To study the efficacy of Yavadi lepa with Sarivadyasava in comparison with Yashtimadhuchurna lepa with Sarivadyasava in Vyanga-A controlled randomized clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in reduction of signs and symptoms in patients diagnosed with Vyanga with MASI Score
研究概览
简要总结
A controlled clinical study on the efficacy of Yavadi lepa externally with Sarivadyasava orally in the management of Vyanga (Melasma) in adults of age group 30-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Vyanga (Melasma) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group) 15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be given Yavadi lepa externally in the dose of 5gm mixed with jala with Sarivadyasava orally in the dose of 15ml after food for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial follow up on 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be given Yashtimadhuchurna lepa externally in the dose of 5gm mixed with jala with Sarivadyasava orally in the dose of 15ml after food for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline),15th day, 30th day and after trial follow up on 45th day. The primary outcome measure will be significant improvement noticed in Melasma area and severity index score (MASI) of Melasma after 30 days. The secondary outcome measure will be improvement noticed in reduction of signs and symptoms of Vyanga based on Melasma severity score after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with classical lakshana of Vyanga.
- •Niruja, tanu, shyavavarna mandala. 2.Subjects with either sex irrespective of religion within the age group of 30 to 60 years.
排除标准
- •1.Subjects suffering from other systemic disorders like Addison’s disease, Cushing’s syndrome, Lichen planus pigmentosa, Chronic renal failure, Drug induced photosensitivity, Uncontrolled Diabetes.
- •2.Subjects who are pregnant, lactating women.
- •3.Subjects who are on oral contraceptive pills.
- •4.Subjects with age less than 30 years and more than 60 years.
结局指标
主要结局
Improvement in reduction of signs and symptoms in patients diagnosed with Vyanga with MASI Score
时间窗: 0th day(Baseline), 15th day, 30th day and 45th day
次要结局
- Improvement in reduction of signs and symptoms in patients diagnosed with Vyanga based on Melasma severity score.(0th day(Baseline), 15th day, 30th day and 45th day)
研究者
Dr Amrutha C S
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru