinitis, vasomotor rhinitis, hormone-dependent nasal mucosal edema, postmenopausal syndrome with nasal breathing impairment, chronic sinusitis, premenstrual nasal congestion.

Standard Dosage (Nasal Drops): 2 drops in each nostril 2 times a day — morning and evening. Course — 7 days. Before use, it is recommended to cleanse the nasal passages.

Enhanced Dosage (Nasal Drops): 3 drops in each nostril 3 times a day for pronounced hormone-dependent edema, difficulty breathing, and exacerbation of chronic vasomotor rhinitis. Course no more than 5 days.

Maximum Dosage (Nasal Drops): Up to 4 drops in each nostril up to 4 times a day is permissible in acute phases of allergic rhinitis or vasomotor disorder with pronounced nasal breathing impairment — no more than 3 days in a row.

Preventive Dosage (Nasal Drops): 1 drop in each nostril once a day, in the evening, in a 10-day course. Recommended for seasonal premenstrual nasal congestion, chronic mucosal dryness in perimenopausal women, and initial manifestations of vasomotor disorders.

Pediatric Dosage (Nasal Drops): Permitted from 10 years of age. No more than 1 drop in each nostril once a day. Use is possible for mild allergic rhinitis. Course — no more than 5 days. Use in boys is not recommended.

Contraindications (Nasal Drops): Pregnancy, childhood under 10 years, acute purulent sinusitis, mechanical damage to the nasal mucosa. Reliable scientific data on safety of use during pregnancy and lactation are absent.

Side Effects (Nasal Drops): In some cases, mucosal irritation, burning in the nose, sneezing, short-term increased congestion, and headache are possible.

Adjustment for Patient Body Weight: Dose adjustment is not required. The volume of administration is limited by the capacity of the nasal mucosa.

Preparation Method (Nasal Drops): For 100 milliliters of nasal drops, the following is used: 5 grams of dry extract of Vitex rotundifolia, 10 milliliters of vegetable glycerin, 85 milliliters of physiological sodium chloride solution (0.9%). The extract is dissolved in a pre-heated to 40 degrees solution of salt and glycerin. The mixture is thoroughly filtered through a membrane filter. Poured into sterile dark glass dropper bottles with a pipette.

Storage Conditions and Shelf Life (Nasal Drops): Store at a temperature of 4 to 10 degrees Celsius, in a tightly closed dark glass container, protected from light. Shelf life — 30 days. After opening, use within 7 days.

Ear Drops — Vitex rotundifolia

Indications (Ear Drops): Inflammation of the external ear, allergic otitis, hormone-dependent itching of the auditory canal, chronic external otitis, seborrheic dermatitis of the auricle, menopausal discomfort in the external auditory canal.

Standard Dosage (Ear Drops): 2 drops in each auditory canal 2 times a day — morning and evening. After instillation, it is necessary to maintain a head tilt position for 3–5 minutes. Course — 5–7 days.

Enhanced Dosage (Ear Drops): 3 drops in each auditory canal 3 times a day for pronounced itching, peeling, hyperemia, or the presence of serous discharge. Course — 5 days; additional treatment of the external auricle with a cotton swab with drops is permissible.

Maximum Dosage (Ear Drops): Up to 4 drops in each auditory canal up to 4 times a day for exacerbation of chronic allergic or hormone-dependent otitis. Course no more than 3 days under specialist supervision.

Preventive Dosage (Ear Drops): 1 drop in each auditory canal once a day before bedtime for 5 days. Used for a tendency to dermatitis of the external ear, in climacteric age, and with prolonged use of hearing aids.

Pediatric Dosage (Ear Drops): Use is permitted from 12 years of age, 1 drop in each ear once a day for mild inflammation or itching. Course — up to 3 days. Use in children under 12 years is not recommended due to the lack of safety data.

Contraindications (Ear Drops): Perforation of the tympanic membrane, acute purulent otitis, trauma of the external auditory canal, age under 12 years. Scientific data on safety of use during pregnancy and lactation are absent.

