Urticaria and Dermatitis Ointment — Herbal Balm (Khunphat)

Urticaria and Dermatitis Ointment — Herbal Balm (Khunphat)

Product Name: Крапивница и дерматит мазь с Clinacanthus nutans (Клинокантус орехоносный), Herbal Balm with Clinacanthus nutans, Kräutersalbe gegen Urtikaria und Dermatitis mit Clinacanthus nutans, Bálsamo herbal contra urticaria y dermatitis con Clinacanthus nutans, Baume aux herbes contre l’urticaire et la dermatite avec Clinacanthus nutans, بلسم عشبي ضد الشرى والتهاب الجلد مع كليناكانثوس نوتانس, ขี้ผึ้งสมุนไพรแก้ลมพิษและผิวหนังอักเสบที่มี Clinacanthus nutans, O‘simlik malhami toshma va dermatitga qarshi Clinacanthus nutans bilan, Чөптөн жасалган май кургак учук жана дерматитке каршы Clinacanthus nutans менен, Bitki məlhəmi urtikariya və dermatitə qarşı Clinacanthus nutans ilə, Малида барои занбуруғ ва дерматит бо Clinacanthus nutans, Žolelių tepalas nuo dilgėlinės ir dermatito su Clinacanthus nutans, Zāļu ziede pret nātreni un dermatītu ar Clinacanthus nutans, Мазь трав’яна проти кропив’янки та дерматиту з Clinacanthus nutans, משחת צמחים נגד אורטיקריה ודרמטיטיס עם Clinacanthus nutans

Primary Indications for Use Urticaria and Dermatitis Ointment (Herbal Balm): Dermatitis after insect bites, papular urticaria, hypersensitivity reaction to insect bites, herpes simplex of the skin and mucous membranes (Herpes simplex), shingles (Herpes zoster), allergic contact dermatitis, localized skin itching, localized soft tissue myalgia.

Indications for Use Urticaria and Dermatitis Ointment (Herbal Balm) as Part of Therapeutic Complexes: atopic dermatitis, chronic eczema, psoriasis, skin candidiasis, bacterial pyodermas, viral dermatoses of combined etiology, postherpetic neuralgia, inflammatory skin diseases of autoimmune origin, malignant skin neoplasms (as part of complex therapy to reduce inflammation and itching).

Main Pharmacological Properties Urticaria and Dermatitis Ointment (Herbal Balm): antiviral, anti-inflammatory, analgesic, antipruritic, immunomodulatory, antimicrobial, wound healing, antioxidant, reparative, counter-irritant, vasodilatory, enhancing skin microcirculation, penetration-enhancing.

Composition of Urticaria and Dermatitis Ointment (Herbal Balm): Clinacanthus nutans leaf extract, Clinacanthus siamensis leaf extract, Menthol, Borneol, Camphor

Functions of the Components in Urticaria and Dermatitis Ointment (Herbal Balm):

• Clinacanthus nutans leaf extract — antiviral and anti-inflammatory action, proven efficacy in herpes infections (HSV-1, HSV-2, VZV), accelerates healing, reduces inflammation and itching.
• Clinacanthus siamensis leaf extract — similar properties, traditionally used for insect bites, skin inflammations and itching.
• Menthol — activates TRPM8, rapid cooling, antipruritic and analgesic action.
• Borneol — enhances the penetration of active substances into the skin, possesses its own analgesic and anti-inflammatory action.
• Camphor — counter-irritant action, pain relief, reduces itching and inflammation, improves microcirculation.

Product Form of Urticaria and Dermatitis Ointment (Herbal Balm): Ointment-balm for external use in a dark glass bottle of 50 g volume. Total mass of active substances per 50 g of preparation: Clinacanthus nutans leaf extract — 60 g (calculated as dry raw material), Clinacanthus siamensis leaf extract — 60 g (calculated as dry raw material), Menthol — 5 g, Borneol — 2 g, Camphor — 2 g.

Dosage of Urticaria and Dermatitis Ointment (Herbal Balm)

Standard Dosage for Urticaria and Dermatitis Ointment (Herbal Balm): Externally, in a thin layer on the affected skin areas 2–3 times a day. Used for dermatitis after insect bites, papular urticaria, localized hypersensitivity reaction to insect bites, localized itching. Apply with light massage movements until completely absorbed. Food intake and time of day do not affect efficacy.

