Clinical study of CQ Extract in Obese subejcts

Evaluation of efficacy and safety of CQ Extract in obese subjects – A Randomized, Double Blind, Multicenter, Placebo Controlled, Comparative, Interventional, Prospective, Clinical Study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061102

Enrollment

Registered

2024-01-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E669- Obesity, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. BMI greater than or equal to 25 Kg meter square and less than or equal to 34.9 Kg meter square 2. Willing to come for regular follow up visits.

Exclusion criteria

Exclusion criteria: 1. 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, genetic syndromes associated with obesity Cushings syndrome, Turners syndrome, Prader Willi syndrome 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 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 greater than 6 weeks 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 in kg and other anthropometric measurementsTimepoint: Baseline visit, Day 30, Day 60, Day 90, Day 120	—

Secondary

Measure	Time frame
1. Change in Lipid profile 2. Change in general wellbeing on general wellbeing scale 3. Changes in appetite, feeling of fullness, desire to eat, urge to eat 4. Change in body shape 5. Global assessment for overall change by investigator and by patient 6. Tolerability of study products by assessing adverse events 7. Change in laboratory parameters Timepoint: Baseline visit, Day 30, Day 60, Day 90, Day 120	—

Measure

Time frame

1. Change in Lipid profile 2. Change in general wellbeing on general wellbeing scale 3. Changes in appetite, feeling of fullness, desire to eat, urge to eat 4. Change in body shape 5. Global assessment for overall change by investigator and by patient 6. Tolerability of study products by assessing adverse events 7. Change in laboratory parameters Timepoint: Baseline visit, Day 30, Day 60, Day 90, Day 120

—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd.

targetinstitute@yahoo.com09322522252

Outcome results