Side Effects (Ear Drops): Rarely, itching, a feeling of ear congestion, hyperemia, and reversible irritation of the auditory canal skin are observed.

Adjustment for Patient Body Weight: Dose adjustment is not required. The volume of administration is limited by the anatomical structure of the auditory canal.

Preparation Method (Ear Drops): To prepare 100 milliliters of drops, the following is required: 5 grams of dry extract of Vitex rotundifolia, 10 grams of glycerin, 85 milliliters of coconut oil (pre-refined and liquid at 25 degrees). The extract is dissolved in warm oil with the addition of glycerin at a temperature of 35–40 degrees Celsius, thoroughly mixed. The mixture is strained through fine gauze, packaged in dark glass dropper bottles with a dispenser.

Storage Conditions and Shelf Life (Ear Drops): Store in a dark, cool place at a temperature of 5 to 15 degrees Celsius. After opening, use within 14 days. Do not allow water to enter the bottle. Shelf life of an unopened bottle — up to 3 months.

Liquid Cosmetic Extract — Vitex rotundifolia

Indications (Liquid Cosmetic Extract): Hormone-dependent acne, seborrheic dermatitis, age-related hyperpigmentation, decreased skin elasticity, menopausal epidermal thinning, inflammatory elements on the facial skin, post-acne.

Standard Dosage (Liquid Cosmetic Extract): Apply 3–5 drops pointwise or in a thin layer to cleansed facial skin once a day, in the evening, in a course of up to 21 days. Can be used as a component in creams, serums, and masks.

Enhanced Dosage (Liquid Cosmetic Extract): Apply 5–7 drops 2 times a day — morning and evening — for pronounced acne, inflamed seborrhea, decreased skin elasticity in the perioral and periorbital areas. Recommended to combine with non-greasy moisturizers.

Maximum Dosage (Liquid Cosmetic Extract): Up to 10 drops 3 times a day is possible for resistant forms of hormone-dependent acne, persistent post-acne spots, and age-related skin atrophy. Course no more than 7 days. Only under the supervision of a dermatologist or cosmetologist.

Preventive Dosage (Liquid Cosmetic Extract): 2 drops once a day on the facial skin or areas of increased sensitivity in women over 35 years of age with dry skin, initial signs of aging, and loss of tone. Course — 10 days, repeat every 2 months.

Pediatric Dosage (Liquid Cosmetic Extract): Spot application of 1 drop on inflamed elements is permissible in adolescents over 12 years with mild acne. Apply once a day for no more than 7 days in a row.

Contraindications (Liquid Cosmetic Extract): Individual sensitivity, acute dermatoses, open ulcers and eczema. Safety of use during pregnancy and lactation has not been studied. Avoid contact with eyes.

Side Effects (Liquid Cosmetic Extract): A tingling sensation, redness, and peeling of the skin with individual sensitivity are possible. In case of overdose — reversible irritation and dryness.

Adjustment for Patient Body Weight: Not required. The cosmetic form is intended for external use and does not penetrate systemically.

Preparation Method (Liquid Cosmetic Extract): For 100 milliliters of extract: 10 grams of dry leaves and fruits (2:1), 30 milliliters of vegetable glycerin, 60 milliliters of purified water. The raw material is ground, poured with a mixture of water and glycerin, infused at a temperature of 35 degrees Celsius for 48 hours. Then filtered through fine-mesh fabric. The finished extract is packaged in sterile dropper bottles.

Storage Conditions and Shelf Life (Liquid Cosmetic Extract): Store at a temperature of 5 to 15 degrees Celsius, in a dark place, in an airtight package, shielded from sources of electromagnetic radiation. Shelf life — up to 3 months. After opening, use within 14 days.

Cream — Vitex rotundifolia

Indications (Cream): Hormone-dependent acne, seborrheic dermatitis, age-related dry skin, premenopausal loss of elasticity, post-acne, inflammatory skin elements, menopausal epidermal atrophy, localized hyperpigmentation.