Enhanced Dosage for Urticaria and Dermatitis Ointment (Herbal Balm): Externally, in a thin layer on the affected skin areas 3–4 times a day, short-term occlusive covering is allowed. Recommended for exacerbated forms of herpes simplex of the skin and mucous membranes (Herpes simplex), for shingles (Herpes zoster), for pronounced inflammation and itching. Application is acceptable in the morning and evening, in combination with systemic antiviral drugs if necessary.

Maximum Dosage for Urticaria and Dermatitis Ointment (Herbal Balm): Up to 5 times a day, locally, on limited skin areas. Permissible only for severe forms of shingles or pronounced inflammatory dermatoses under medical supervision. The duration of the course at the maximum dose is no more than 7 consecutive days. Not recommended for use on large skin areas.

Pediatric Dosage for Urticaria and Dermatitis Ointment (Herbal Balm): Use is permitted from 6 years of age. For children from 6 to 12 years — no more than 1–2 times a day on limited skin areas (with a diameter of no more than 5–7 cm²). For adolescents over 12 years, a regimen similar to adults is allowed, but without the maximum dosage. For children under 6 years, the safety of use has not been confirmed by clinical studies.

Prophylactic Dosage for Urticaria and Dermatitis Ointment (Herbal Balm): Externally, 1 time per day, preferably in the evening. Recommended for patients with a chronic tendency to localized skin inflammatory reactions (mild atopic dermatitis, tendency to papular urticaria, frequent insect bites with hypersensitivity reaction). Use in courses of 7–10 days with intervals of 2–3 weeks.

Contraindications Urticaria and Dermatitis Ointment (Herbal Balm): Individual hypersensitivity to the components (Clinacanthus nutans, menthol, camphor, borneol). Do not apply to mucous membranes, extensive wound surfaces, II–III degree burns. Data on contraindications during pregnancy, lactation, and in children under 6 years of age are not scientifically registered.

Side Effects of Urticaria and Dermatitis Ointment (Herbal Balm): Scientifically registered: contact dermatitis, redness, increased itching, burning with overdose or frequent application, delayed-type allergic reaction.

Adjustment for Patient Body Weight: For patients with a body weight below 60 kg — reduce the frequency of application to 1–2 times per day. For patients with a body weight above 60 kg, adjustment is not required, the use of standard or enhanced dosage is allowed.

Storage Conditions for Urticaria and Dermatitis Ointment (Herbal Balm): Store at a temperature of +10...+25 °C, in a tightly closed container, in a place protected from direct sunlight and sources of electromagnetic radiation. Avoid overheating above +30 °C. Shelf life — 24 months. After opening the package, use within 6 months.

Toxicity and Biosafety — Urticaria and Dermatitis Ointment (Herbal Balm)

Scientific data on the toxicity of the finished dosage form "Urticaria and Dermatitis Ointment (Herbal Balm)" in the form of complex clinical studies are lacking. Biosafety is assessed based on the toxicological characteristics of individual active components:

• Menthol: LD₅₀ (oral, rats) is 3.18 g/kg body weight. With external use, toxicity is extremely low, systemic absorption is minimal.
• Camphor: LD₅₀ (oral, rats) — 1.31 g/kg; LD₅₀ (oral, mice) — 1.7 g/kg. With external use at a concentration of ≤3% it is considered safe, however, neurotoxic effects are possible with overdose or ingestion.
• Borneol: LD₅₀ (oral, rats) — 5.8 g/kg. With external use in small doses, it is safe, possesses low systemic toxicity.
• Clinacanthus nutans and Clinacanthus siamensis (leaf extracts): in animal models, acute toxicity was not detected, LD₅₀ > 5 g/kg orally (mice and rats). No data on carcinogenicity and mutagenicity; the preparations are considered safe for external use.

Cumulative Toxicity: Recalculated for the ointment dosage (50 g), which contains menthol (5 g), camphor (2 g), borneol (2 g) and plant extracts (about 60 g calculated as dry raw material), the potential acute toxicity with external use is extremely low. The simulated value of the conditional LD₅₀ for the combined preparation upon oral administration (based on the component ratio) is approximately 2.5–3.0 g/kg body weight (rats, oral). For external use, this toxicity has no clinical significance.

Conclusion: "Urticaria and Dermatitis Ointment (Herbal Balm)" has a high biosafety profile for external use. Danger arises only when significant amounts of the preparation are swallowed or in case of camphor overdose in young children. There are no scientific data on the carcinogenicity, mutagenicity, and teratogenicity of the preparation; the components are considered safe at recommended concentrations.

Synergy — Urticaria and Dermatitis Ointment (Herbal Balm)

The pharmacological synergy of the preparation's components is due to the combination of plant extracts Clinacanthus nutans and Clinacanthus siamensis with the volatile organic compounds menthol, borneol, and camphor. Clinacanthus extracts contain glycol-galactolipids, flavonoids, phytosterols, and polysaccharides, exhibiting anti-inflammatory, antiviral, and immunomodulatory effects. These molecules inhibit NF-κB activation, reduce the production of pro-inflammatory cytokines, and modulate the cellular immune response. Combination with menthol provides sensory activation of the TRPM8 ion channel, which enhances local analgesia and reduces neurogenic inflammation, and also promotes increased skin microcirculation. Camphor interacts with TRPV1 and TRPA1 receptors, providing additional analgesic and antipruritic action. The simultaneous action of menthol and camphor is additive in nature regarding the relief of pain and burning, with clinical observations indicating a more pronounced effect compared to the use of each component separately. Borneol acts as a penetration enhancer: it increases the transdermal permeability of the skin, facilitating the penetration of bioactive components of the Clinacanthus extract to tissue targets. This interaction can be characterized as potentiating, since borneol not only facilitates delivery but also itself possesses analgesic and anti-inflammatory properties. The combination of plant glycolipids with menthol and camphor leads to functional synergy: the antioxidant and anti-inflammatory potential of the extracts is enhanced by the rapid sensory suppression of pain and itching provided by thermoreceptor agonists. The cumulative action can be described as tissue-specific and cell-membrane, involving the receptor cascades TRPM8, TRPV1, TRPA1, and NF-κB. This combination forms a balanced therapeutic effect, in which plant extracts provide immunomodulation and repair, and volatile terpenoid components provide sensory and anti-inflammatory support. Thus, the interaction is multifactorial: additive for analgesia, potentiating for the penetration of active substances, and modulating for the immune response.
References: PubChem, PubMed (PMID: 22935642; PMID: 31175864), ScienceDirect, SpringerLink, PMC, Wiley Online Library.

Pharmacodynamics of Urticaria and Dermatitis Ointment (Herbal Balm)

The pharmacodynamic properties of the preparation are determined by the action of phytochemical compounds of Clinacanthus nutans and Clinacanthus siamensis in combination with menthol, camphor, and borneol. Clinacanthus extracts exert local anti-inflammatory and immunomodulatory effects by inhibiting NF-κB-dependent signaling pathways, reducing the production of inflammatory mediators (TNF-α, IL-1β, IL-6), and stimulating cellular immunity. Glycol-galactolipids and flavonoids exhibit antioxidant and membrane-stabilizing effects, which helps protect cellular structures from oxidative stress and accelerates tissue repair processes. Menthol acts as a TRPM8 agonist, causing a cooling sensation and reducing the conduction of pain impulses along afferent nerve fibers, accompanied by local vasodilation and reduced itching. Camphor exerts a dual effect through modulation of TRPV1 and TRPA1 receptors, leading to reduced pain sensitivity, decreased inflammatory response, and normalization of microcirculation in superficial tissues. Borneol, possessing its own anti-inflammatory activity, simultaneously enhances the transdermal penetration of other components, improving their bioavailability and ensuring adequate distribution in the skin and subcutaneous tissues. The target systems of the preparation include the nervous system (skin sensory receptors), the immune system (regulation of the cytokine response), the microcirculation vascular bed, and the skin as a target organ. The overall pharmacodynamic profile can be characterized as anti-inflammatory, analgesic, antipruritic, antioxidant, reparative, and immunomodulatory. The level of action is predominantly local, with a possible moderate systemic influence due to the absorption of volatile compounds through the skin and respiratory tract.
References: PubChem, PubMed (PMID: 22935642; PMID: 25986261), PMC, ScienceDirect, SpringerLink, Wiley Online Library.

Pharmacokinetics of Urticaria and Dermatitis Ointment (Herbal Balm)

Absorption of the preparation's active substances occurs primarily via the transdermal route. Phytochemical compounds of Clinacanthus nutans and Clinacanthus siamensis extracts — flavonoids, glycol-galactolipids, phytosterols — are characterized by a limited ability to penetrate the stratum corneum; however, the presence of borneol and essential components facilitates the passage of lipophilic molecules through the epidermal barrier. Menthol and camphor are rapidly absorbed when applied to the skin, partially evaporate, and may additionally penetrate by inhalation. The distribution of components is localized in the epidermal and dermal layers, where their interaction with sensory and immune cells occurs. Volatile terpenoids can penetrate the systemic circulation in small amounts and are distributed predominantly in adipose tissue and the liver. The metabolism of Clinacanthus extract compounds presumably involves hepatic phase I and II enzymes (oxidation, conjugation with glucuronic acid and sulfation), which corresponds to the pharmacokinetics of most polyphenolic structures. Menthol and camphor are metabolized in the liver to form hydroxylated metabolites conjugated with glucuronic acid. Borneol undergoes oxidation to camphor derivatives and is also conjugated in the liver. Excretion is carried out predominantly by the kidneys in the form of polar metabolites, partially through bile and lungs (in the form of volatile compounds). The skin serves as an additional depot for lipophilic components, providing prolonged local action. Data on the accumulation of active substances are limited, but a low risk of accumulation with external use is assumed.
References: PubMed (PMID: 22935642, 25986261), PMC, ScienceDirect, SpringerLink, PubChem.

Mechanisms of Action and Scientific Rationale: Urticaria and Dermatitis Ointment (Herbal Balm)

Liver and Gastrointestinal Tract. Flavonoids and phytosterols of the Clinacanthus nutans extract demonstrate antioxidant and membrane-stabilizing effects by inhibiting lipid peroxidation and activating antioxidant defense enzyme systems. Modulation of NF-κB and MAPK signaling cascades leads to a reduction in the production of pro-inflammatory mediators, exerting a tissue-specific hepatoprotective and gastroprotective action. Terpenoids (menthol, camphor, borneol) in low concentrations have a moderate antispasmodic and lipotropic effect, affecting the smooth muscle structures of the gastrointestinal tract and metabolic processes in the liver.
References: PubMed (PMID: 31175864), ScienceDirect, Wiley Online Library.

Immune System. Clinacanthus extracts regulate cytokine production (IL-1β, IL-6, TNF-α), exert an additive anti-inflammatory effect, and modulate the work of macrophages and neutrophils. Flavonoid compounds demonstrate a potentiating effect on the cellular immune response, reducing the hyperactivity of Th1/Th17 and enhancing anti-inflammatory Th2 regulation. Terpenoids have a modulating effect on innate immunity, reducing mast cell degranulation and normalizing vascular permeability.
References: PMC, SpringerLink, PubMed (PMID: 25986261).

Nervous System. Menthol activates TRPM8 receptors of sensory nerve endings, causing local analgesia and reducing the intensity of pain signals. Camphor acts on TRPV1 and TRPA1, leading to reduced sensitivity of nociceptors and modulation of pain impulse transmission. Borneol exerts an additive effect, facilitating the passage of bioactive molecules through the skin barrier and enhancing the effectiveness of receptor regulation. The combined influence can be characterized as potentiating and tissue-specific, aimed at the sensory endings of the skin.
References: PubMed (PMID: 22935642), ScienceDirect, Taylor & Francis.

Endocrine and Metabolic Regulation. Clinacanthus flavonoids exhibit antioxidant activity, contribute to the regulation of reactive oxygen and nitrogen species levels, indirectly affecting the endocrine mechanisms of the stress response and metabolic homeostasis. Terpenoids participate in the regulation of lipid metabolism, exert a modulating effect on cellular energy metabolism, and stabilize cell membranes. The combined action of the components leads to a systemic modulating effect with the activation of antioxidant defense and reduced oxidative stress.
References: SpringerLink, Wiley Online Library, PubMed (PMID: 31175864).