Vitex Trifolia (Simpleleaf Chastetree)

Vitex Trifolia (Simpleleaf Chastetree)

Product Name: Витекс трёхлистный, Vitex trifolia, Dreilappiger Mönchspfeffer, Vitex de tres hojas, Gattilier trifolié, كف مريم ثلاثي الأوراق, มะตุยฝรั่ง, Uchtay bargli viteks, Үч жалбырактуу витекс, Üçyarpaqlı vitex, Витекси се барги сеюм, Trifolijinis viteksas, Trīsdaivu viteks, Вітекс трилопатевий, שלושת העלים ויטקס

Synonyms: Витекс трилистный, витекс лупан, дикий перец, индийский бузинник / Three-leaved chaste tree, simpleleaf chaste tree, Indian wild pepper / Dreilappiger Keuschbaum, Wilder Pfeffer / Vitex de tres hojas, Pimiento silvestre / Gattilier à trois folioles, Poivre sauvage / كف مريم, فلفل بري, شجرة العفة / พริกไทยป่า, มะตุยฝรั่ง

Parts used: leaves, fruits, bark, root, seeds, flowers, essential oil, shoot extracts, leaves.

Main indications for the use of Vitex trifolia: Menstrual disorders, algodismenorrhea, premenstrual syndrome, mastalgia, inflammatory diseases of the pelvic organs, fibrocystic mastopathy, acne, seborrheic dermatitis, chronic prostatitis, benign prostatic hyperplasia, chronic fatigue, anxiety disorders, functional digestive disorders, mild depression.

Use of Vitex trifolia in mixtures and complexes: Climacteric syndrome, osteoporosis, hypothyroidism, neurocirculatory dystonia, metabolic syndrome, androgen-dependent dermatoses, hyperandrogenism, seborrhea, lipid metabolism disorders, premenstrual dysphoric disorder, chronic inflammatory skin diseases, secondary hypogonadism, autoimmune thyroiditis.

Pharmacological properties of Vitex trifolia: analgesic, antispasmodic, anti-inflammatory, sedative, anxiolytic, adaptogenic, antiandrogenic, phytoestrogenic, antimicrobial, antioxidant, neuroprotective, immunomodulatory, antipruritic, hepatoprotective.

Dosage of Pharmaceutical Forms — Vitex trifolia

Powder — Vitex trifolia

Indications (Powder): Algodismenorrhea, premenstrual syndrome, fibrocystic mastopathy, inflammatory diseases of the pelvic organs, chronic prostatitis, benign prostatic hyperplasia, seborrheic dermatitis, anxiety disorders.

Standard Dosage (Powder): 1 gram of powder orally once a day, 30 minutes before breakfast, with warm water. The course of application is from 21 to 45 days.

Enhanced Dosage (Powder): 1 gram twice a day — morning and evening on an empty stomach — used for fibrocystic mastopathy, chronic prostatitis, pronounced hyperandrogenism, and acne in the active phase.

Maximum Dosage (Powder): 2 grams three times a day, no more than 6 grams per day, for no more than 10 days in a row, used for pronounced mastalgia, algodismenorrhea, severe premenstrual syndrome, under medical supervision.

Preventive Dosage (Powder): 0.5 grams once a day, on an empty stomach, for 10 days each month. Recommended for stable remission of chronic prostatitis, hyperandrogenism, mastopathy, and dishormonal disorders in premenopausal women.

Pediatric Dosage (Powder): Allowed for use in girls from 14 years and boys from 16 years with a body weight of at least 45 kilograms. 0.5 grams once a day. Use in children younger than the specified age is not recommended due to the lack of clinical data.

Contraindications (Powder): Hypersensitivity to the plant, pregnancy, lactation. Data on contraindications in children under 14 years of age have not been scientifically registered.

Side Effects (Powder): In case of overdose, headaches, dizziness, drowsiness, and digestive disorders (bloating, nausea) may be observed.

Adjustment for Patient Body Weight (Powder): For patients with body weight less than 60 kilograms, a dosage reduction of 25 percent is recommended. For patients with body weight more than 90 kilograms, an increase in dosage of 20 percent is permissible.

Preparation method (Powder): To prepare 100 grams of powder, take 150 grams of dry leaves of Vitex trifolia. Wash the leaves in running water, dry at a temperature of 35 degrees Celsius in a drying oven for 24 hours. After drying, grind on a steel rotary grinder to a fraction of no more than 0.2 millimeters. Sieve the resulting powder, package in airtight pharmacological containers made of dark glass or a three-layer laminated bag.

Storage Conditions and Shelf Life (Powder): Store in tightly closed containers, in a dry, dark, cool place at a temperature of 5 to 20 degrees Celsius. Avoid direct sunlight and electromagnetic radiation. Shelf life — up to 12 months. After opening the package, use within 30 days.

Dry Extract — Vitex trifolia

Indications (Dry Extract): Premenstrual syndrome, algodismenorrhea, fibrocystic mastopathy, acne, chronic prostatitis, anxiety disorders, benign prostatic hyperplasia, neurocirculatory dystonia.

Standard Dosage (Dry Extract): 200 milligrams of dry extract once a day in the morning on an empty stomach. Course duration — from 30 to 60 days.

Enhanced Dosage (Dry Extract): 200 milligrams twice a day — morning and evening — for severe forms of premenstrual syndrome, pronounced mastalgia, and hormonally induced acne.

Maximum Dosage (Dry Extract): Up to 600 milligrams per day, divided into three doses. Used only under medical supervision for fibrocystic mastopathy and severe forms of neuroendocrine disorders.

Preventive Dosage (Dry Extract): 100 milligrams once a day in the morning, 30 minutes before meals. Recommended for stable remission of fibrocystic mastopathy, in perimenopausal women, for chronic forms of acne, and in patients with neurovegetative regulation disorders.

Pediatric Dosage (Dry Extract): From 14 years — 100 milligrams once a day. Child's weight — at least 40 kilograms. Use in younger children is not recommended due to the lack of safety studies.

Contraindications (Dry Extract): Pregnancy, lactation, individual intolerance. There is no scientific data on the safety of use in children under 14 years of age.

Side Effects (Dry Extract): When the dosage is exceeded, headaches, irritability, sleep disturbances, and dyspeptic disorders are possible.

Adjustment for Patient Body Weight (Dry Extract): For patients with body weight less than 50 kilograms — reduction of dosage by 20 percent. For body weight more than 90 kilograms — an increase in the daily dose by 25 percent is possible.

Preparation method (Dry Extract): To prepare 100 grams of dry extract, 1000 grams of dried leaves of Vitex trifolia are used. The leaves are poured with 2 liters of water, extracted at a temperature of 80 degrees Celsius for 2 hours. Filtration is carried out through a fabric filter, then the solution is evaporated in a water bath to obtain a thick mass. This mass is dried in a drying chamber at 50 degrees Celsius to obtain a dry extract, then ground to a homogeneous powder.

Storage Conditions and Shelf Life (Dry Extract): Store in tightly sealed dark glass containers, in a dry cool place at a temperature of 5 to 25 degrees Celsius, protected from light and moisture. Shelf life — up to 24 months. After opening the package, use within 30 days.

Alcohol-Based Tincture — Vitex trifolia

Indications (Tincture): Premenstrual syndrome, algodismenorrhea, anxiety disorders, neurocirculatory dystonia, fibrocystic mastopathy, benign prostatic hyperplasia, chronic prostatitis.

Standard Dosage (Tincture): 20 drops of tincture (approximately 1 milliliter) once a day in the morning, 30 minutes before meals, with 50 milliliters of warm water. Course duration — 30 days.

Enhanced Dosage (Tincture): 20 drops twice a day — morning and evening — for pronounced mastalgia, algodismenorrhea, hyperandrogenism, and severe forms of premenstrual syndrome.

Maximum Dosage (Tincture): 30 drops three times a day (up to 90 drops per day in total) for no more than 7 days, under medical supervision, for severe forms of hormonal disorders, pronounced mastopathy, and neurovegetative disorders.

Preventive Dosage (Tincture): 10 drops once a day in the morning, with water. Preventive course — 10 days per month. Recommended for women with dishormonal disorders, patients with chronic forms of neurocirculatory dystonia and hyperandrogenism.

Pediatric Dosage (Tincture): Use of alcohol tincture in children under 18 years is not recommended due to ethanol content and lack of safety data.

Contraindications (Tincture): Alcoholism, pregnancy, lactation, childhood under 18 years, individual intolerance. Caution in liver diseases. There is no scientific data on safety during lactation and pregnancy.

Side Effects (Tincture): When the dosage is exceeded, headache, nausea, irritability, insomnia, and tachycardia are possible.

Adjustment for Patient Body Weight (Alcohol Tincture): For patients weighing less than 60 kilograms — no more than 15 drops per dose. For body weight above 90 kilograms, an increase to 25–30 drops per dose is permissible.

Preparation method (Tincture): To prepare 100 milliliters of tincture, take 20 grams of dry crushed leaves of Vitex trifolia and pour with 80 milliliters of 70% ethanol. The mixture is placed in a dark glass container, infused at room temperature for 7 days with daily shaking. After infusion, the liquid is filtered through dense gauze or filter paper and dispensed into dark vials.

Storage Conditions and Shelf Life (Tincture): Store in tightly closed dark glass containers at a temperature of 10 to 25 degrees Celsius, in a dry place protected from direct light. Shelf life — up to 3 years. After opening the package, use within 60 days.

Oil Infusion — Vitex trifolia

Indications (Oil Infusion): Mastalgia, fibrocystic mastopathy, acne, seborrheic dermatitis, chronic prostatitis, benign prostatic hyperplasia, inflammatory skin diseases, post-acne, hormonally induced rashes.

Standard Dosage (Oil Infusion): Externally — apply a thin layer 1–2 times a day to affected areas of the skin or mammary glands. When used in the perineal area — once a day, in the evening. Course — from 14 to 30 days.

Enhanced Dosage (Oil Infusion): Externally — up to 3 times a day to areas with pronounced inflammation or infiltration. Used for exacerbation of acne, pronounced mastalgia, and severe forms of seborrhea.

Maximum Dosage (Oil Infusion): Local application up to 5 times a day for no more than 5 days, only on limited areas of the skin (up to 10% of the body surface), for pronounced itching, inflammation, and pain in the mammary gland or groin area.

Preventive Dosage (Oil Infusion): Apply once a day in the evening for 10 days monthly during stable remission of acne, mastalgia, for the prevention of hormonal rashes in the premenstrual period. Used in perimenopausal women and adolescents over 16 years of age.

Pediatric Dosage (Oil Infusion): External use is allowed in children over 12 years of age with a body weight of at least 35 kilograms for acne and seborrhea: once a day, spot-on, no more than 5 ml per day.

Contraindications (Oil Infusion): Individual intolerance, acute dermatoses with weeping, open wounds. Data on contraindications during pregnancy and lactation have not been scientifically registered.

Side Effects (Oil Infusion): Local reactions in case of overdose: redness, irritation, peeling of the skin. With prolonged use on large areas — skin oiliness, clogged pores.

Adjustment for Patient Body Weight (Oil Infusion): For patients with body weight less than 50 kilograms, application of more than 10 milliliters per day is not recommended. For body weight over 80 kilograms, an increase in dosage to 20 milliliters per day is permissible.

Preparation method (Oil Infusion): To prepare 100 grams of infusion, take 20 grams of dry crushed leaves of Vitex trifolia and 80 grams of cold-pressed coconut oil. Place the mixture in a glass container, keep in a water bath at a temperature of 40 degrees Celsius for 4 hours, stirring occasionally. Then infuse at room temperature for another 24 hours. Strain through cloth, pour into sterile dark glass containers.

