Evaluation of efficacy and safety of CQ Extract in obese subjects – A Randomized, Double Blind, Multicenter, Placebo Controlled, Comparative, Interventional, Prospective, Clinical Study
Overview
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Nisarga Biotech Pvt Ltd
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in body weight in kg and other anthropometric measurements
Overview
Brief Summary
It is a randomized, double blind, multicenter, placebo controlled, comparative, interventional, prospective, clinical study to evaluate efficacy and safety of CQ Extract in obese subjects. The study will be carried out in two centers in India. The primary objective of the study will be to assess change in body weight (kg) and other anthropometric measurements. The secondary objectives of the study will be to assess change in lipid profile, change in general wellbeing on general wellbeing scale, changes in appetite, feeling of fullness, desire to eat, urge to eat, change in body shape, global assessment for overall change by investigator and by patient, tolerability of study products by assessing adverse events and change in laboratory parameters on Baseline visit, Day 30, Day 60, Day 90, Day 120
Summary of Results:
It can be concluded from the results of the study that CQ extract
showed significant reduction in body weight and BMI is healthy
obese participants. Sixteen weeks consumption of CQ extract
resulted in significant reduction in all the anthropometric
parameters including waist circumference, hip circumference,
Neck Circumference, Upper mid arm circumference and calf
circumference. Body fat percentage, lean body mass, total body
water content and basal metabolic rate were significantly reduced
with the use of CQ extrcat Safety assessment showed that CQ
extract was well tolerated by participants and there were no
significant changes in vital parameters and safety laboratory
investigations at the end of the study. No adverse effects were
reported with the use of CQ extract over a consumption period of
16 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 21.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •BMI greater than or equal to 25 Kg meter square and less than or equal to 34.9 Kg meter square
- •Willing to come for regular follow up visits.
Exclusion Criteria
- •Intake of over the counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous three months.
- •History of pathophysiologic, genetic syndromes associated with obesity Cushings syndrome, Turners syndrome, Prader Willi syndrome
- •Alcoholics and subjects with substance abuse
- •Subjects with known malignancy.
- •Subjects having history of coagulopathies, cardiovascular diseases, Asthma.
- •Subjects with Diabetes Mellitus, poorly controlled Hypertension.
- •TSH greater than 10mIU L and T3 and T4 higher than normal range.
- •Pregnant and lactating women
- •Subjects with hepatic and renal failure
- •Subjects on prolonged greater than 6 weeks medication with corticosteroids, antidepressants, anticholinergics, etc.
Outcomes
Primary Outcomes
Change in body weight in kg and other anthropometric measurements
Time Frame: Baseline visit, Day 30, Day 60, Day 90, Day 120
Secondary Outcomes
- 1. Change in Lipid profile(2. Change in general wellbeing on general wellbeing scale)
Investigators
Dr Vineet Kumar Malhotra
Vignaharta Health Care Clinic