A Double Blind, Prospective, Randomised, Comparative, Placebo Controlled, Two Arm Study to Evaluate the Efficacy, Safety and Tolerability of Decrin Plus in Obesity Reduction and Weight Management in Adults.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 1.Anthropometric Changes: Reduction by ≥10% in Weight, BMI, Waist Circumference, Waist:Hip Ratio
研究概览
简要总结
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
-
- Anthropometric Measurements
-
- Laboratory Assessments(Lipid profile)
-
- Subject Self Assessment Questionnaire
-
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subjects between the ages of 21 and 65 years of age (both ages and sexes inclusive)
- •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)
- •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.
排除标准
- •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.
结局指标
主要结局
1.Anthropometric Changes: Reduction by ≥10% in Weight, BMI, Waist Circumference, Waist:Hip Ratio
时间窗: 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
时间窗: 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%
时间窗: 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
时间窗: 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
时间窗: 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%
时间窗: 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%
时间窗: 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
时间窗: 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
次要结局
- 1.Anthropometric Changes: Reduction by 5-9% in Weight, BMI, Waist Circumference, Waist:Hip Ratio(2.Lipid Levels:)