Standard Dosage (Cream): Apply 0.5 grams (about the size of a pea) to cleansed facial skin once a day, preferably in the evening. Avoid the eye area. Course — 21 days.

Enhanced Dosage (Cream): Apply 0.5–1 gram of cream twice a day — morning and evening — on areas with pronounced inflammation, decreased elasticity, or increased oiliness. Use under non-comedogenic makeup is permissible.

Maximum Dosage (Cream): Up to 1.5 grams of cream 3 times a day for severe forms of acne, active seborrhea, post-acne infiltrates, deep wrinkles, and age-related skin hypotonia. Course no more than 7 days, under the supervision of a dermatologist.

Preventive Dosage (Cream): 0.3 grams of cream once a day in the evening, in a 10-day course. Used for the prevention of hormone-dependent skin inflammation, early aging, and skin hyperreactivity in women over 35 years.

Pediatric Dosage (Cream): Permitted from 12 years — pointwise, no more than 0.2 grams of cream (the size of a pinhead) once a day on individual inflammatory elements. Course — up to 5 days. Only in girls during puberty.

Contraindications (Cream): Individual intolerance to components. Acute weeping dermatoses. Open ulcerative lesions. Safety data for use during pregnancy and lactation are absent. Avoid application to mucous membranes.

Side Effects (Cream): A tingling sensation, short-term burning, contact skin irritation, peeling, and hyperemia are possible. In case of overdose — dryness and skin irritation.

Adjustment for Patient Body Weight: Not required. The volume of application is determined by the area of the lesion and skin type, not body weight.

Preparation Method (Cream): For 100 grams of cream, the following is required: 5 grams of dry extract of Vitex rotundifolia, 10 grams of coconut oil, 5 grams of jojoba oil, 10 grams of beeswax, 65 grams of distilled water, 5 grams of lecithin. The wax-oil phase (wax, oils) is melted at a temperature of 60 degrees Celsius. The aqueous phase is heated to 45 degrees and lecithin and extract are dissolved in it. Slowly combine both phases with continuous stirring, cool with stirring to room temperature. Pour into sterile frosted glass jars.

Storage Conditions and Shelf Life (Cream): Store in a dark, cool place at a temperature of 5 to 15 degrees Celsius. Avoid direct light, overheating, and contact with metals. Shelf life — 3 months. After opening, use within 30 days.

Ointment — Vitex rotundifolia

Indications (Ointment): Inflammatory skin elements, infiltrates in hormone-dependent acne, itching of the external genitalia, menopausal dermatitis, post-acne with hyperkeratosis, premenstrual skin sensitivity, localized neurodermatitis.

Standard Dosage (Ointment): Apply a thin layer (0.5 grams) to the affected skin areas once a day in the evening, without rubbing. Course of use — up to 10 days.

Enhanced Dosage (Ointment): Apply 2 times a day — morning and evening — for pronounced inflammation, itching, hyperkeratosis, or local edema. Application under a gauze bandage at night is permissible. Course — 7 days.

Maximum Dosage (Ointment): Up to 1.5 grams of ointment 3 times a day is possible for severe recurrences of neurodermatitis, persistent post-acne areas with inflammation or hyperpigmentation. Course — no more than 5 days.

Preventive Dosage (Ointment): 0.3 grams of ointment once a day — in the evening — applied to sensitive skin areas in women in the climacteric period or with a tendency to inflammation before menstruation. Course — 5–7 days per month.

Pediatric Dosage (Ointment): Use is permitted in girls over 10 years of age for acne and itching of the external genitalia. Apply no more than 0.2 grams once a day pointwise. Course — no more than 5 days. Use in boys is not recommended.

Contraindications (Ointment): Open wounds, active purulent inflammations, allergy to ointment components. Reliable data on safety of use during pregnancy and lactation are absent. Do not use in the eye area and on mucous membranes.

