Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: CQ Extract: Subjects will be asked to take 1 capsule (containing 500 mg CQ extract) twice daily orally with water for 60 days.
Control Intervention1: NIL: NIL
Sponsors
Nisarga Biotech Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. BMI greater than or equal to 25 and less than or equal to 34.9 2. Willing to come for regular follow-up visits.
Exclusion criteria
Exclusion criteria: Intake of over the counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous three months. 2. History of pathophysiologic or genetic syndromes associated with obesity 3. Alcoholics and subjects with substance abuse 4. Subjects with known malignancy. 5. Subjects having history of coagulopathies, cardiovascular diseases, Asthma. 6. Subjects with Diabetes Mellitus, poorly controlled Hypertension. 7. TSH greater than 10mIU per L and T3 and T4 higher than normal range. 8. Pregnant and lactating women 9. Subjects with hepatic and renal failure 10. Subjects on prolonged medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 11. Known hypersensitivity to any of the ingredients of CQ extract 12. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight (kg) & other anthropometric measurements (waist circumference, hip circumference, waist: hip ratio, body fat percentage, Basal Metabolic Rate (BMR), Total Body Water (TBW), Lean Body Mass (LBM), neck circumference, upper mid arm circumference, calf circumference)Timepoint: Baseline visit, Day 30 & Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Serum Leptin 2. Change in Lipid profile 3. Change in quality of life on WHO QOL BREF 4. Global assessment for overall change by investigator & by patient 5. Tolerability of study product by assessing adverse events/ adverse drug reactions 6. Laboratory investigations Timepoint: Baseline visit, Day 30 & Day 60 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed