A Clinical Study To Evaluate The Efficacy Of Sawarnakara Lepa In Shwitra (Vitiligo) In Paediatric Age Group.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1)Improvement in Re- pigmentation of Lesions
研究概览
简要总结
Skin is the largest organ of the body and is important not only for protection and regulation but also for cosmetic and psychological wellbeing. In Ayurveda, skin disorders are categorized under Kushtha, among which Shwitra is a notable condition characterized by depigmentation of the skin.Shwitra is a skin disorder described in Ayurveda as a condition characterized by depigmented patches on the skin, can be correlated to Vitiligo
In India, paediatric prevalence is estimated between 0.46–1.9%, with higher rates reported in certain regions.Sawarnakara Lepa is widely used traditionally, but lacks clinical data in Paediatric patients.The study will help in establishing safe, effective Ayurvedic Paediatric protocols.
this is a Prospective, Open-Label, Non-Randomized Controlled Clinical Trial a total 30 pediatric patients will be enrolled and allocated into one group based on the Shwitra (vitiligo) disorder :-
According to Bhaishajya Ratnavali formulation, Savarnakara Lepa comprises
Bakuchi (Psoralea corylifolia) - 1 part
Hartal (Orpiment (mineral origin) - ¼ Part Psoralea corylifolia
Grind both together in mortal, and triturate well with Gomutra (cow’s urine) for 3 hours.
primary outcome will be Improvement in Re-pigmentation of Lesions and Reduction in Lesion Size and Number.
secondart outcome will be Change in Skin Color Uniformity and Cosmetic Acceptance.
during the time period pathya and apathya will be followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 5–16 years diagnosed with Shwitra (vitiligo) with irrespective of gender.
- •Children with mild and moderate hypopigmentation.
- •Children with resistant vitiligo.
- •Stable or slowly progressive lesions 5)Willing and able to participate for the study duration of 60 days.
排除标准
- •White anesthetic spots, which are characteristic of leprosy.
- •Patches in the genital area.
- •Vitiligo patches complicated with eczema.
- •Patients having skin discoloration due to burns.
- •Systemic illness (hepatic, renal, cardiac, etc.) 6)Acute infections or Patients on long-term immunosuppressive drugs.
结局指标
主要结局
1)Improvement in Re- pigmentation of Lesions
时间窗: Interventional for 60 days at every 15th days interval and post treatment follow up for one month
2)Reduction in Lesion Size and Number
时间窗: Interventional for 60 days at every 15th days interval and post treatment follow up for one month
次要结局
- 1)Change in Skin Color Uniformity & Cosmetic Acceptance(2)Reduction in Associated Symptoms (if present)Such as itching, burning sensation.)
研究者
Dr Chudamani Sinha
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010