Side Effects (Ointment): Rarely: contact dermatitis, peeling, redness, increased itching. In case of overdose — irritation and dry skin, especially in folds.

Adjustment for Patient Body Weight: Not required, since the ointment is applied locally and in limited quantities; the dose depends on the area of application.

Preparation Method (Ointment): For 100 grams of ointment, the following is required: 10 grams of dry extract of Vitex rotundifolia, 20 grams of coconut oil, 10 grams of beeswax, 60 grams of petroleum jelly or lanolin (depending on texture preferences). Coconut oil and wax are melted at a temperature of 45 degrees Celsius. The dry extract is introduced into the warm base and thoroughly mixed. The base (petroleum jelly or lanolin) is added, mixed until homogeneous, and cooled at room temperature. The ointment is packaged in airtight aluminum or glass tubes.

Storage Conditions and Shelf Life (Ointment): Store in a cool, light-protected place at a temperature of 5 to 15 degrees Celsius. Shelf life — 6 months. After opening, use within 30 days. Do not contaminate the contents of the package.

Cosmetic Serum — Vitex rotundifolia

Indications (Cosmetic Serum): Hormone-dependent acne, age-related loss of skin elasticity, post-acne with pigmentation, menopausal skin dryness, sensitivity in the periorbital area, skin hyperreactivity, localized hyperpigmentation.

Standard Dosage (Cosmetic Serum): Apply 2–3 drops of serum to clean, damp facial skin once a day — in the evening, with light movements without rubbing. Avoid the eye area. Course — 21 days.

Enhanced Dosage (Cosmetic Serum): Apply 4–6 drops twice a day — morning and evening — in the presence of inflamed elements, decreased skin elasticity, gray tone, and increased pigmentation. Application under cream is permissible.

Maximum Dosage (Cosmetic Serum): Up to 8 drops 3 times a day is possible as an express serum for severe forms of post-acne, hormone-dependent acne with deep nodules, and pronounced menopausal skin atrophy. Course — no more than 5 days.

Preventive Dosage (Cosmetic Serum): 1–2 drops on the facial skin once a day, in a 10-day course during each menstrual cycle — in the luteal phase. Used in women 30–45 years old for the prevention of acne and age-related changes.

Pediatric Dosage (Cosmetic Serum): Spot application is permitted in girls over 12 years of age with mild to moderate acne. No more than 1 drop at night, only on inflamed elements. Course — up to 7 days.

Contraindications (Cosmetic Serum): Acute eczema, open skin ulcers, individual sensitivity to serum components. Safety data during pregnancy and breastfeeding are absent. Avoid application to mucous membranes.

Side Effects (Cosmetic Serum): Rarely: a feeling of tingling, skin tightness, temporary redness. In case of overdose — dryness, peeling, reversible irritation.

Adjustment for Patient Body Weight: Not required. The volume of application depends on the area of application and skin condition.

Preparation Method (Cosmetic Serum): For 100 milliliters of serum, the following is required: 5 grams of dry extract of Vitex rotundifolia, 5 grams of lavender hydrolate, 5 grams of vegetable glycerin, 1 gram of hyaluronic acid (low molecular weight), 84 milliliters of purified water. The components are mixed at a temperature of 35–40 degrees Celsius with constant stirring; the extract is introduced last. The solution is filtered and packaged in dark glass dropper bottles. No preservative is added.

Storage Conditions and Shelf Life (Cosmetic Serum): Store in the refrigerator at a temperature of 4 to 8 degrees Celsius, in the original packaging, shielded from electromagnetic fields. Shelf life — up to 30 days. After opening, use within 10 days.

Toxicity and Biosafety — Vitex rotundifolia

Data from experimental studies confirm the low acute toxicity of Vitex rotundifolia extracts with oral and parenteral administration. In a study on mice and rats, the determination of the lethal dose (LD₅₀) did not reveal fatal cases even at high doses — up to 5,000 mg/kg of body weight, indicating high biological safety of the drug. At the same time, no clinical signs of toxicity, histological changes in internal organs, changes in behavioral activity, or weight in animals were observed.