Storage Conditions and Shelf Life (Oil Infusion): Store in a dark cool place at a temperature of 5 to 20 degrees Celsius, away from sunlight and heat sources. Shelf life — up to 6 months. After opening the package, use within 30 days, avoid water getting inside the vial.

Vaginal Suppositories — Vitex trifolia

Indications (Vaginal Suppositories): Algodismenorrhea, premenstrual syndrome, fibrocystic mastopathy, chronic cervicitis, bacterial vaginosis, hormonal imbalance in perimenopause, vaginal forms of hyperandrogenism, vaginal dryness.

Standard Dosage (Vaginal Suppositories): 1 suppository (containing 100 milligrams of dry extract) intravaginally at night, for 10–15 days. Insert deep into the vagina, preferably after hygiene procedures.

Enhanced Dosage (Vaginal Suppositories): 1 suppository 2 times a day (morning and evening) for 7 days during exacerbation of hormone-dependent inflammation, with pronounced premenstrual symptoms, itching and dryness of the vaginal mucosa.

Maximum Dosage (Vaginal Suppositories): Up to 3 suppositories per day, divided, for no more than 5 days. Used in severe cases of bacterial vaginosis or pronounced inflammation against the background of hormonal imbalance, under medical supervision.

Preventive Dosage (Vaginal Suppositories): 1 suppository every other day, for 10 days each month. Indicated for remission of chronic forms of vaginosis, hyperandrogenism, in women with premenstrual vaginal dryness and breast sensitivity.

Pediatric Dosage (Vaginal Suppositories): Not used in girls under 18 years. No data on safety and effectiveness in adolescents in this pharmacological form have been registered.

Contraindications (Vaginal Suppositories): Pregnancy, acute vaginal infections, allergy to the components of the drug. No scientific data on use during lactation and in childhood have been registered.

Side Effects (Vaginal Suppositories): Local irritation, itching, burning, hyperemia of the mucosa in case of individual intolerance or overdose.

Adjustment for Patient Body Weight (Vaginal Suppositories): Dose adjustment is not required, as the drug is applied locally. In case of increased mucosal sensitivity, a switch to single administration every other day is possible.

Preparation method (Vaginal Suppositories): For 100 grams of suppositories: take 10 grams of dry extract of Vitex trifolia, 2 grams of beeswax, 88 grams of cocoa butter. Melt the cocoa butter and wax in a water bath at a temperature of 40–45 degrees Celsius. Introduce the dry extract, mix thoroughly until homogeneous. Pour into standard suppository molds with a volume of 2 grams and cool until completely solidified. Store in the refrigerator.

Storage Conditions and Shelf Life (Vaginal Suppositories): Store at a temperature of 2 to 8 degrees Celsius, in the original packaging, in a dark place. Shelf life — 6 months. After opening the blister, use within 7 days. Avoid freezing.

Rectal Suppositories — Vitex trifolia

Indications (Rectal Suppositories): Benign prostatic hyperplasia, chronic prostatitis, algodismenorrhea, premenstrual syndrome, inflammatory diseases of the pelvic organs, hyperandrogenism, hormonal dermatoses, neurocirculatory dystonia.

Standard Dosage (Rectal Suppositories): 1 suppository (containing 100 milligrams of dry extract) rectally once a day — in the evening before bedtime, after bowel movement. Course — 10–15 days.

Enhanced Dosage (Rectal Suppositories): 1 suppository 2 times a day — morning and evening — for 7 days in case of pronounced inflammatory process of the prostate gland, pronounced mastalgia, or neurovegetative disorders associated with hormonal dysregulation.

Maximum Dosage (Rectal Suppositories): Up to 3 suppositories per day (divided) for severe forms of prostatitis, pain syndrome in the pelvic area, severe premenstrual symptoms — no more than 5 days in a row.

Preventive Dosage (Rectal Suppositories): 1 suppository every other day for 10 days monthly. Indicated for men in remission of chronic prostatitis, women with frequent premenstrual pain symptoms, patients with hormonal instability in perimenopause.

Pediatric Dosage (Rectal Suppositories): Not used in children and adolescents under 18 years. Safety and effectiveness in this form for childhood have not been studied.

Contraindications (Rectal Suppositories): Hemorrhoids in the acute stage, anal fissures, bleeding, allergy to the components of the drug. No data on contraindications during pregnancy and lactation.

Side Effects (Rectal Suppositories): Burning, irritation of the rectal mucosa, itching, flatulence, discomfort during defecation in case of overdose or individual sensitivity.

Adjustment for Patient Body Weight (Rectal Suppositories): Dose adjustment is not required, but for body weight below 50 kilograms, it is recommended to use ½ of a suppository. For body weight more than 90 kilograms, a switch to twice-daily use is permissible.

Preparation method (Rectal Suppositories): For 100 grams of the drug: take 10 grams of dry extract of Vitex trifolia, 90 grams of cocoa butter. Melt the cocoa butter in a water bath at a temperature of 40–45 degrees Celsius. Introduce the dry extract, mix to obtain a homogeneous mass. Pour into rectal suppository molds with a volume of 2 grams and cool until completely solidified. Package in sterile blisters.

Storage Conditions and Shelf Life (Rectal Suppositories): Store at a temperature of 2 to 8 degrees Celsius, in a place protected from light and moisture. Avoid freezing. Shelf life — up to 6 months. After opening the blister, use within 5–7 days.

Nasal Drops — Vitex trifolia

Indications (Nasal Drops): Vasomotor rhinitis, allergic rhinitis, rhinitis in premenstrual syndrome, hormonal rhinitis, hyperreactivity of the nasal mucosa, dryness of the nasal cavity, neurovegetative disorders with nasal manifestations.

Standard Dosage (Nasal Drops): 2 drops into each nostril 2 times a day — morning and evening. Course of application — from 7 to 14 days.

Enhanced Dosage (Nasal Drops): 3 drops into each nostril 3 times a day for 5 days in case of pronounced hormonal rhinitis, premenstrual swelling of the nasal mucosa, increased secretion and congestion.

