In this study the Lactospore and Forslean combination will be studied in comparison to an inactive in adult male or female patients suffering with metabolic syndrome.
- Conditions
- Health Condition 1: null- Adult male or female subjects diagnosed with metabolic syndrome.Health Condition 2: E889- Metabolic disorder, unspecified
- Registration Number
- CTRI/2017/03/008146
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1 Male and/or female patients.
2 Age between 18 to 65 years.
3 BMI between 30 to 34.9 Kg/m2
4 Willing to come for regular follow â??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 on prolonged ( >6weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
4 Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
5 Symptomatic patient with clinical evidence of Heart failure.
6 History of HIV and other viral infections.
7 Alcoholics and/or drug abusers.
8 Prior surgical therapy for obesity
9 H/o hypersensitivity to any of the trial drugs or their ingredients.
10 Pregnant / lactating woman.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Body weight and body mass index. <br/ ><br>â?¢Lipid Profile. <br/ ><br>â?¢Lab investigations. <br/ ><br>â?¢Gas and bloating, Stomach pain questionnaire. <br/ ><br>â?¢Gut health questionnaire.Timepoint: â?¢Body weight and body mass index (Screening, Day 45 & Day 90). <br/ ><br>â?¢Lipid Profile (Screening, Day 45 & Day 90). <br/ ><br>â?¢Lab investigations (Screening & Day 90). <br/ ><br>â?¢Gas and bloating, Stomach pain questionnaire (Day 0, Day 45 & Day 90). <br/ ><br>â?¢Gut health questionnaire (Day 0, Day 45 & Day 90).
- Secondary Outcome Measures
Name Time Method â?¢Quality of Life Questionnaire. <br/ ><br>â?¢Adverse events.Timepoint: â?¢Quality of Life Questionnaire(Day0,Day45 & Day90). <br/ ><br>â?¢Adverse events(Day45 & Day90).