A Comparative Clinical Study To Evaluate The Efficacy Of Vatapatradi Lepa With And Without Ksheeradhuma In The Management Of Mukhadushika (Acne Vulgaris)
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in the signs and symptoms of Mukhadushika (Acne Vulgaris) — i.e., reduction in symptoms such as Pidika (papules and pustules), Kandu (itching), Daha (burning), Srava (secretion/discharge), Paka (suppuration), Vedana (pain), Medogarbhatva (oily/greasy nature of lesion) assessed using a standardized gradation system for each symptom and the Global Acne Grading System (GAGS) as the objective parameter.
研究概览
简要总结
The proposed study titled A Comparative Clinical Study to Evaluate the Efficacy of Vatapatradi Lepa with and without Ksheeradhuma in the Management of Mukhadushika (Acne Vulgaris) aims to scientifically validate an Ayurvedic approach for acne management through external Panchakarma therapies. Mukhadushika, described under Kshudraroga by Acharya Sushruta, is a Kapha-Vata predominant disorder involving Rakta Dhatu, characterized by Pidika (papules and pustules) resembling Shalmali Kantaka. Modern acne vulgaris, a chronic inflammatory condition of the pilosebaceous unit, affects up to 90% of adolescents and has considerable psychological impact.
Current modern treatments such as antibiotics, retinoids, and hormonal agents carry risks of side effects and recurrence, highlighting the need for safe and effective alternatives. In Ayurvedic practice, Lepa (herbal paste application) has proven useful, but the combined effect of Ksheeradhuma (medicated milk steam) and Vatapatradi Lepa remains unexplored. Ksheeradhuma is a type of Snigdha Nadi Sweda that helps liquefy morbid doshas, open skin pores, and facilitate deeper drug absorption, while Vatapatradi Lepa possesses Rakta Shodhaka, Twaka Prasadana, and Vata-Kaphahara properties beneficial in acne.
This randomized comparative clinical trial will enroll 40 patients aged 18–30 years diagnosed with Mukhadushika. Participants will be divided into two groups Group A receiving Ksheeradhuma followed by Vatapatradi Lepa, and Group B receiving only Vatapatradi Lepa for 15 days. Assessment will be based on classical signs and symptoms (e.g., Pidika, Daha, Kandu, Srava, Shotha, Vaivarnya) and modern acne grading systems (GAGS).
The study hypothesizes that the addition of Ksheeradhuma enhances the therapeutic efficacy of Vatapatradi Lepa by improving circulation, skin detoxification, and local drug penetration. The outcome is expected to offer a cost-effective, natural, and holistic Ayurvedic protocol for acne management, minimizing adverse effects while promoting Twaka Prasadana (healthy skin) and patient well-being.
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
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 to 35 years Patients fulfilling the criteria of Mukhadushika presenting with clinical symptoms like Pitika Ruja Raktima Kandu Patients willing to provide informed consent prior to initiation of the study procedure.
排除标准
- •Patients aged less than 18 years and more than 35 year Patients having other skin diseases like psoriasis atopic dermatitis skin tuberculosis leprosy etc Patients with a history of any drug allergies Patients with systemic illness and hormonal disorders like diabetes hypertension cardiac problem etc Patients taking steroid or hormonal therapy Patients having acne vulgaris other than face region like chest and back Patients who are not willing to give written consent Patients who have any immunosuppressive disease like HIV cancer or severe anemia.
结局指标
主要结局
Improvement in the signs and symptoms of Mukhadushika (Acne Vulgaris) — i.e., reduction in symptoms such as Pidika (papules and pustules), Kandu (itching), Daha (burning), Srava (secretion/discharge), Paka (suppuration), Vedana (pain), Medogarbhatva (oily/greasy nature of lesion) assessed using a standardized gradation system for each symptom and the Global Acne Grading System (GAGS) as the objective parameter.
时间窗: Day 1 – Before treatment (Baseline), Day 7 – After treatment, Day 15 – After treatment, Day 30 – Follow-up
次要结局
未报告次要终点
研究者
Dr Jigna Jayeshbhai Parmar
G. J. Patel Institute Of Ayurvedic Studies And Research