CTRI/2022/10/046429招募中未知
A randomized, double blind, placebo controlled, parallel study to evaluate the efficacy and safety of YC-1102 on reducing of the body fat
Sangol Farm0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female individuals aged from 19 to 60 (both inclusive) years
- •2. BMI between = 25, <30 kg/m2
- •3. Participants who voluntarily agrees to participate and signs on informed consent form
排除标准
- •1. Participants with a history of hypersensitivity to drugs, food ingredients, herbal extracts, or dietary supplements
- •2. Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months
- •3. 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)
- •4. Participants with intentional weight loss of at least 5% within 3 months prior to screening
- •5. Participants who have undergone surgery, such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening
- •6. Endocrine diseases such as hypothyroidism and Cushing’s syndrome
- •7. 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)
- •8. 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)
- •9. Uncontrolled hypertension (blood pressure = 160/100 mmHg)
- •10. Fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL, or diabetic patients taking oral hypoglycemic agents or insulin
- •11. Malignant tumor diagnosed within 3 years prior to screening
- •12. Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion
- •13. 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
- •14. Participants who are determined to be unable to exercise due to musculoskeletal disorders
- •15. Pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial
- •16. 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.
- •17. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion
研究者
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