A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Cardiovascular Effects, Safety and Tolerability of Investigational Product (NS2129E03) in Overweight Subjects.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change in Lipid Profile and Biomarkers as compared to placebo from baseline to end of the study.
研究概览
简要总结
This is a double blind, placebo-controlled, randomized, parallel-group study. 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 (50:50) to receive either NS2129E03 or placebo, orally, once a day for 84 days. Biomarkers and Lipid profile will be analysed. Anthropometric measurements will be recorded in every visit. All efficacy and safety assessment blood sample collection and anthropometric measurements will be conducted at all the visits.
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
- •Overweight Subject: BMI greater or equal to 25.00 to less than 30 kg/m2.2)Subject willing to adhere with their routine diet and exercise regimen throughout the study.3)Subjects not undergoing any supplementation for weight management.4)Females of childbearing age, who agree to use approved birth control methods during the study and have negative UPT at screening.5)Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Subjects suffering from intractable obesity, had defined weight limits, or had experienced any recent, unexplained weight loss or gain six months prior to screening.2)Pathophysiologic/genetic syndromes associated with obesity.3)Intake of over the counterweight loss agents, centrally acting appetite suppressants in the previous six months.4)Subjects suffering from any chronic health conditions.5)Subjects allergic to herbal products or any component of the study product.6)Known HIV or Hepatitis B positive or any other immuno-compromised state.7)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.8)Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.9)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 Lipid Profile and Biomarkers as compared to placebo from baseline to end of the study.
时间窗: Baseline, Day 42, Day 84
次要结局
- Mean Change in Body Composition and related parameters(Baseline, Day 42, Day 84)
- Overall Safety(Baseline, Day 42, Day 84)
研究者
Dr Harshith C S
BGS Global Institute of Medical Sciences