CTRI/2022/02/040052招募中未知
A prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GGE03 on overweight subjects.
试验速览
- 阶段
- 未知
- 状态
- 招募中
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. Volunteers of either sex, between 18 to 60 years (both inclusive) of age.
- •2. Volunteers of a body mass index (BMI), between 25.00 kg/m2 to 29.99 kg/m2(both inclusive).
- •3. Subjects who agree the participation in the trial and submit informed consent before the beginning of the trial.
排除标准
- •1.Known history of hypersensitivity to herbal extracts or dietary supplements.
- •2.Participated in a commercial weight loss program or clinical trial for obesity/overweight within the last three months.
- •3.Intentional weight loss of at least 5% within 3 months prior to screening.
- •4.Any history of surgery such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening.
- •5.Consuming drugs or diet foods that affect their weight within 3 months prior to screening.
- •6.Psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse.
- •7.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.
- •8. Endocrine diseases such as hypothyroidism, PCOD and Cushings syndrom.
- •9.Fasting blood glucose ââ?°Â¥ 126 mg/dL or random blood glucose ââ?°Â¥ 200 mg/dL, or diabetic patients taking oral hypoglycaemic agents or insulin.
- •10.Serious dysfunction of liver (alanine and aspartate aminotransferase levels of 2.5 times the upper limit or normal) or kidney (creatinine > 2.0 mg/dL).
- •11.Signs or symptoms of severe gastrointestinal symptoms such as heartburn and indigestion.
- •12.Use of drugs (absorbent laxatives and appetite suppressants, health function foods/supplements related to obesity improvement, psychotropic drugs such as anti-depressants, beta-blockers, diuretics, contraceptives, steroids and female hormones) that affect his or her body weight in the last one month or less.
- •13.Unable to exercise due to musculoskeletal disease.
- •14.A female who is breastfeeding or pregnant or planning for pregnancy during this study period.
- •15.Subject judged as unfit for study by PI.
研究者
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