A Clinical Trial To Study The Effect Of Ayurvedic Medication On Sthoulya (obesity)

Phase 2

• Conditions: Health Condition 1: E663- Overweight

• Registration Number: CTRI/2020/09/027508
• Lead Sponsor: ational Institute of Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects with LDL-C >= 130(mg/dl) at the time of screening.

2. Subjects with BMI >=24

3. Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.

Exclusion Criteria

1. Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II.

2. Subjects with uncontrolled Hypothyroidism or Hyperthyroidism

3. Known cases of Severe/Chronic Hepatic or Renal disease

4. Known subject of any active malignancy.

5. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.

6. Known case of Anorexia Nervosa or Bulimia nervosa

7. Chronic alcoholics / Alcohol Abuse

8. Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.

9. Subjects X- ray chest showing any active lesion of tuberculosis

10. Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.

11. Subjects using any other investigational drug within 1 month prior to recruitment

12. Known hypersensitivity to any of the ingredients used in study drug

13. Pregnant and Lactating females.

15. Subjects currently participating in any other Clinical study

16. Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigatorâ??s judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in LDL-C level at the end of study <br/ ><br>2.Change in body weight at the end of study <br/ ><br>Timepoint: Baseline, 6th Week, 12th Week

Secondary Outcome Measures

Name	Time	Method
1.Change in LDL-C level at 6 weeks <br/ ><br>2.Change in other lipid parameters such as Triglycerides (TG), Total Cholesterol (TC) and High Density Lipoprotein (HDL) at 6 weeks and 12 weeks. <br/ ><br>3.Change in Body Weight, BMI, Waist circumference and Waist to hip ratio at 6 weeks and 12 weeks. <br/ ><br>Timepoint: Baseline, 6th Week, 12th Week