A study to find the effect of Amla extract in obese people

Not Applicable

Completed

• Conditions: Health Condition 1: E669- Obesity, unspecified

• Registration Number: CTRI/2019/01/017201
• Lead Sponsor: Arjuna Natural Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

1. Subjects with BMI >= 35 kg/m2

2. Male subjects with waist circumference > 102 cm and female subjects with waist circumference > 88 cm.

3. Subjects with Triglycerides TG >= 200 mg/dL

4. Subjects with Total Cholestrol >= 200 mg/dL

5. Subjects who have provided signed informed consent for the trial.

Exclusion Criteria

1. Subjects with uncontrolled cardiovascular disease or advanced atherosclerosis (e.g. history of stroke, myocardial infarction, life- threatening arrhythmia, or coronary revascularization within the preceding 6 months; unstable angina; congestive heart failure; known or suspected clinically significant valvular heart disease or uncontrolled hypertension or use of antihypertensive medications, dose of which is not stable in the last one month) â?¨

2. Subjects with unstable diabetes, using insulin, glitazones, other hypoglycemic dose of which is not stable in last one month â?¨

3. Subjects with Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years).

4. Pregnancy, lactation and female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) â?¨

5. Subjects with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine>= 2.0 mg/dl) â?¨

6. Subjects with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures â?¨

7. Subjects with known history of hypersensitivity to amla or any product containing amla extract.

8. Subjects with history of alcohol intake daily or drug abuse.

9. Subjects with any other serious concurrent illness or malignancy. â?¨

10. Participation in another clinical trial in the past 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percent change in BMI, Waist circumference, Total body fat percentage, Visceral fat percentage at the end of 90 days.Timepoint: Day 0, Day 45, Day 90.

Secondary Outcome Measures

Name	Time	Method
1. Mean percent change in TG, TC, FBS at the end of 90 days. <br/ ><br>2. Mean percent change in Weight, Hip Circumference, Waist: Hip ratio at the end of 90 days. <br/ ><br>3. Mean percent change in Segmental subcutaneous fat percentage, Segmental skeletal muscle percentage at the end of 90 days. <br/ ><br>4. Mean change in Resting Metabolism at the end of 90 days. <br/ ><br>Timepoint: Day 0, Day 45, Day 90.;Other outcome: <br/ ><br>Mean change in Body Age and GPAQ â??Improvement in the mean MET score at the end of 90 days. <br/ ><br>Timepoint: Day 0, Day 45, Day 90