CTRI/2022/02/040052招募中不适用
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
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Body fat rate by DEXA (Dual-energy X-ray absorptiometry)
研究概览
简要总结
The rationale of the study is to evaluate the efficacy and safety of GGE03 on overweight subjects.
GGE03 is a steamed ginger extract powder which is obtained from Ginger. Ginger is known to have wide variety of medicinal benefits and contains powerful antioxidant, cytoprotective, digestive and antibacterial effects.
This trial is a reconduct of clinical trial registered with the number CTRI/2020/03/024216 with different time points.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteers of either sex, between 18 to 60 years (both inclusive) of age.
- •Volunteers of a body mass index (BMI), between 25.00 kg/m2 to 29.99 kg/m2(both inclusive).
- •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.
- •Endocrine diseases such as hypothyroidism, PCOD and Cushings syndrom.
- •9.Fasting blood glucose ≥ 126 mg/dL or random blood glucose ≥ 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.
结局指标
主要结局
1.Body fat rate by DEXA (Dual-energy X-ray absorptiometry)
时间窗: Baseline and 12 weeks
2.Body fat amount by DEXA (Dual-energy X-ray absorptiometry).
时间窗: Baseline and 12 weeks
次要结局
- 1.Weight(2.Waist Circumference)
研究者
研究点 (1)
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