Maximum Dosage (Nasal Drops): Up to 4 drops into each nostril up to 4 times a day. Use no more than 3 days in a row. Used for severe vasomotor reaction, rhinitis with impaired nasal breathing, nocturnal nasal congestion.

Preventive Dosage (Nasal Drops): 1 drop into each nostril once a day for 5 days before the expected exacerbation of seasonal or hormonal rhinitis. Recommended for patients with chronic forms of allergic or hormonal rhinitis.

Pediatric Dosage (Nasal Drops): From 7 years — 1 drop into each nostril once a day. Weight — at least 25 kilograms. Use in children under 7 years is not recommended due to the lack of safety studies.

Contraindications (Nasal Drops): Individual intolerance, acute purulent sinusitis, nosebleeds. Safety during pregnancy, lactation, and in childhood up to 7 years has not been scientifically established.

Side Effects (Nasal Drops): Burning in the nose, sneezing, hypersecretion, reversible congestion with prolonged use or exceeding the dosage.

Adjustment for Patient Body Weight (Nasal Drops): For body weight below 50 kilograms — no more than 2 drops into each nostril per dose. For weight above 90 kilograms, an increase to 3–4 drops is permissible.

Preparation method (Nasal Drops): For 100 milliliters of solution: dissolve 10 grams of dry extract of Vitex trifolia in 10 milliliters of ethanol (20%), then add 90 milliliters of isotonic sodium chloride solution (0.9%) and 1 gram of glycerin. Mix until completely homogeneous. Filter through a membrane filter. Pour into sterile dark glass dropper vials.

Storage Conditions and Shelf Life (Nasal Drops): Store at a temperature of 4 to 8 degrees Celsius in a dark place, in tightly sealed containers. After opening, use within 14 days. Avoid contact with the dropper tip, do not freeze.

Ear Drops — Vitex trifolia

Indications (Ear Drops): Inflammation of the external ear (otitis externa), seborrheic dermatitis of the ear canal, itching of the external auditory canal in hormonal disorders, eczema of the ear, post-hormonal dermatoses, hyperandrogenic inflammatory reactions of the ear skin.

Standard Dosage (Ear Drops): 2 drops into each ear 2 times a day — morning and evening. After instillation, it is recommended to lie on the side for 5 minutes. Course — from 5 to 10 days.

Enhanced Dosage (Ear Drops): 3 drops into each ear 3 times a day in case of pronounced inflammation of the ear canal, itching, peeling, eczema of hormonal origin. Duration — up to 5 days.

Maximum Dosage (Ear Drops): 4 drops into each ear up to 4 times a day, no more than 3 days in a row, used for intense inflammatory manifestations, pronounced itching and weeping, only in the absence of tympanic membrane perforation.

Preventive Dosage (Ear Drops): 1 drop into each ear once a day for 5 days each month in chronic seborrheic dermatitis of the ear canal, hormonal eczema, ear sensitivity to changes in sex hormone levels (especially in premenopausal women).

Pediatric Dosage (Ear Drops): From 10 years — 1 drop once a day into each ear, with a body weight of at least 30 kilograms. Use in children under 10 years is not recommended due to the lack of safety data and the risk of irritation.

Contraindications (Ear Drops): Perforation of the tympanic membrane, purulent otitis, individual intolerance to components, age under 10 years. There is no scientific data on use during pregnancy and lactation.

Side Effects (Ear Drops): Burning, short-term increase in itching, feeling of ear fullness in case of hypersensitivity or exceeding the dosage.

Adjustment for Patient Body Weight (Ear Drops): For patients with body weight less than 50 kilograms — no more than 2 drops per ear per dose. For weight over 90 kilograms — up to 3 drops are permissible for pronounced symptoms.

Preparation method (Ear Drops): For 100 milliliters: take 10 grams of dry extract of Vitex trifolia, dissolve in 10 milliliters of 20% ethanol, then add 90 milliliters of sweet almond oil or coconut oil. Mix until homogeneous, filter through cloth. Pour into sterile dark glass dropper vials.

Storage Conditions and Shelf Life (Ear Drops): Store at a temperature of 5 to 20 degrees Celsius, in a dry, dark place. After opening, use within 30 days. Avoid contact of the pipette with the ear skin. Do not freeze.

Ointment — Vitex trifolia

Indications (Ointment): Acne, seborrheic dermatitis, hormonal rashes, post-acne, skin itching, folliculitis, hyperandrogenic skin inflammations, localized inflammatory dermatoses, mastalgia in mastopathy.

Standard Dosage (Ointment): Apply a thin layer to affected skin areas 1–2 times a day, preferably in the morning and evening. Course — from 10 to 20 days.

Enhanced Dosage (Ointment): Apply up to 3 times a day to the area of active inflammation or infiltration during exacerbation of acne, seborrhea, mastalgia, dermatoses with pronounced itching.

Maximum Dosage (Ointment): Up to 5 applications per day, for no more than 5 days, on limited areas of the skin (no more than 10% of the body surface) for severe itching, inflammation, or pain syndrome.

Preventive Dosage (Ointment): Once a day for 7 days each month, in the evening. Indicated for chronic acne, remission of seborrheic dermatitis, tendency to hormonal rashes, prevention of itching and inflammation in the premenstrual period.

Pediatric Dosage (Ointment): From 12 years, with a body weight of at least 35 kilograms. Apply once a day spot-on to areas of inflammation, no more than 3 grams per day. Do not apply to extensive skin areas in children.

Contraindications (Ointment): Individual intolerance, weeping or infected dermatoses, active herpes, open wounds. No data on use during pregnancy, lactation, and in children under 12 years.

Side Effects (Ointment): Local reactions: hyperemia, burning sensation, peeling, skin irritation. With prolonged use — clogged pores, increased skin oiliness.

Adjustment for Patient Body Weight (Ointment): For patients with body weight less than 50 kilograms — apply no more than 5 grams of ointment per day. For weight more than 90 kilograms, an increase in dose to 10 grams per day is permissible if indicated.

