In this study the efficacy and safety of DigeZyme capsules will be studied in comparison to placebo in adult male or female patients suffering from Metabolic Health.
- Conditions
- Health Condition 1: null- Adult male or female patients suffering from Metabolic HealthHealth Condition 2: E889- Metabolic disorder, unspecified
- Registration Number
- CTRI/2016/11/007456
- 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-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 6 months.
2 Pathophysiologic/genetic syndromes associated with obesity.
3 Patients on prolonged 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.
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 1 Body weight and BMI. <br/ ><br>2 Lipid Profile. <br/ ><br>3 Stool Analysis. <br/ ><br>4 Gut Health Questionnaire.Timepoint: 1 Body weight and BMI(Screening,Day45 & Day90) <br/ ><br>2 Lipid Profile(Screening,Day45 & Day90) <br/ ><br>3 Stool Analysis(Screening & Day90) <br/ ><br>4 Gut Health Questionnaire(Day0,Day45 & Day90)
- Secondary Outcome Measures
Name Time Method 1 Quality of Life Questionnaire. <br/ ><br>2 Adverse Events.Timepoint: 1 Quality of Life Questionnaire(Day0,Day45 & Day90). <br/ ><br>2 Adverse Events(Day45 & Day90).