Clinical Study on Decrin Plus for Weight Reduction and Management
- Conditions
- Obesity due to excess calories,
- Registration Number
- CTRI/2018/04/013224
- Lead Sponsor
- Solar Herbo Private Limited
- Brief Summary
**StudyDesign**: A Double Blind, Prospective, Randomized,Comparative, Parallel Group, Placebo Controlled, Two Arm Clinical Study Trial
**StudyPopulation:** Adults between 21 and 65 years of age with BMI≥ 30Kg/m2.(both ages and sexes inclusive)
**Indication:** Obesity/weight Management
- Investigational Product – **Test** : Decrin plus
- Investigational Product – **Comparator :** Placebo.
**Study Duration :**3 months
**Number of Subjects** : 42 Subjects (To reach 36evaluable subjects)
- Two Treatment Arms (2:1 Ratio)
- Treatment Arm I – Decrin Plus– 28 Subjects
- Treatment Arm II – Placebo – 14 Subjects.
**Assessments**
- 1. Anthropometric Measurements
- 2. Laboratory Assessments(Lipid profile)
- 3. Subject Self Assessment Questionnaire
- 4. Subject IP Feed Back Questionnaire
**StudyResults**
**WeightReduction:** Thedata analysed confirms that 100% subjects in Decrin Plus group have achieved atleast 10% reduction in Weight by end of study; while compared to 0% subjects inPlacebo group. (Z = 6.00, p < 0.05).
**Reductionin BMI:** Thedata analysed confirms that 96% of the subjects in Decrin Plus group haveachieved at least 10% reduction in BMI by end of study; while compared to 0%subjects in Placebo group (Z = 5.63, p < 0.05)
**Reductionin Waist Circumference:** The data analysed confirms that 100% of the subjectsin Decrin Plus group have achieved at least 10% reduction in WaistCircumference by end of study; while compared to 0% subjects in Placebo group(Z = 6.00, p < 0.05).
**Reductionin Waist:Hip Ratio:** The data analysed confirms that 80% of the subjects inDecrin Plus group have achieved at least 10% reduction in Waist : Hip Ratio byend of study; while compared to 0% subjects in Placebo group (Z = 4.45, p <0.05).
**SafetyResults:** No adverse event was reported by any subject enrolledinto the study.
**StudyConclusion:**Overall, it is concluded that Decrin Plus was veryeffective in significantly reducing Weight, BMI, Waist Circumference and Wasit:Hip Ratio. 100% of the subjects who tookDecrin Plus assessed it to be effective in reducing their weight and improvingtheir quality of life. There was noadverse events recorded upon the consumption of Decrin Plus.
**Decrin Plus is recommended as a safe and effectivetherapy for Weight Reduction and Obesity Management in Adults.**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
- 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.
- Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
- Subjects with known hypersensitivity to herbal investigational product or its constituents.
- Subjects with secondary obesity.
- Subjects who have previously undergone surgery for the treatment of obesity not limited to liposuction, bariatric surgery etc.
- Subjects with history of eating disorders.
- Subjects with untreated or uncontrolled hypothyroidism.
- Subjects who are currently on concomitant medications that may contribute to significant weight gain or weight loss.
- Subjects with history of Acute Coronary syndrome, myocardial infarction, stroke, arrhythmia or atrial fibrillation in the past 1 year.
- Subjects with poorly controlled hypertension.
- Subjects with immune compromised state complications.
- Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
- 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.
- Females who are pregnant or lactating or planning to become pregnant during the study period.
- Females who have given birth or undergone a miscarriage in the past 1 year.
- Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- 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 ≥10% in Weight, BMI, Waist Circumference, Waist:Hip Ratio 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 | 2. Lipid Level: Day1, Day 45 and Day 90. | 3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 | 4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 c.HDL: ≤60mg/dL 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 | 2. Lipid Level: Day1, Day 45 and Day 90. | 3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 | 4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 d.Triglycerides: Reduction of 10% 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 | 2. Lipid Level: Day1, Day 45 and Day 90. | 3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 | 4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 4.Subject IP Feedback Questionnaire: Score of ≥20 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 | 2. Lipid Level: Day1, Day 45 and Day 90. | 3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 | 4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 2.Lipid Levels:s 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 | 2. Lipid Level: Day1, Day 45 and Day 90. | 3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 | 4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 a.LDL: Reduction of 10% 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 | 2. Lipid Level: Day1, Day 45 and Day 90. | 3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 | 4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 b.Total Cholesterol: Reduction of 10% 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 | 2. Lipid Level: Day1, Day 45 and Day 90. | 3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 | 4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 3.Subject Self Assessment Questionnaire: Score of ≥20 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90 | 2. Lipid Level: Day1, Day 45 and Day 90. | 3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90 | 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 2.Lipid Levels:
Trial Locations
- Locations (1)
Raam Clinic
🇮🇳Chennai, TAMIL NADU, India
Raam Clinic🇮🇳Chennai, TAMIL NADU, IndiaDr VT SriraamPrincipal investigator9840909155md@auroushealthcare.com