This is a study to check effectiveness and safety of weight loss formulation in overweight and obese individuals when compared with a non active product.
- Conditions
- Health Condition 1: E65-E68- Overweight, obesity and other hyperalimentation
- Registration Number
- CTRI/2018/09/015580
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1 BMI (>=) greater than or equal to 29 Kg/m2 and less than or equal to (<=) 40 Kg/m2.
2 Willing to take up the walking exercise for a span of 30 minutes daily for 5 days in a week.
3 Subjects willing to go for DEXA analysis as per the scheduled visits during the study.
4 Subjects agree to maintain a diary on food consumption, Investigational Product Intake & daily exercise.
5 Willing to come for regular follow-up visits.
6 Able to give written informed consent.
1 Intake of over the counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous six months.
2 Pathophysiologic/genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Prader-Willi syndrome).
3 Alcoholics
4 Subjects with evidence of malignancy.
5 Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Pagets disease, joint fracture, acromegaly, fibromyalgia, Wilsons disease, ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
6 Subjects having history of coagulopathies, cardiovascular diseases, congestive heart failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness, peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD].
7 Subjects with HbA1c > 6.4 % and poorly controlled Diabetes Mellitus, poorly controlled Hypertension.
8 TSH > 10mIU/L and T3 and T4 higher than normal range.
9 Weight loss (±5%) in last 6 months.
10 Subjects on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
11 Subjects 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 for females or >1.4 mg/dL males of EGFR of 60 or more).
12 History of hypersensitivity to any of the herbal extracts or dietary supplement.
13 Pregnant or lactating woman.
14 Subjects who have completed participation in any other clinical trial during the last six 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 1Reduction in body weight and BMI. <br/ ><br>2Reduction in DEXA measurement. <br/ ><br>3Reduction in anthropometric measurements. <br/ ><br>4Changes in Lipid profile. <br/ ><br>5Change in obesity related serum biomarkers. <br/ ><br>6Improvement in Quality of life.Timepoint: 1Reduction in body weight and BMI(Visit1,Visit2,Visit3 and Visit4). <br/ ><br>2Reduction in DEXA measurement(Visit2 and Visit4). <br/ ><br>3Reduction in anthropometric measurements(Visit1,Visit2,Visit3 and Visit4). <br/ ><br>4Changes in Lipid profile(Visit1,Visit3 and Visit4). <br/ ><br>5Change in obesity related serum biomarkers(Visit2 and Visit4). <br/ ><br>6Improvement in Quality of life(Visit2,Visit3 and Visit4).
- Secondary Outcome Measures
Name Time Method 1Any reports of adverse or serious adverse events. <br/ ><br>2Abnormal vital signs. <br/ ><br>3Abnormal laboratory parameters.Timepoint: 1Any reports of adverse or serious adverse events(Visit3,Visit4 and follow up). <br/ ><br>2Abnormal vital signs (Visit1,Visit2,Visit3 and Visit4). <br/ ><br>3Abnormal laboratory parameters(Visit1,Visit3 and Visit4).