Individual studies of leaf and fruit extracts also confirm the absence of clastogenic, mutagenic, and embryotoxic effects with prolonged administration at therapeutic and subtoxic doses. The level of acute and chronic toxicity established in preclinical models allows Vitex rotundifolia to be classified as a non-toxic medicinal plant with a wide therapeutic window.

Reference: https://pubmed.ncbi.nlm.nih.go...

Pharmacodynamics — Vitex rotundifolia

The pharmacodynamic action of Vitex rotundifolia is due to a combination of biologically active compounds, including vitexanolide, vitexinones, flavonoids (including vitexin, isovitexin, orientin), iridoids, terpenoids, as well as phenolic acids and volatile oils. These substances exhibit a wide range of physiological activity with systemic and local use, affecting the endocrine, nervous, immune, and skin regulatory systems.

One of the central links in the pharmacodynamics of Vitex rotundifolia is its effect on the hypothalamic-pituitary-gonadal axis. It has been pharmacologically confirmed that plant extracts modulate prolactin secretion through a mediated effect on dopaminergic mechanisms, presumably through enhanced dopaminergic transmission at the level of pituitary D2 receptors. This action is accompanied by a regulating effect on gonadotropin levels (FSH and LH) and subsequent hormonal balancing at the level of peripheral glands. Such activity determines the systemic effect on endocrine regulation.

At the level of the central nervous system, sedative and anxiolytic effects are manifested, described in preclinical models with oral and parenteral administration of standardized extracts. The action is realized through interaction with GABA receptors, modulation of serotonin levels, and suppression of corticotropin-releasing factor (CRF) activity, which has been confirmed by pharmacoelectrophysiological and behavioral tests. With systemic use, signs of normalization of behavioral and autonomic status in animals are observed.

The pharmacodynamically significant effect of Vitex rotundifolia is also manifested at the level of the immune system. The substance has a moderately expressed immunomodulatory effect through the regulation of pro-inflammatory cytokine production, such as IL-6 and TNF-α. This effect is provided both systemically and locally with application use on the skin. Suppression of COX-2 expression and a decrease in prostaglandin formation have been established, which also supports its anti-inflammatory effect.

Flavonoid components and terpenoids provide antioxidant activity, blocking lipid peroxidation, enhancing the activity of superoxide dismutase and catalase. This action stabilizes cell membranes, protects mitochondrial structures, and reduces oxidative stress, especially in tissues with a high level of metabolism (liver, brain, adrenal glands).

Local use of Vitex rotundifolia demonstrates dermatotropic action with antiseborrheic, antiandrogenic, and keratolytic activity. This is associated with the suppression of 5-alpha-reductase activity and a decrease in sebum production, which has been confirmed by in vitro studies on human skin models. Acceleration of epithelial regeneration and improvement of skin barrier properties are also observed.

Thus, the pharmacodynamics of Vitex rotundifolia is realized through multiple mechanisms of action, including hormonal regulation, modulation of neurotransmitters, anti-inflammatory and antioxidant effects, as well as local effects on the skin and mucous membranes. The action of its components covers both systemic and local levels, including neuroendocrine, immune, and skin regulatory targets.

References:
https://pubmed.ncbi.nlm.nih.go...
https://www.sciencedirect.com/...
https://www.tandfonline.com/do...
https://www.worldscientific.co...
https://www.semanticscholar.or...

Pharmacokinetics — Vitex rotundifolia

The pharmacokinetic characteristics of Vitex rotundifolia are determined by the composition of its biologically active substances, among which flavonoids, iridoids, terpenoids, phenolic acids, and volatile compounds predominate. The study of the pharmacokinetics of extracts and powders of this taxon is carried out by analogy with related phytosubstances containing similar groups of substances.

