CTRI/2025/02/080484尚未招募Phase 3 4
A Double Blind, Placebo-Controlled, Randomized, Clinical Study to Evaluate the Safety and Efficacy of Porelis on Weight Management in Overweight Subjects
Vidya Herbs Pvt Ltd,1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月24日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean change in the body weight, BMI and body fat composition
研究概览
简要总结
This is a double blind, placebo-controlled, randomized clinical trial. Adult overweight subjects meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms (1:1) to receive either Porelis or placebo for 12 weeks. Baseline blood samples will be collected for the laboratory assessments and safety assessments. Anthropometric measurements will be recorded. Body composition and fat distribution will be measured by DEXA. Subjects will be dispensed a subject diary and IP on Visit 2 and will be instructed to return for follow-up visits on Day 28, Day 56 and Day 84.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Overweight subjects: BMI greater of equal to 25.00 kg per meter sqaure and lesser of equal to 30 kg per meter square 2.Subject willing to adhere with their routine diet and exercise regimen throughout the study 3.Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4.Subjects willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Subjects having a change in body weight (gain or loss) of 5-10% or a loss of more than 5 kg within the last 3 months 2.Subjects with pathophysiologic or genetic syndromes associated with obesity 3.Intake of over the counterweight loss agents, centrally acting appetite suppressants in the previous six months 4.Subjects with a fasting blood sugar of grater or equal to 126 mg per dL, random blood sugar of greater or equal to 200 g per dL, or patients with diabetes taking oral hypoglycemic agents or insulin 5.Subjects suffering from any other chronic health conditions 6.Subjects allergic to herbal products or any component of the study product 7.Subjects with known HIV or Hepatitis B positive or any other immuno-compromised state 8.Subjects with history of Chronic metabolic disease,Psychiatric illness,Drug abuse, smoking, abuse or addiction to alcohol,Bariatric surgery,Eating disorder such as bulimia or binge eating,Endocrine abnormalities including stable thyroid disease,Cardiovascular surgery and History of any major surgery 9.Subjects currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 10.Subjects currently participating or having participated in obesity clinical trial during the last 6 months prior to the beginning of this study 11.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean change in the body weight, BMI and body fat composition
时间窗: Baseline, Day 28, Day 56 and Day 84
次要结局
- Mean change in biomarkers(Baseline, Day 28 and Day 84)
- Mean change in lipid profile(Baseline, Day 28 and Day 84)
- Mean change in anthropometric parameters(Baseline, Day 28, Day 56 and Day 84)
- Safety Assessment(Baseline, Day 28, Day 56 and Day 84)
研究者
Dr Shashank S Gowda
BGS Global Institute of Medical Sciences
研究点 (1)
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