Efficacy and safety of Lekhan Basti and Navak Guggul in Sthaulya (Obesity) using biochemical and genetic markers
- Conditions
- Health Condition 1: E668- Other obesity
- Registration Number
- CTRI/2019/02/017426
- Lead Sponsor
- TN Medical College BYL Nair Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. BMI: Between 28-32.9 / Grade I obesity
2. Waist-Hip Ratio greater than the normal reference range as per WHO (Men > 0.90 and Women > 0.85)
1.Patients with Grade II/Grade III obesity (BMI score between 33 to 38 or >38)
2.Patients with past history of major cardiac conditions like acute coronary syndrome, Myocardial Infarction, cardiac arrhythmias and/or cardiac failure in the last 6 months
3.Patients with severe &/or uncontrolled medical conditions like Diabetes mellitus (FBS > 200mg/dl) and hypertension (BP >160/100 mm Hg), endocrine disorders (Hyperthyroidism, hypothyroidism, Cushingâ??s syndrome), malignancies and/or any other clinically significant medical condition, which the investigator believes, will contraindicate his/her inclusion in the study.
4.Patients with history of Immuno-compromised status (HIV, Hepatitis B & C etc.)
5.Patients with any ano-rectal conditions like bleeding piles, fistula, fissure etc.
6.Those receiving any other concomitant drugs that could confound the efficacy evaluation.
7.Pregnant and/or lactating women
8.Alcoholics and/or drug abusers.
9.Any other condition which the Study Investigators think may jeopardize the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in body weight among 4 study groups at the end of treatment. <br/ ><br>2.Change in anthropometric measurements among 4 study groups at the end of treatmentTimepoint: Day 0, Day 45,Day 90, Day 135, Day 165 and Day 195
- Secondary Outcome Measures
Name Time Method 1.Change in the Ayurvedic symptom score among 4 study groups at the end of treatment. <br/ ><br>2.Change in the biochemical markers among 4 study groups at the end of treatment. <br/ ><br>3.Change in the genetic markers among 4 study groups at the end of treatment. <br/ ><br>4.Change in the Quality of Life score among 4 study groups at the end of treatmentTimepoint: Day 0, Day 135 and Day 195