Clinical study of PR/HC/17-18/003 formulation in obese or overweight subjects.
- Conditions
- Health Condition 1: E669- Obesity, unspecified
- Registration Number
- CTRI/2019/06/019516
- Lead Sponsor
- Aayush Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Male and or female patients.
2 Age between 20 to 50 years.
3 BMI between 25 to 40 kg/m2.
4 Willing to come for regular follow-up visits.
5 Able to give written informed consent.
1 Intake of over the counter weight loss agents, centrally acting
appetite suppressants in the previous six months.
2 Pathophysiologic/ genetic syndromes associated with obesity
(Cushingâ??s syndrome, Turnerâ??s syndrome, Praderwilli syndrome).
3 Patients with evidence of malignancy.
4 Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%).
5 Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg).
6 Patients on prolonged ( > 6 weeks) medication with corticosteoids,
antidepressants, anticholinergics, etc. or any other drugs that may
have an influence on the outcome of the study.
7 Symptomatic patient with clinical evidence of Heart failure.
8 Patients with concurrent serious hepatic disorder (defined as
Aspartate Amino
Transferase (AST) and / or Alanine Amino Transferase (ALT), Total
Bilirubin,Alkaline Phosphatase (ALP) > 2 times upper normal limit) or
Renal Disorders (defined as S.Creatinine >1.2mg/dL), Severe
Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or
Chronic Obstructive Pulmonary Disease [COPD]), or any other
condition that may jeopardize the study.
9 History of HIV and other viral infections.
10 Alcoholics and/or drug abusers.
11 Prior surgical therapy for obesity.
12 History of hypersensitivity to any of the herbal extracts or dietary
supplement.
13 Pregnant / lactating woman.
14 Patients who have completed participation in any other clinical
trial during the past six (06) months.
15 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 Reduction of Body weight <br/ ><br>Reduction of BMI <br/ ><br>Improved anthropometric measurements (waist circumference, waist: hip ratio) <br/ ><br>Lipid profile <br/ ><br>Change in leptin & CRP level <br/ ><br>QOL Questionnaire <br/ ><br>Timepoint: Baseline, Day 30,Day 60 and Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Safety and Tolerability <br/ ><br>Adverse events (AEs), frequency and severity. <br/ ><br>Changes in the vital parameters <br/ ><br>Timepoint: Baseline, Day 30,Day 60 and Day 90