A Randomised control study of Pippali mool (root of pipper longum Linn) arka in Sthaulya .
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Waist circumference
研究概览
简要总结
Obesity (Sthaulya) is a growing global health concern associated with numerous metabolic disorders. Traditional Ayurvedic medicine offers several remedies, among which Pippali Mool (root of Piper longum Linn) is noted for its Lekhana (scraping), Medohara (fat-reducing), and Deepana (digestive) properties.
This randomised control study aims to evaluate the clinical efficacy of Pippali Mool Arka (distilled extract) in managing Sthaulya. Participants diagnosed with obesity are randomly divided into two groups: one receiving Pippali Mool Arka and the other receiving no treatment. The study measures parameters like weight reduction, BMI, waist-hip ratio and subjective symptoms (e.g., lethargy, excessive appetite) over a fixed period.
The expected outcome is that Pippali Mool Arka will show statistically significant improvement in managing Sthaulya, validating its traditional use and suggesting its potential for broader therapeutic application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Irrespective of gender (Male, female) Patient with BMI ranging between 25-40 Patient with classical symptoms of sthaulya roga like Kshudrashwasa, Nidradhikya(Drowsiness),Pipasa(Thirst),Daurbalya(Weakness),Kshudhadhiky a(Excessive Hunger), Swedadhikya (Sweating), Daurgandhya (Bad Smell) Age-20-50years Religion-no barrier.
排除标准
- •Patient having major cardiac disorders, hormonal disorders,Infectious disease or any other major illness, pregnancy, lactating mothers and Diabetes mellitus.
- •Patient with BMI greater than 40 Patient on prolonged medications like corticosteroids, NSAIDS, antidepressants, or any drugs that may influence on the outcome of study.
结局指标
主要结局
Waist circumference
时间窗: 15 days after 1st visit | 30 days after 2nd visit | 45 day after 3rd visit
Hip
时间窗: 15 days after 1st visit | 30 days after 2nd visit | 45 day after 3rd visit
ratio
时间窗: 15 days after 1st visit | 30 days after 2nd visit | 45 day after 3rd visit
Weight
时间窗: 15 days after 1st visit | 30 days after 2nd visit | 45 day after 3rd visit
Waist/Hip
时间窗: 15 days after 1st visit | 30 days after 2nd visit | 45 day after 3rd visit
BMI
时间窗: 15 days after 1st visit | 30 days after 2nd visit | 45 day after 3rd visit
circumference
时间窗: 15 days after 1st visit | 30 days after 2nd visit | 45 day after 3rd visit
Mid-upper arm
时间窗: 15 days after 1st visit | 30 days after 2nd visit | 45 day after 3rd visit
次要结局
未报告次要终点
