Evaluation of vyanghar effect of vyanghar ghrita - an open label clinical trial.
试验速览
- 阶段
- 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
- Vyanghar regimen may show positive results in reducing Vyang on face offering even complexion.
研究概览
简要总结
The study will be conducted after obtaining permission from institutional ethics committee and will be registered prospectively with CTRI, INDIA.
. As per inclusive/exclusive criteria, patients will be selected. 3. Whole research procedure and aim will be clearly informed to the subject and informed written consent (ICF) will be collected from the subject and case record form (CRF) will be used to obtain history and total information of subject regarding disease that is vyang.
Once a patient will be enrolled on day 0, a patch test will be conducted.
Procedure to perform a patch test.
Product will be applied to a small patch of skin where a person is unlikely to accidentally wash or rub it away. Good areas may include the inside of the arm or bend of the elbow.
Product will be applied to a quarter-sized patch of skin. A person should apply the product as thickly as they would when using it regularly. c. Product will be leave on the patch of skin for as long as it would normally be on the skin
A reaction may not happen immediately, so it is important to keep it for e. 24-48hrs. If a person’s skin reacts to the product, they should wash it off as soon as possible and stop using it. A person can use a cold compress or shatadhauta ghrita lepa/dashang lepa to relieve the skin if needed.
If the subject fails the patch test, then they will not be included in the study.
Case report format will be used to obtain history of patient.
Local application of ghrita 5-10 drops day and night time every day for 30 days.
Follow ups will be conducted every 10 days (about 1 and a half week)
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
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with symptoms of Vyang on face
- •Age group- 20-
- •Chronicity less than 1 year.
- •Post inflammatory hyperpigmentation.
- •Post injury hyperpigmentation.
- •patient showing no irritancy in patch.
排除标准
- •Postburn injury hyperpigmentation.
- •K/C/O Malignant melanoma.
- •Patient on steroids or other medication for hyperpigmentation.
- •Hyperpigmentation due to systemic and endocrinal diseases.
- •Hyperpigmentation since birth.
结局指标
主要结局
Vyanghar regimen may show positive results in reducing Vyang on face offering even complexion.
时间窗: Duration of study- This study will be conducted over 30 days. Follow ups will be conducted every 10 days. Size of the vyang will be assessed by fitzpatric scale and dermascope.
次要结局
- not applicable
研究者
Sayongeeta Dhananjay Patil
Bharati vidyapeeth ayurved college(deemed to be university), pune