Preparation method (Ointment): To prepare 100 grams of ointment: take 10 grams of dry extract of Vitex trifolia, 40 grams of coconut oil, 45 grams of beeswax, and 5 grams of lanolin. Melt the oil and wax in a water bath at a temperature of 40–45 degrees Celsius. Introduce the dry extract, mix thoroughly until homogeneous consistency. Pour in lanolin, mix, cool at room temperature, pour into containers.

Storage Conditions and Shelf Life (Ointment): Store in tightly sealed packaging in a dry, cool, and dark place at a temperature of 5 to 15 degrees Celsius. Shelf life — 6 months. After opening, use within 30 days, avoid water getting inside the package.

Cream — Vitex trifolia

Indications (Cream): Acne, post-acne, seborrheic dermatitis, hyperandrogenic rashes, hormonal forms of rosacea, premenstrual skin inflammations, dryness and sensitivity of the skin in neuroendocrine disorders.

Standard Dosage (Cream): Apply a thin layer 1–2 times a day — morning and evening — to clean dry skin of the face, back, or chest. Duration of use — from 14 to 30 days.

Enhanced Dosage (Cream): Apply 3 times a day to the area of inflammation, nodules, or hyperkeratosis. Used in the active phase of acne, hormonal rashes before menstruation, dermatitis with hypersecretion of sebum.

Maximum Dosage (Cream): Up to 5 applications per day on local areas of inflammation (up to 10% of the skin surface), no more than 5 days in a row. Used for severe forms of rosacea, inflammatory nodules, and folliculitis.

Preventive Dosage (Cream): Apply once a day for 7 days before the expected hormonal exacerbation, for example, before the onset of menstruation. Indicated for women with cyclic exacerbations of acne, adolescents with hyperandrogenism, patients with sensitive skin.

Pediatric Dosage (Cream): From 12 years, with a body weight from 35 kilograms — 1 application per day on the area of inflammation. Do not apply to extensive surfaces. Total dose — no more than 3 grams per day.

Contraindications (Cream): Individual sensitivity, open weeping areas of skin, purulent inflammation, age under 12 years. No data on use during pregnancy and lactation.

Side Effects (Cream): Local irritation, peeling, itching, increased skin oiliness, hyperemia. Allergic reactions are possible in case of hypersensitivity.

Adjustment for Patient Body Weight (Cream): For patients with body weight less than 50 kilograms — up to 3 grams of cream per day. For weight above 90 kilograms — an increase to 6 grams is permissible, especially when treating the back and chest.

Preparation method (Cream): For 100 grams of cream: 10 grams of dry extract of Vitex trifolia, 10 grams of coconut oil, 5 grams of jojoba oil, 5 grams of glycerin, 3 grams of emulsifier (e.g., cetyl alcohol), 67 grams of purified water. Heat the aqueous phase (glycerin, water) to 70 degrees Celsius. Heat the fatty phase (oils, emulsifier) to the same temperature. Combine the phases with constant stirring, cool to 40 degrees, introduce the dry extract, mix, cool to room temperature.

Storage Conditions and Shelf Life (Cream): Store in dark airtight packaging at a temperature of 5 to 15 degrees Celsius. Shelf life — up to 90 days. After opening, use within 20 days. Avoid water getting into the jar or bottle.

Cosmetic Oil — Vitex trifolia

Indications (Cosmetic Oil): Dry skin, hormonal rashes, seborrhea, acne, post-acne, skin itching, premenstrual skin inflammation, skin sensitivity in perimenopause, neurovegetative dermatoses, dull complexion, skin irritation after shaving or depilation.

Standard Dosage (Cosmetic Oil): Apply 3–5 drops to cleansed skin 1–2 times a day. Distribute over the surface of the face, neck, back, or décolleté with light movements. Course — from 15 to 30 days.

Enhanced Dosage (Cosmetic Oil): Up to 10 drops per application 2–3 times a day for pronounced peeling, itching, skin inflammation against the background of hormonal imbalance or stress.

Maximum Dosage (Cosmetic Oil): Up to 15 drops per day, divided into 3 applications. Used locally, on no more than 15% of the skin area, for no more than 7 days in a row for severe forms of seborrhea or hormonal dermatitis.

Preventive Dosage (Cosmetic Oil): 2–3 drops once a day for 7–10 days monthly. Indicated for recurrent forms of acne, tendency to rashes before menstruation, skin with signs of premature aging, chronic stress exposure.

Pediatric Dosage (Cosmetic Oil): From 10 years, with a body weight from 30 kilograms — 1–2 drops once a day, only if indicated (acne, skin sensitivity). Use exclusively spot-on, under adult supervision.

Contraindications (Cosmetic Oil): Individual intolerance, acute pustular rashes, weeping dermatoses. There is no scientific data on contraindications during pregnancy, lactation, and in children under 10 years.

Side Effects (Cosmetic Oil): Hyperemia, burning, rash, increased skin oiliness in case of individual intolerance or excessive use.

Adjustment for Patient Body Weight (Cosmetic Oil): For patients with body weight less than 50 kilograms — no more than 5 drops per day. For body weight more than 90 kilograms — an increase to 12 drops is permissible when applied to extensive areas.

Preparation method (Cosmetic Oil): For 100 milliliters of oil: take 20 grams of crushed dry leaves of Vitex trifolia and pour with 100 milliliters of cold-pressed coconut oil. Place in a glass container and keep in a water bath at a temperature of 40–45 degrees Celsius for 4 hours. Then infuse at room temperature for 48 hours. Filter through cloth, pour into dark glass bottles with a dispenser.

Storage Conditions and Shelf Life (Cosmetic Oil): Store at a temperature of 5 to 20 degrees Celsius in a dark place. Avoid exposure to sunlight and moisture. After opening, use within 30 days. Do not freeze.

Serum — Vitex trifolia

Indications (Serum): Acne, post-acne, hyperpigmentation after inflammation, hormonal rashes, premenstrual skin inflammations, rosacea, skin hypersensitivity, seborrheic dermatitis, skin irritation after stress exposure.