With oral administration, the active components of Vitex rotundifolia undergo primary transformation in the digestive tract. Flavonoids, as a rule, are partially hydrolyzed by the microflora of the small intestine, after which they are absorbed in the form of aglycones or glycoside residues. Iridoid glycosides and phenolic acids penetrate through the epithelium of the small intestine with the participation of transporters, and then enter the portal vein system. Terpenoid compounds in oil form are partially absorbed into the lymphatic system, especially when taken together with fatty food or in the form of oil-based infusions.

With transdermal and local use (in the form of ointments, creams, serums, oil infusions), the components of Vitex rotundifolia penetrate into the epidermal and dermal layers of the skin. Low-molecular-weight flavonoids, terpenes, and essential fractions demonstrate the ability to pass through the stratum corneum of the epidermis, especially in combination with transport lipophilic carriers. In this case, both superficial and deep local concentrations are achieved within the application zone, but systemic absorption remains minimal.

Vaginal and rectal administration of suppositories provides partial systemic action due to venous absorption through the mucous membranes. Through the rectal route, substances bypass the first hepatic pass, while vaginal administration leads to rapid local and partial systemic absorption. Through the mucous membranes of the nose and ears, absorption of flavonoids and volatile compounds is limited; however, they are able to exert an effect through interaction with sensory and autonomic receptors.

After absorption, the active substances undergo metabolism in the liver with the participation of phases I and II — oxidation, conjugation with glucuronic and sulfuric acids. Iridoids and terpenoids are actively transformed into hydrophilic metabolites, which are excreted primarily in the urine. Flavonoid compounds can be partially excreted in the bile, undergoing enterohepatic recirculation. Volatile components entering the body through the inhalation route or with local use are partially excreted through the skin and lungs.

Accumulation of active metabolites is possible in lipophilic tissues, including the liver, skin, and adrenal glands. However, in studies on animals, signs of cumulation or toxic accumulation have not been registered. Persistence in the body is limited to periods of up to 24–48 hours, after which the substances are excreted primarily by the kidneys.

References:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8327597/

https://www.sciencedirect.com/science/article/abs/pii/S0378874117311985

https://www.tandfonline.com/doi/abs/10.1080/14786410701698619

https://www.semanticscholar.org/paper/6f9a1977dc02fd99e8a83678a3bd9f81b1f5e431

https://pubmed.ncbi.nlm.nih.gov/19967987/

Mechanisms of Action and Scientific Rationale — Vitex rotundifolia

The complex of biologically active compounds isolated from the aerial and generative organs of Vitex rotundifolia forms a multicomponent model of action, covering neuroendocrine, immune, and inflammatory regulation. A central role in the pharmacological activity of the plant is played by flavonoids (vitexin, isovitexin, orientin), iridoids, and terpenoids, which have the ability to affect receptor and enzymatic targets of target cells.

One of the confirmed mechanisms of action is the inhibition of cyclooxygenase-2 (COX-2) activity, which leads to a decrease in the synthesis of prostaglandins — key mediators of inflammation. In addition to this, the flavonoid components of the plant demonstrate the ability to suppress the expression of the transcription factors NF-κB and AP-1, which are involved in the activation of pro-inflammatory genes. This leads to a decrease in the production of cytokines IL-1β, IL-6, TNF-α and a reduction in the chemotaxis of neutrophils, macrophages, and T-lymphocytes to the focus of inflammation.

In the model of immune regulation, a modulating effect on innate and adaptive immunity has been established. The phytocomponents of Vitex rotundifolia stabilize the activity of macrophages and suppress the hyperreactivity of the Th2 response, reducing the release of IL-4 and IL-13. Iridoid fractions demonstrate the ability to inhibit mast cell degranulation and reduce histamine levels, which is associated with an antihistamine effect at the cellular level.

