CTRI/2022/10/046429招募中不适用
A randomized, double blind, placebo controlled, parallel study to evaluate the efficacy and safety of YC-1102 on reducing of the body fat
Sangol Farm2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年10月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1) Change in body fat rate %
研究概览
简要总结
Fat accumulation is linked to muscle weakening and poor function and demonstrate worse physical performance. Maintaining a healthy body fat percentage can help reduce risk of various diseases and improve overall health. The rationale of this study is to evaluate the clinical efficacy and safety of YC-1102 tablet on reducing the body fat.
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
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female individuals aged from 19 to 60 (both inclusive) years
- •BMI between ≥ 25, <30 kg/m2
- •Participants who voluntarily agrees to participate and signs on informed consent form.
排除标准
- •Participants with a history of hypersensitivity to drugs, food ingredients, herbal extracts, or dietary supplements
- •Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months
- •Participants taking drugs or diet foods that affect their weight within 3 months prior to screening (absorption inhibitors, appetite suppressants, health functional foods/supplements related to obesity improvement, psychiatric drugs such as depression, diuretics, contraceptives, steroids, female hormones)
- •Participants with intentional weight loss of at least 5% within 3 months prior to screening
- •Participants who have undergone surgery, such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening
- •Endocrine diseases such as hypothyroidism and Cushing’s syndrome
- •Participants with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months (However, those who are clinically stable may participate in the trial at the investigator’ discretion)
- •Serious dysfunction of the liver (alanine and aspartate aminotransferase levels of 3.0 times the upper limit or normal) or kidney (creatinine > 2.0 mg/dL)
- •Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg)
- •Fasting blood glucose ≥ 126 mg/dL or random blood glucose ≥ 200 mg/dL, or diabetic patients taking oral hypoglycemic agents or insulin
- •Malignant tumor diagnosed within 3 years prior to screening
- •Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion
- •Participants with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse
- •Pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial
- •Participants with a history of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
- •Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion.
结局指标
主要结局
1) Change in body fat rate %
时间窗: Baseline and week 12
次要结局
- 6) Serum concentration measurements(✓ leptin)
- Other Evaluations(a) Dietary Record)
- 1) Change in physical measurement(✓ Weight)
- 2) Change in Body Mass Index (BMI)(Baseline, week 4, week 8, week 12)
- 3) Blood lipid concentration (Total-C, HDL-C, LDL-C, Triglyceride)(Baseline, week 4, week 8, week 12)
- 4) DEXA (Dual-Energy X-ray Absorptiometry)(✓ Body fat amount(g))
- 5) Abdominal fat CT (computed tomography) (between lumbar spine 4-5)(✓ visceral fat area,)
研究者
研究点 (2)
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