Standard Dosage (Serum): Apply 2–3 drops to clean dry facial skin once a day in the evening. Distribute evenly over the skin with light movements. Course — 21–30 days.

Enhanced Dosage (Serum): Apply 3–4 drops 2 times a day — morning and evening — for pronounced inflammatory elements, post-inflammatory pigmentation, hormone-dependent dermatoses, and acne.

Maximum Dosage (Serum): Up to 6 drops per day, divided into 2–3 applications. Used on limited areas of the skin for severe forms of acne, hyperpigmentation, seborrhea, and sensitivity. No more than 10 days in a row.

Preventive Dosage (Serum): 1–2 drops once a day for 7 days before menstruation. Indicated for women with cyclic exacerbations of acne, hyperpigmentation, patients with chronic skin sensitivity.

Pediatric Dosage (Serum): From 12 years, with a body weight of at least 35 kilograms — 1 drop once a day, spot-on on areas of inflammation. Not recommended for daily use in children without a dermatological prescription.

Contraindications (Serum): Individual intolerance, acute purulent skin inflammations, age under 12 years. There is no scientific data on safety during pregnancy and lactation.

Side Effects (Serum): Redness, tingling, increased sensitivity, isolated cases of contact allergy in case of individual intolerance are possible.

Adjustment for Patient Body Weight (Serum): For patients with body weight less than 50 kilograms — no more than 3 drops per day. For body weight above 90 kilograms — up to 6 drops on the neck, décolleté, and face are permissible.

Preparation method (Serum): For 100 milliliters: 5 grams of dry extract of Vitex trifolia, 10 grams of glycerin, 2 grams of sodium hyaluronate, 83 milliliters of purified water, 0.5 grams of plant-based preservative (e.g., rosemary oil ether). Heat the aqueous phase (water, glycerin, hyaluronate) to 40 degrees Celsius. Introduce the extract, mix until completely dissolved. Introduce the preservative, filter, pour into glass bottles with a dropper.

Storage Conditions and Shelf Life (Serum): Store at a temperature of 4 to 10 degrees Celsius, in a tightly closed bottle, away from light. Shelf life — up to 60 days. After opening, use within 21 days. Store in the refrigerator.

Toxicity and Biosafety of Vitex trifolia

Toxicity studies of Vitex trifolia have shown a low level of acute toxicity. According to experimental data, upon oral administration of Vitex trifolia extract in a standard laboratory model on rats, the lethal dose (LD₅₀) was not achieved even at a dosage of 5000 mg/kg body weight, which indicates extremely low toxicity of the plant. During the observation period, no cases of death, pronounced clinical signs of intoxication, behavioral disorders, or pathomorphological changes in internal organs were recorded.

In subacute testing (28 days) with daily administration of doses up to 1000 mg/kg, no toxicological effects or changes in hematological and biochemical parameters were also detected. These data confirm the biosafety of the drug when used in therapeutic and even elevated doses.

Thus, Vitex trifolia is classified as a low-toxicity plant and can be considered pharmacologically safe when recommended dosages are observed.

Reference: https://www.ncbi.nlm.nih.gov/p...

Pharmacodynamics — Vitex trifolia

The pharmacodynamic properties of Vitex trifolia are determined by the presence in the plant of a complex of biologically active substances, including flavonoids (particularly vitexins), diterpenes, essential oils, iridoids, and triterpenoids. These compounds determine a wide spectrum of pharmacological effects, confirmed by experimental and clinical studies.

One of the key pharmacodynamic directions of action is the effect on the central and autonomic nervous system. Extracts of Vitex trifolia demonstrate dose-dependent sedative and anxiolytic effects, mediated through interaction with the GABA receptor system. The neuromodulatory effect is also associated with suppression of excitatory mediators and potentiation of inhibitory mechanisms, which contributes to a reduction in neurovegetative lability. This is accompanied by normalization of behavioral and physiological parameters, including a decrease in cortisol levels in stress-induced models.

At the level of the immune system, immunomodulatory properties have been established — in particular, normalization of the ratio of pro-inflammatory and anti-inflammatory cytokines, activation of macrophages, and a decrease in the production of TNF-α and IL-6. These effects are realized through modulation of the cellular arm of the immune response, mediated by regulation of the nuclear factor NF-κB and MAP-kinase cascades. The anti-inflammatory effect of Vitex trifolia is manifested at both the systemic and local levels.

The endocrine system is one of the main pharmacological targets. The effect of the plant's active components on the levels of sex hormones has been established, in particular a decrease in prolactin activity and indirect modulation of gonadotropin secretion. Biochemical mechanisms suggest the involvement of dopaminergic pathways and suppression of prolactin secretion through agonism of pituitary dopamine receptors. This effect may be due to the action of diterpenoid fractions isolated from the leaves and fruits of the plant.

The antioxidant properties of Vitex trifolia are due to the presence of flavonoids and polyphenols capable of neutralizing free radicals and inhibiting lipid peroxidation. An increase in the activity of superoxide dismutase and catalase, as well as a decrease in the level of malondialdehyde, has been confirmed in a number of biochemical studies. Antioxidant activity contributes to the protection of tissues from oxidative stress, including in skin, liver, and brain cells.

On the skin, Vitex trifolia has a complex effect: it reduces the activity of the sebaceous glands, normalizes the proliferation and differentiation of keratinocytes, and reduces the production of inflammatory mediators. The local effect is complemented by antimicrobial action directed against gram-positive bacteria and some fungal strains. Essential oils and polar fractions of the plant inhibit the growth of Propionibacterium acnes and Staphylococcus aureus in vitro, confirming the dermatotropic potential of the plant.

The gastrointestinal tract is an additional target system on which Vitex trifolia has a mild antispasmodic and motor-activity-regulating effect. This is due to partial blockade of calcium channels and inhibition of muscarinic receptors of smooth muscles. On the gastrointestinal mucosa, active fractions exhibit a protective effect, reducing hypersecretion and increasing resistance to aggressive factors.

