A comparative study to evaluate the efficacy of Phalatrikadi Kwatha and Vrinda-Triphaladi Kwatha in Sthaulya (Obesity).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in Weight
研究概览
简要总结
According to the inclusion and exclusion criteria patients will be randomly selected from OPD and IPD of Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar Najafgarh New Delhi
Informed written consent will be taken from all the subjects included in the study
Patients will be randomly divided into 2 groups of 20 patients each
In group A 20 patients will be given Phalatrikadi kwatha in dose of 40 ml after mixing 12 gm of haridra kalka and 12 ml of honey in it twice in a day empty stomach
in morning and four hour after lunch for 21 days
20 patients will be given Vrinda-Triphaladi kwatha in dose of 40 ml after mixing 12 gm of haridra kalka and 12 ml of honey in it twice in a day empty stomach in
morning and four hour after lunch for 21 days
A proforma will be prepared for diagnosis of disease and assessment of subjects
BMI Weight Waist circumference Hip Circumference Waist hip Ratio Subjective symptoms and Objective symptoms will be assessed before and after treatment and
during follow up
Lipid profile will be done before and after treatment
Assessment of abdominal discomfort and abdominal pain and will also be done 0 day 7th day 14th day and 21st day
All the patients will be advised to follow the guidelines regarding pathya-apathya as described in Classical Ayurvedic texts during the trial period
Data will be statistically analyzed at the end of the study period
All the ethical issues will be maintained during the clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI ranging from 25.0 to 35 Kg/m2 Patients willing to participate and provide signed informed consent.
排除标准
- •Patients with Hypothyroidism Patients suffering from drug induced Obesity Patients with Diabetes Patients with severe Hypertension Patients with Renal Hepatic and Cardiac involvement Pregnant and Lactating women Patients having Gastro intestinal discomfort Patients who are not willing to participate with the study 9.Any other condition which may jeopardize the study.
结局指标
主要结局
Reduction in Weight
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in BMI
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in Waist circumference
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in Hip circumference
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in Waist – Hip Ratio
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in Serum VLDL
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in Serum LDL
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in Serum Triglycerides
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in Serum Total Cholesterol and an increase in Serum HDL
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
Reduction in percentage relief in subjective criteria of Sthaulya
时间窗: Weight | BMI | Waist circumference | Hip circumference | Waist – Hip Ratio | subjective criteria of Sthaulya | on 0 day 21st day and 35th day | Serum VLDL | Serum LDL | Serum Triglycerides | Serum Total Cholesterol | Serum HDL | on 0 day and 21st day
次要结局
- Assessment of reduction in the level of abdominal discomfort pain and Frequency of defecation during use of trial medicines(level of abdominal discomfort pain and Frequency of defecation)