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临床试验/CTRI/2025/12/098490
CTRI/2025/12/098490尚未招募2/3 期

Effect of mukhalepa visha chikitsa in mukhadushika w.s.r. to acne vulgaris- An open labelled clinical trial

DR AKANKSHA AJIT KANEKAR1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction in Global Acne Grading System(GAGS) Score

研究概览

简要总结

Acne vulgaris is one of the most prevalent chronic inflammatory dermatoses worldwide, primarily affecting the pilosebaceous units of the face, chest, and back. Globally, it is estimated that 9.4 percent of the population is affected by acne, making it the eighth most prevalent disease. From an Ayurvedic perspective, Mukhadushika is described under Kshudra roga, characterized by Shalmali kantaka sadrisha pidakas predominanatly on the face.

In India, recent epidemiological studies suggest that acne affects up to 60 to 70 percent of adolescents and young adults, with increasing incidence in females aged 15 to 30 years. Current therapeutic approach includes topical and systemic retinoids, antibiotics, benzoyl peroxide and hormonal agents for symptomatic relief. Long term use poses challenges like antibiotic resistance, photosensitivity, teratogenicity, relapse post-therapy, and limited tolerability. Factors like poor diet, urban pollution and altered gut skin axis can lead to a state resembling Visha dushti, manifesting as twak vikara.Visha Chikitsa, traditionally used to neutralize and expel toxins, can be conceptually extended to manage skin conditions where toxic byproducts, immune hypersensitivity, or impaired dhatvagni may be involved.

In Mukhadushika clinically, the lesions are described as Shalmali Kantakopama Pidaka, eruptions resembling the thorns of Shalmali tree, indicating hard, painful, and inflamed lesions consistent with acne. Parallelly, Ashtanga Sangraha in the context of Visha Chikitsa describes a condition known as Mukhalepa Visha, presenting with symptoms such as Padmini Kantaka Pidaka, which are elevated eruptions resembling the thorns of a lotus plant. Although attributed to toxic external applications, the morphological similarity of these eruptions to those seen in Mukhadushika is notable.

The present clinical trial proposes the application of madhukapayasyadi lepa, and administration of Bilwadi agada internally, having pharmacological activities, which are Vishghna ,Shothaghna, Janthughna and Krimighna. Studies have shown it to be anti-microbial, antiseptic and antifungal. This dual approach aims to not only treat acne but also to explore the therapeutic versatility of Agada Tantra in dermatology and support long term dermal health without the drawbacks of conventional drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1 Subjects presenting with lakshnans like Pidika Shopha Daha Ruja Kandu 2 Participants diagnosed with Acne vulgaris with mild to moderate acne as per simple clinical assessment or GAGS score less than 31 3 Participants willing for informed consent and follow up.

排除标准

  • 1 Pregnancy lactation and known or suspected cases of Polycystic ovarian syndrome 2 Patients with clinically diagnosed hormonal imbalances like thyroid disorders 3 Complicated acne associated with infection or participants taKing medicines for acne treatment for more than 3 months 4 Subjects with other skin disorders like Rosaceae Acne fulminans Acneiform eruptions 5 Subjects with acne having inflammatory cysts and nodules 6 Participants suffering from major systemic disorders like Uncontrolled hypertension Diabetes mellitus Ashtma Tuberculosis HIV.

结局指标

主要结局

Reduction in Global Acne Grading System(GAGS) Score

时间窗: Baseline,14th and 28th day

次要结局

  • Global acne grading system score(Baseline,14th and 28th day)

研究者

发起方
DR AKANKSHA AJIT KANEKAR
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR AKANKSHA AJIT KANEKAR

KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India

研究点 (1)

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