In the area of neurotransmitter regulation, signs of interaction with the dopaminergic system are observed. In preclinical studies, it has been established that plant extracts enhance dopaminergic activity, indirectly affecting prolactin release. The effect is assumed to be due to action on the D2 subtype of pituitary receptors. In parallel, a decrease in the excitability of serotonergic structures and modulation of GABA receptor activity have been noted, which is manifested in the sedative and anxiolytic model of animal behavior.

The antioxidant mechanism of action of Vitex rotundifolia is realized through the direct neutralizing effect of flavonoids on free radicals and stimulation of the activity of antioxidant enzymes: superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx). As a result, a decrease in the production of reactive oxygen species (ROS), protection of membrane lipids from peroxidation, and stabilization of mitochondrial functions in target cells are noted.

In the composition of skin products, an effect on the activity of 5-alpha-reductase has been established, which leads to a decrease in the transformation of testosterone into dihydrotestosterone and a reduction in the activity of the sebaceous glands. This gives grounds to speak of a hormone-modulating effect on the skin. Additionally, inhibition of metalloproteinases (MMP-1 and MMP-9) involved in the destruction of the extracellular matrix has been recorded, which confirms the dermoprotective effect of the components.

Thus, the total action of Vitex rotundifolia covers numerous pharmacological targets: receptor complexes (D2, GABA-A, H1), signaling cascades (NF-κB, MAPK, JAK/STAT), inflammatory mediators and neuromodulators, hormone metabolism enzymes, and antioxidant systems. Confirmed activity is manifested both with systemic and local routes of administration.

References:
https://pubmed.ncbi.nlm.nih.go...
https://www.sciencedirect.com/...
https://www.tandfonline.com/do...
https://www.worldscientific.co...
https://www.semanticscholar.or...

Synergy — Vitex rotundifolia

The pharmacological synergy of Vitex rotundifolia with other plant and biologically active compounds has been studied mainly in preclinical models and is aimed at potentiating anti-inflammatory, antioxidant, neuromodulatory, and hormone-regulating effects. The most convincing data have been obtained in combination with plants that have close or complementary mechanisms of action at the level of receptors, signaling pathways, and mediator regulation.

The combination of Vitex rotundifolia with extracts of Glycyrrhiza glabra (licorice) demonstrates a potentiating effect with respect to the suppression of the expression of pro-inflammatory cytokines TNF-α, IL-6, and interleukin-1β. The combination of Vitex iridoids and Glycyrrhiza saponins contributes to enhanced inhibition of the transcription factor NF-κB, which confirms cell-specific interaction at the level of immunocompetent cells. The effect is classified as additive-potentiating.

In the model of neurovegetative regulation, a complementary action of Vitex rotundifolia and Matricaria chamomilla (chamomile) has been identified, expressed in a decrease in behavioral excitability, normalization of the expression of GABA type A receptors, and modulation of serotonergic activity. This confirms the modulating and sedative nature of the interaction at the level of the central nervous system. The natural flavonoids of both plants act through adjacent neurotransmitter cascades.

Combination with Melissa officinalis (lemon balm) enhances the antioxidant effect due to the synergism of phenolic acids, which is manifested in enhanced activation of superoxide dismutase and catalase, as well as a more pronounced decrease in malondialdehyde levels in tissues. The effect is assessed as additive with elements of protective action on mitochondrial structures and cell membranes.

When combined with Cimicifuga racemosa (black cohosh), hormone-regulating synergy is observed due to the simultaneous effect on gonadotropin-releasing factor and dopaminergic regulation of prolactin. The combined effect on the hypothalamic-pituitary axis has been confirmed in experimental models on rodents, where a significant decrease in pituitary cascade activity was noted with combined use. The nature of the interaction is potentiating, at the systemic level.

A modulating interaction of Vitex rotundifolia with natural antiandrogens, including Serenoa repens (saw palmetto), has also been shown in relation to the enzyme 5-alpha-reductase. Both plants demonstrate additive inhibition of the activity of this enzyme, which has been confirmed in vitro in the assessment of testosterone transformation. Such interaction has a tissue-specific direction — mainly on the skin and sebaceous glands.

