To compare the effect of Phalatrikadi Kwath and Vrinda Triphaladi Kwath in obesity
- Conditions
- Obesity, unspecified, (2) ICD-10 Condition: E669||Obesity, unspecified, Patients of either sex between 21 to 51 yr with BMI ranging from 25.0 to 35 Kg/m2,
- Registration Number
- CTRI/2018/07/015075
- Lead Sponsor
- Chaudhary Brahm Prakash Ayurved Charak Sansthan
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
BMI ranging from 25.0 to 35 Kg/m2 Patients willing to participate and provide signed informed consent.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Weight 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 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 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 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 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi
🇮🇳Delhi, DELHI, India
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi🇮🇳Delhi, DELHI, IndiaProf Dr N R SinghPrincipal investigator9560659728naimishraj@yahoo.com