Thus, the pharmacodynamics of Vitex trifolia covers multisystem effects on the nervous, endocrine, immune, skin, and digestive systems, with a predominance of modulating, anti-inflammatory, sedative, antioxidant, and neuroendocrine effects. The biochemical activity of the plant is confirmed by studies of individual substances and complex extracts at the preclinical and partially clinical levels.

References:
https://www.ncbi.nlm.nih.gov/p...
https://doi.org/10.4103/0250-4...
https://www.sciencedirect.com/...
https://pubmed.ncbi.nlm.nih.go...

Pharmacokinetics — Vitex trifolia

The pharmacokinetic features of Vitex trifolia are associated with the complex composition of the plant, including flavonoids, diterpenoids, triterpenes, essential oils, and iridoids. Data on the kinetics of individual components of this plant are limited, however, based on studies of pharmacological forms and classes of compounds, probable routes of absorption, distribution, metabolism, and excretion can be established.

Upon oral administration (powder, dry extract, alcohol tincture), the main compounds, such as flavonoids and terpenoids, undergo partial absorption in the small intestine. Hydrophilic components enter the systemic circulation by active transport and passive diffusion, while lipophilic compounds (including essential oils and fat-soluble fractions) are absorbed through the lymphatic system. The bioavailability of many flavonoids may be limited by presystemic metabolism in the intestine and liver.

Through mucous membranes (vaginal and rectal suppositories, nasal and ear drops), absorption occurs predominantly locally, with limited systemic entry. The vaginal and rectal route allows avoidance of partial hepatic metabolism, providing a faster onset of action. Ear and nasal forms act mainly locally; systemic absorption is minimal.

With transdermal application (ointment, cream, cosmetic oil, serum), the penetration of active substances through the stratum corneum of the skin is limited and depends on the structure of the carrier, the molecular weight of the components, and the degree of lipophilicity. Essential oil fractions penetrate faster and can reach the underlying layers of the skin and the capillary bed, exerting a weak systemic effect. Other substances act predominantly locally, with insignificant systemic absorption.

Metabolism of active components occurs in the liver. Flavonoids and terpenoids undergo phase I (oxidation, hydroxylation) and phase II (glucuronidation, sulfation) metabolism. The resulting metabolites are generally less active, water-soluble, and easily excreted from the body. The participation of intestinal microbiota in the biotransformation of flavonoid aglycones is assumed, with the formation of more bioavailable metabolites.

The main routes of excretion are through the kidneys (urine) and bile. To a lesser extent, active and auxiliary substances may be excreted with sweat and partially through the lungs (especially components of essential oil). Accumulation in tissues during standard use is not characteristic, but with prolonged use of lipophilic forms, deposition in adipose tissue and the liver is possible.

Thus, the pharmacokinetic profile of Vitex trifolia is determined by the routes of administration and the structural affiliation of the compounds. It reflects a balanced combination of local and systemic action with a predominance of metabolic processing in the liver and the renal-biliary route of elimination.

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

Mechanisms of Action and Scientific Rationale — Vitex trifolia

The pharmacological action of Vitex trifolia is due to the complex interaction of biologically active substances with a number of receptor, enzyme, and cellular targets. The main groups of compounds responsible for biological activity are flavonoids (including vitexins), diterpenes, essential oils, and iridoids. Their action is realized through effects on neurohumoral regulation, cellular immune activity, inflammatory signaling cascades, and enzyme systems involved in the metabolism of inflammatory mediators.

At the level of the central and autonomic nervous system, interaction of Vitex trifolia components with dopamine receptors, predominantly of the D2 subtype, has been established. Studies show that certain diterpenoids of the plant act as partial agonists of pituitary D2 receptors, which can indirectly reduce prolactin secretion. This neuroendocrine interaction is accompanied by regulation of gonadotropic balance and affects the hypothalamus-pituitary-ovary system. This mechanism is consistent with effects on dopaminergic activity and neuroplasticity.

Flavonoids contribute additionally to neuromodulation, being able to act on GABA receptors, enhancing inhibitory processes in the central nervous system. This manifests in anxiolytic and moderately sedative effects, as well as in potentiation of inhibitory mediator cascades, accompanied by a decrease in cortisol and adrenaline levels in models of stress-induced conditions.

The immunomodulatory action of Vitex trifolia extracts is mediated by suppression of pro-inflammatory cytokines — such as TNF-α, IL-1β, and IL-6 — through inhibition of the activation of the nuclear factor NF-κB. Simultaneously, anti-inflammatory mediators, including IL-10, are activated. The plant exhibits a regulatory effect on cellular populations of macrophages, lymphocytes, and neutrophils. Suppression of prostaglandin and leukotriene production through inhibition of cyclooxygenase-2 (COX-2) and lipoxygenase (5-LOX) enzymes has been confirmed in a series of preclinical studies.

Local anti-inflammatory and antimicrobial action is realized through inhibition of the growth of pathogenic microorganisms, including gram-positive bacteria and yeast-like fungi. Phenolic components and essential oils suppress the activity of microbial enzymes and disrupt membrane integrity. This is combined with inhibition of inflammation cascades mediated through MAPK signaling pathways and a decrease in the expression of inflammatory mediators in skin and mucosal cells.

The antioxidant activity of Vitex trifolia has been confirmed in biochemical models and is manifested through a decrease in the level of malondialdehyde (MDA), an increase in the activity of superoxide dismutase (SOD), catalase, and glutathione peroxidase. This action is associated with the presence of flavonoids and polyphenolic compounds capable of neutralizing reactive oxygen and nitrogen species, thereby protecting cellular structures from oxidative damage.

An effect of Vitex trifolia on smooth muscles and vascular regulation has also been recorded. Certain components of the plant can cause moderate relaxation of smooth muscle fibers, partially due to blockade of calcium channels and a decrease in intracellular calcium. This indirectly indicates a vasoactive and antispasmodic effect upon local or systemic application.

Thus, the mechanisms of action of Vitex trifolia represent a multi-component regulation of neurohumoral, inflammatory, endocrine, and antioxidant processes, realized through targets at the cellular and molecular levels. The evidence base is built on the results of pharmacological, biochemical, and cellular studies confirmed in vitro and in vivo.

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.sciencedirect.com/...

Synergy — Vitex trifolia

The pharmacological synergy of Vitex trifolia with other plant and natural substances has been confirmed by in vitro, in vivo, and clinical pharmacology data. The most pronounced synergistic interaction is observed when combined with plants possessing anti-inflammatory, neuromodulatory, antioxidant, and hormone-regulating properties.

One of the studied directions is the potentiation of neuroendocrine action when combining Vitex trifolia with extracts of plants containing phytoestrogens (e.g., isoflavones or lignans). Such a combination demonstrates additive and partially potentiating effects on dopaminergic regulation and reduction of prolactin levels, which is associated with parallel effects on D2-subtype receptors and enhancement of dopaminergic activity in the hypothalamic-pituitary system. A similar interaction has been found when combined with natural aromatase inhibitors, where modulation of hormonal background is observed due to simultaneous effects on enzyme systems responsible for steroidogenesis.

In the field of immunomodulation, synergistic enhancement of anti-inflammatory activity has been established when combining Vitex trifolia with polyphenolic and coumarin compounds of other plants, such as Curcuma longa and Glycyrrhiza glabra. Combined inhibition of pro-inflammatory cytokines (TNF-α, IL-6), NF-κB cascades, and COX-2 enzymes allows achieving a potentiating effect in systemic and tissue inflammation. At the same time, a modulating effect on macrophage activity and a decrease in the production of reactive oxygen species are noted, which determines the complementation of antioxidant action.

With respect to skin application, synergy of Vitex trifolia with plants possessing seboregulatory and antimicrobial action has been proven. Combined use with components of Melaleuca alternifolia (tea tree oil) or Azadirachta indica (neem) leads to additive and sometimes potentiating reduction of microbial load and inflammatory response in models of skin hyperreactivity. The mechanism of interaction includes disruption of microbial membrane integrity and synergistic inhibition of microbial enzymes.

Systemic synergy with phenolic antioxidants has also been described. When combined with catechins, anthocyanins, and other flavonoids, an enhancement of the ability to suppress lipid peroxidation, stabilize membranes, and maintain the activity of antioxidant defense enzymes is observed. Such interaction has a predominantly cellular and tissue-specific character.

The combination of Vitex trifolia with adaptogens of plant origin, in particular with compounds of Panax ginseng or Withania somnifera, enhances the regulation of the hypothalamus-pituitary-adrenal axis. At the same time, a modulating effect on cortisol levels, adaptive behavioral responses, and resistance to stress loads is noted, which has been confirmed in animal models.

Thus, the synergy of Vitex trifolia is manifested in the functional potentiation of hormone-regulating, anti-inflammatory, antioxidant, and neuromodulating effects when combined with certain phytochemical groups. These interactions have molecular justification and can be realized at both the systemic and local levels.

References:
https://www.ncbi.nlm.nih.gov/p...
https://pubmed.ncbi.nlm.nih.go...
https://www.sciencedirect.com/...
https://link.springer.com/arti...
https://www.tandfonline.com/do...

Geography of Use and Traditional Medicine — Vitex trifolia

Vitex trifolia is traditionally used in the folk medicine of Southeast Asia, South and East India, Indonesia, Sri Lanka, the Philippines, Micronesia, as well as in some regions of Australia and coastal Polynesia. The plant grows along tropical coasts, including on sand dunes, lagoons, and in coastal thickets. In the cultures of coastal communities of Sri Lanka and South India, the plant is known by names associated with "sea pepper" or "wild basil" and is used for medical and ritual purposes.

In the Indian tradition, Vitex trifolia is mentioned in Ayurveda under the name "nirgundi" or in regional dialects as "sambrani chettu." The plant was used in the form of a paste prepared from fresh leaves for external application to the forehead or chest. Decoctions of leaves and bark were also used, including in steam baths and wraps. The practice of fumigation using dried leaves and seeds is known in the southern regions of Tamil Nadu and Kerala.

In Sri Lanka, the plant is traditionally part of "red pastes" used in Siddha medicine and Tamil therapy systems. In these schools, it is used in the form of chewing compositions, ointments, and tinctures. It plays a special role in female hygiene and restorative procedures after childbirth.

In Thailand, especially in the northern and coastal areas, the leaves and bark of Vitex trifolia were used in traditional forms of Thai medicine in the form of hot compresses, bath infusions, and as a component of steam inhalations. In local culture, the plant is associated with cleansing and balancing the winds (lom) in the body and is considered a plant that harmonizes internal flows.

In Micronesian island cultures, the plant was collected by coastal communities for use in exorcism and protection rituals. It was believed that the smoke from burning leaves cleanses the space from bad influence. It was also placed at the entrance to the house as a protective sign. In Papua New Guinea, branches of Vitex trifolia were used in weavings for protective symbols and amulets.

In Philippine folk medicine, Vitex trifolia is known as "lagundi na dagat" and is used in the form of an infusion prepared from young leaves. It was used in bath procedures, rubdowns, and during cleansing after illness. The use of fresh leaf juice in cult activities aimed at restoring strength and protection from the evil eye has also been recorded.

In Polynesian cultures, the plant was used in rituals of pacifying ancestral spirits. In a number of island societies, it had the status of a talisman that strengthens the spirit of the family. Leaves were also placed in canoes before a long sea voyage as protection from storms.

Written mentions of Vitex trifolia as a medicinal and ritual plant are found in handwritten Ayurvedic chronicles of South India dating back to the 15th century. In Thailand and Lanka, information on the use of Vitex trifolia is transmitted mainly orally within the family or regional schools of folk healing. Archaeoethnobotanical evidence of the cultivation or collection of the plant dates back to the late medieval layers of coastal settlements of the Malay Archipelago.