Study to see the effect of Shred N Fit in obesity.
- Conditions
- Obesity, unspecified,
- Registration Number
- CTRI/2023/02/050109
- Lead Sponsor
- Gangwal Healthcare Pvt Ltd
- Brief Summary
The study is designed as Multicenter, double-blind, placebo-controlledstudy. Subject will be assigned to receive either Shred ‘N’ Fit or placebo.Parameters of anthropometric measurements and quality of life questionnaireswill be assessed over the period of 1 month. The study will enroll subjects ofage group 18 to 65 years.
A total of 112 cases will be enrolled in two groups(56 each group) with BMI between 25-34.9 Kg/m2.
Where one group will receive the regime of test drugShred ‘N’ Fit and other group will receive the regime of placebo. Safetyparameters like hematology and biochemistry will be assessed.
· Visit1 (Day -3): Screening Visit
· Visit2(Day 0): Randomization Visit
· Visit3(Day 15 ± 2): Follow up
· Visit4(Day 30 ± 2): EOT/Early termination
AE/SAE will berecorded during the conduct of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 112
- 1.Male and/or female volunteers aged between ≥18 to 65≥ years.
- 2.Subjects with BMI ≥ 25Kg/m2 and 34.9≥ kg/m2.
- 3.Subjects who are willing to do exercise for a span of 30 minutes daily for at least 5 days in a week.
- 4.Subjects who are willing to follow diet advised by investigator.
- 5.Subjects who are willing to give Inform consent.
- 6.Subjects who are willing to come for regular follow-up visits.
- 1.Subjects having intake of over-the-counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous three months or planning to undergo such surgery within 2 months.
- 2.History of pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, and Parder- Willi Syndrome).
- 3.Alcoholics and subjects with substance abuse.
- 4.Subject with evidence of malignancy.
- 5.Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget’s disease, joint fracture, acromegaly, fibromyalgia, rheumatoid arthritis.
- 6.Subjects having history of coagulopathies, cardiovascular diseases, asthma.
- 7.Pregnant and lactating women.
- 8.Subjects with hepatic and renal failure.
- 9.Subjects on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc.
- 10.Subjects with hypersensitivity to any one ingredient of the drugs.
- 11.Subjects who have participated in other trial within last 3 months.
- 12.Any other condition which the principal investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in body weight Baseline to week 4.
- Secondary Outcome Measures
Name Time Method 1.Change in anthropometric measurements 2.Change in lipid profile
Trial Locations
- Locations (3)
K R Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Moraya Multispecialty Hospital
🇮🇳Pune, MAHARASHTRA, India
Sunrise Multispeciality Hospital
🇮🇳Kolhapur, MAHARASHTRA, India
K R Hospital🇮🇳Nagpur, MAHARASHTRA, IndiaDrMadhu KumarRPrincipal investigator9743105248drkumarmadhu9@gmail.com