NCT03479346已完成不适用
Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With or Without Metabolic Syndrome Risk Factors - A Study Protocol for a Double-blind, Randomised, Multi-center, Placebo-controlled Clinical Trial
Gachon University Gil Oriental Medical Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年4月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Changes from baseline in body weight
研究概览
简要总结
The Purpose of this trial is to investigate the efficacy and safety of GGT on Korean obese Women with or without metabolic syndrome Risk factors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 19 to 65 years
- •Subject must included at least one or more of the following symptoms below;
- •BMI of 30 kg/㎡ or more;
- •BMI between 27 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit
- •BMI between 27 and 29.9kg/㎡ with hyperlipidemia, taking medication or total cholesterol ≥ 200mg/dL or Triglyceride ≥ 150mg/dL at screening visit
- •Agreed to low-calorie diet during the trial
- •Written informed consent of the trial
排除标准
- •Subjects who had experience with allergic reaction on investigational drug(any ingredients of IP)
- •Subjects who has diabetes as comorbidity, had experienced the elevation of blood glucose by ephedrine
- •Subjects who had experienced rash, rubefaction, or itchiness by GGT administration
- •Subjects who usually feel fatigue due to hyperhidrosis
- •Subjects who experienced other allergic reactions
- •Subjects who had 10 percent reduction in body weight over 6 months
- •Subjects who decided to quit smoking over the last 3 months or have irregular smoking habits
- •Subjects who have endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc.
- •Subjects who have heart disease (heart failure, angina pectoris, myocardial infarction)
- •Subjects who have uncontrolled hypertension despite the use of antihypertensive drugs (SBP > 145 mmHg or DBP > 95 mmHg)
- •Subjects who have uncontrolled diabetes despite the use of drugs (FBS>7.8 mmol/L (140 mg/dL))
- •Subjects who have severe renal disability (SCr > 2.0 mg/dL)
- •Subjects who have severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase [ALP])
- •Subjects who have poor digestion(anorexia, stomach discomfort, nausea, vomiting etc) or have the history of eating disorder such as anorexia nervosa or bulimia nervosa, etc.(KEAT-26 < 20)
- •Use of medication that can affect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medications can affect on absorption, metabolism, excretion)
- •Use of CNS stimulant medication for weight loss
- •Subjects who had a use of drugs that can increase blood pressure or heart rate within a week, such as, Decongestants, cough, cold, allergy treatments that include the ingredients of phenylpropanolamine, ephedrine, pseudoephedrine
- •Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
- •Subjects who have diseases that may occur hypokalemia (hypomagnesemia, Bartter syndrome, Gitelman syndrome, diseases that can cause high aldosteronism etc.) or have cardiac dysrhythmia
- •Difficult to measure anthropometric dimensions because of anatomical change such as resection
- •History of weight loss surgery, such as bariatric surgery, etc.
- •Edema or dysuria
- •Malignant tumour or lung disease
- •Cholelithiasis
- •History of narrow angle glaucoma
- •Subjects who have nervous or psychological medical history or presently suffer from the following diseases: depression, manic disorder, bipolar disorder, schizophrenia, epilepsy, alcoholism, anorexia, hyperphagia, etc.
- •Subjects who have history of stroke or temporary ischemic cardioplegia
- •Subjects who are judged to be inappropriate for the clinical study by the researchers
- •Women who were pregnant, lactating or have the chances of pregnancy who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.)
- •Use of other investigational product within last 1 month
研究组 & 干预措施
GGT group
Experimental
Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
干预措施: GGT (Drug)
Placebo group
Placebo Comparator
Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in body weight
时间窗: baseline, 12 weeks
Estimated mean changes from baseline in body weight after 12 weeks of treatment.
次要结局
- Economic evaluation (medical costs)(baseline, 4,8,12,16,20,24 weeks)
- Changes from baseline in Waist circumference(baseline, 4,8,12 weeks)
- Changes from baseline in C-reactive protein (CRP)(baseline, 12 weeks)
- Changes from baseline in blood glucose(Screening visit, 12 weeks)
- Korean version of Western Ontario and McMasters Universities Oateoarthritis Index(baseline, 12, 16 weeks)
- Economic evaluation (time-related costs)(baseline, 4,8,12,16,20,24 weeks)
- Changes from baseline in body fat percentage(baseline, 4,8,12 weeks)
- Changes from baseline in Waist/hip ratio(baseline, 4,8,12 weeks)
- European Quality of life 5 Dimension(EQ5D)(baseline, 12 weeks)
- Changes from baseline in Body mass index(baseline, 4,8,12 weeks)
- Changes from baseline in fat mass(baseline, 4,8,12 weeks)
- Changes from baseline in Lipid profile(Screening visit, 12 weeks)
- Changes from baseline in serum leptin(baseline, 12 weeks)
- cost per QALY(Quality Adjusted Life Years) gained(6 months or 1 year)
- Economic evaluation (lost productivity costs)(baseline, 4,8,12,16,20,24 weeks)
研究者
Yun-Kyung Song
Principal investigator
Gachon University Gil Oriental Medical Hospital
研究点 (1)
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