A randomized, double-blind, placebo-controlled, parallel-group, clinical study to evaluate efficacy and safety of RoseFit on weight management in overweight subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes in body weight and BMI from baseline to end of the study (EOS)
研究概览
简要总结
This is a double blind, randomized (1:1),placebo controlled, parallel group, two arm study. Overweight subjects meetingall inclusion and no exclusion criteria, after signing a written informedconsent will be enrolled in the study. After passing the eligibility criteria,subjects will be randomized into 2 treatment arms (50:50) to receive eitherRoseFit or placebo, orally, twice a day before meals (breakfast anddinner).
The subject will arrive at the study sitein a fasted state and blood samples will be collected for laboratory assessmentand safety assessment), The study will be conducted in 4 visits over a period of12 weeks. There will be a follow up visit at the end of Week 14.
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
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Overweight Subject: BMI ≥ 25.00 to < 30 kg/m2 2.Subject willing to adhere with their routine diet and exercise regimen throughout the study 3.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1Subjects suffering from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain six months prior to screening.
- •2Pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader–Willi syndrome).
- •3Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months 4Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease); 5Subjects allergic to herbal products or any component of the study product 6Known HIV or Hepatitis B positive or any other immuno-compromised state 7History of Chronic metabolic disease, Psychiatric illness,Drug abuse, smoking abuse/addiction to alcohol, Bariatric surgery Eating disorder such as bulimia or binge eating Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery, History of any major surgery 8Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9Any 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
Changes in body weight and BMI from baseline to end of the study (EOS)
时间窗: Day 0, Day 28, Day 56, Day 84
Change in body composition and fat distribution (assessed by DEXA) from baseline to EOS-body fat % and lean mass/fat mass ratio
时间窗: Day 0, Day 28, Day 56, Day 84
次要结局
- Changes in Appetite biomarkers ,Visual Analog Scale Scores (VAS) for appetite ,Lipid profile and OGTT levels from baseline to EOS(Day 0, Day 28, Day 56, Day 84)