A randomised placebo-controlled clinical study to assess the safety and tolerability of Capsifen and its efficacy on energy expenditure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Energy Expenditure in comparison with baseline values
研究概览
简要总结
This is a randomised placebo-controlled clinicalstudy. Healthy male and femalevolunteers with age between 21- 40 and BMI between 27kg/m to 40kh/m will be enrolled in the study. All thevolunteers should have practicing some kind of exercise at least for the lastone month to manage the obesity or weight. This study will include four visits(Screening, Day 0, Day 28 and Day 56). During the screening, inclusionexclusion criteria for the subject are evaluated. All the safety and efficacyparameters values are collected before dispensing the investigational productto the volunteer’s on day 0 and that will consider as the Baseline value.Energy expenditure will be calculated by indirect colorimetric method. Subjectsare requested to come 12 hours fasting for the indirect colorimetricassessment. All the volunteers are requested to consume a single dose ofplacebo or Capsifen (200mg) for a period of 56 days. Safety analysis will beperformed on day 28 and day 56 and all the efficacy parameters will beevaluated at the end of the study (Day 56 ). The safety and efficacy ofcapsifen will be established by comparison of day 56 values with baselinevalues
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 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female healthy volunteers who have been practicing exercise or training sessions for a minimum period of last 1 month to manage the obesity 2)Age 21-40 Years ( Both Inclusive) 3)Subjects with Body Mass Index (BMI) between 27Kg/m to 40 Kg/m 4)Shall agree to sign an Informed Consent Document.
排除标准
- •Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic, gastrointestinal problems, and renal problems 2)Subjects with a history of anorexia nevosa or other eating disorders 3)Subjects with known history of gastrointestinal irregularities 4)Prior use of anti obesity agents 5)History of surgical therapy for obesity 6)Subjects with known genetical syndromes which cause obesity 7)Subjects who are currently under any kind of long term medication 8)Subjects with a known allergy to herbal products 9)Subjects with abnormal biochemical or haematological values 10)Pregnant or Lactating Women 11)Any condition that in Opinion of the Investigator, does not justify the Subjects’ participation in the study.
结局指标
主要结局
Change in Energy Expenditure in comparison with baseline values
时间窗: Day 0, Day 56
次要结局
- Tolerabily, safety and adverse event assessment(Day 0, Day 28, Day 56)
- Change in Biochemical Markers in comparison with basline values(Day 0, Day 56)