CTRI/2018/04/013224已完成3 期
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.
Solar Herbo Private Limited0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
相似试验
已完成
不适用
Clinical Study on Nichi Glucan to treat Diabetes with/without High Cholesterol and Lipid Levels.CTRI/2019/06/019855Enerflo Singapore Pvt Ltd157
尚未招募
3 期
Clinical Study on Collagen Capsules (Chicken) for Adults with Pain in Joints due to wear and tear (osteoarthritis)CTRI/2023/09/058043Titan Biotech Limited
已完成
不适用
Clinical Study to Evaluate the Efficacy of Collagen Peptide as an Add-on Nutritional Therapy in the Management of Diabetes Mellitus (Type II) in Adult Subjects.CTRI/2015/02/005518itta Gelatin India Limited60
进行中（未招募）
不适用
Clinical Study on Amore-Male Sexual Wellness Drink of Sipwise Beverages in Sexual Wellness in MalesCTRI/2021/04/032849Sipwise Beverages Private Limited
进行中（未招募）
不适用
Clinical Study on Amore-Female Sexual Wellness Drink of Sipwise Beverages in Sexual Wellness in Females.CTRI/2021/04/032884Sipwise Beverages Private Limited