Clinical Study on Decrin Plus for Weight Reduction and Management
- Conditions
- Health Condition 1: E660- Obesity due to excess calories
- Registration Number
- CTRI/2018/04/013224
- Lead Sponsor
- Solar Herbo Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1. Adult subjects between the ages of 21 and 65 years of age (both ages and sexes inclusive)
2. Subjects with BMI >=30 kg/m2 and/or elevated lipid levels at the time of screening. (Subjects with elevated lipid levels to be considered as a separate cohort)
3. Subjects with normal gastrointestinal digestion and absorption.
4. Subjects who are non-alcoholic & non-smokers or have maintained complete abstinence for 2 months prior to screening and willing to abstain until end of treatment duration.
5. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
1. Subjects with known hypersensitivity to herbal investigational product or its constituents.
2. Subjects with secondary obesity.
3. Subjects who have previously undergone surgery for the treatment of obesity not limited to liposuction, bariatric surgery etc.
4. Subjects with history of eating disorders.
5. Subjects with untreated or uncontrolled hypothyroidism.
6. Subjects who are currently on concomitant medications that may contribute to significant weight gain or weight loss.
7. Subjects with history of Acute Coronary syndrome, myocardial infarction, stroke, arrhythmia or atrial fibrillation in the past 1 year.
8. Subjects with poorly controlled hypertension.
9. Subjects with immune compromised state complications.
10. Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
11. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
12. Females who are pregnant or lactating or planning to become pregnant during the study period.
13. Females who have given birth or undergone a miscarriage in the past 1 year.
14. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
15. Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Anthropometric Changes: Reduction by â?¥10% in Weight, BMI, Waist Circumference, Waist:Hip Ratio <br/ ><br>2.Lipid Levels:s <br/ ><br>a.LDL: Reduction of 10% <br/ ><br>b.Total Cholesterol: Reduction of 10% <br/ ><br>c.HDL: â?¤60mg/dL <br/ ><br>d.Triglycerides: Reduction of 10% <br/ ><br>3.Subject Self Assessment Questionnaire: Score of â?¥20 <br/ ><br>4.Subject IP Feedback Questionnaire: Score of â?¥20Timepoint: 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 <br/ ><br>2. Lipid Level: Day1, Day 45 and Day 90. <br/ ><br>3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 <br/ ><br>4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90
- Secondary Outcome Measures
Name Time Method 1.Anthropometric Changes: Reduction by 5-9% in Weight, BMI, Waist Circumference, Waist:Hip Ratio <br/ ><br>2.Lipid Levels: <br/ ><br>a.LDL: Reduction of 5-9% <br/ ><br>b.Total Cholesterol: Reduction of 5-9% <br/ ><br>c.HDL: 40-49 mg/dL <br/ ><br>d.Triglycerides: Reduction of 5-9% <br/ ><br>3.Subject Self Assessment Questionnaire: Score of 15-19 <br/ ><br>4.Subject IP Feedback Questionnaire: Score of 15-19Timepoint: 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 <br/ ><br>2. Lipid Level: Day1, Day 45 and Day 90. <br/ ><br>3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 <br/ ><br>4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90