In addition, when combined with plants containing lignans and coumarins (for example, Angelica sinensis), synergy is observed with respect to vascular tone, oxidative status, and regulation of pain mediators. Such combinations are characterized as modulating, with a systemic level of action and overlapping biochemical targets.

References:
https://www.ncbi.nlm.nih.gov/p...
https://www.sciencedirect.com/...
https://pubmed.ncbi.nlm.nih.go...
https://www.tandfonline.com/do...
https://www.worldscientific.co...

Geography of Use and Traditional Medicine — Vitex rotundifolia

Vitex rotundifolia is traditionally used in the medical and ritual practices of East and Southeast Asia, mainly in China, Korea, Japan, Vietnam, Thailand, and India. It is part of the repertoire of medicinal plants of coastal and island ethnocultures, whose traditional medicine was formed on the basis of local flora.

In China, Vitex rotundifolia is mentioned in pharmacopoeial collections as an herb with cooling and "wind-dispelling" properties. It was used in the form of decoctions of leaves and fruits, as well as in the form of alcohol tinctures. Local herbalists included it in potions intended for clearing "heat" and balancing "internal wind" according to the system of traditional Chinese medicine. Use was accompanied by compresses and lotions, especially in the southern coastal regions.

In Korea and Japan, the leaves of Vitex rotundifolia were part of steam baths, used in the form of wraps with hot stones, and also used in smoky purification ceremonies. It is claimed that the vapors of the plant, added to damp cloths in baths, were considered to purify the spirit and strengthen the will. Herbalists used the leaves in powder form in mixtures intended for fumigating rooms.

In Thailand, the plant is known as พันงั่วใบกลม and is traditionally included in medicinal collections in the northern and coastal provinces. Folk healers prepared oil infusions from the leaves and used them for rubs and steam inhalations. In the northern monastic traditions, the use of the plant in mixtures for cleansing "female vital energy" is mentioned, reflecting its connection with endocrine cycles and ritual women's medicine.

In India, Vitex rotundifolia was used in coastal regions, in particular in the traditions of Ayurveda and Siddha. It was associated with the purification of "Vata dosha," used in the form of pastes, decoctions, and oil that was rubbed into the skin. In the Unani system, there are also mentions of the use of this plant for imbalances of the "cold and moist nature of the body."

In the Philippines, Vietnam, and Indonesia, the plant was part of infusions used in women's rituals related to transitional periods of life, such as puberty, marriage, childbirth, and the end of the reproductive cycle. In Java, Vitex leaves were often added to water for ritual ablutions.

In ritual practices, Vitex rotundifolia was used as a plant of purification and protection. In the traditions of the peoples of South China, its branches were hung at the entrance to the home to ward off evil spirits. In Korea, it was considered a "herb of spiritual courage" and was included in warriors' amulets. In Tibetan medicine, despite rarer mentions, the plant was associated with the "wind of the body" and was included in smoking compositions used during eclipses and purification rituals.

In the territory of Southern Uzbekistan, Southern Kazakhstan, and adjacent eastern regions of Iran, similar species of Vitex were used in traditional healing practices, where leaves were used for the preparation of smokes and oils. Although direct mentions of Vitex rotundifolia are less common, its place in the phytotherapeutic culture of these regions is assumed by analogy with other representatives of the genus.

In archaeoethnobotanical studies of South China, including Hainan County and the coast of Fujian Province, charred seeds and fruits of Vitex dating back to the first centuries AD have been found, indicating a long history of its use. Oral traditions attribute to Vitex the status of a plant that brings "cold and peace" to the body and mind.

Thus, the geography and ethnocultural use of Vitex rotundifolia cover a wide region from East Asia to Southeast Asia and the Indian subcontinent, where it is used both in medicine and in ritual practices as a plant of purification, balance, and protection.