The Efficacy of Xian-Hua-Cha for Improving Hyperlipidemia Among Obese Population: a Crossover Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes on serum lipid profile
研究概览
简要总结
In the past decades, lipid and body fat disorders become a serious global healthcare issue, especially among the obese population. The aim of this study is to include 100 selected patients with BMI higher than 27 and hyperlipidemia, and a crossover design is used to explore the efficacy of "Xian-Hua-Cha (XHC)" on relieving hyperlipidemia among obese patient. For this purpose, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are analyzed in the end of this study.
详细描述
Recently, there are more and more studies show the natural herbal products can improve obesity and related metabolic disorders through changing the body composition and even body weight, but most of the studies are still at the phase of animal studies.
In the ancient Chinese medical book Danxi's mastery of medicine mentioned "Overweight people often have phlegm." From the past observational study, obesity is related phlegm, and the recent concept shows that obesity is a chronic inflammation disease. Therefore, we combined phlegm removal herbal medicine and Chinese medicine for clearing heat and detoxifying together for obese patients with lipid disorders in clinical practice. The aim of this study is to include 100 selected patients with BMI higher than 27 and hyperlipidemia, and a crossover design is used to analyze the efficacy of "Xian-Hua-Cha (XHC)" on relieving hyperlipidemia among the obese population. For this reason, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are collected for analysis. Besides, we also record adverse effects from taking XHC to assess the safety of XHC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
A number generated by random sequence before enrollment will be assigned to each subject to separate all subjects to two groups. Diet education/monitoring will be given with or without XHC depending the phase of trial course. Since XHC is a mixture of herbal products and difficult to make proper placebo, we adopt the crossover with open-label design in this study.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≧ 27kg/m2
- •Total cholesterol > 200 mg/dL or LDL > 130 mg/dL or triglyceride > 150 mg/dL
- •Age ≧ 20 years and < 75 years
- •No recognition difficulties
- •Willing to sign inform consent and comply to protocol
排除标准
- •Pregnant or breast-feeding women
- •Endocrine disorders (uncontrolled hypo/hyperthyroidism, adrenal gland disorder)
- •Diagnosis of neurologic or psychiatric diseases
- •Liver or renal dysfunction (AST/ALT higher than 3 times of upper normal limits; eGFR < 60 mL/min/1.73 m2)
- •Acute stress condition (severe infection, receive major surgery in the recent 1 month)
- •Vision, or hearing impairment
- •With other clinical trial medication
- •With medication for obesity or hyperlipidemia in the recent 1 month
- •Heavy smoker, alcoholism or substance abuse
- •Severe organ dysfunction: malignancies, autoimmune diseases
研究组 & 干预措施
Xian-Hua-Cha (XHC) group
Xian-Hua-Cha (XHC) 520 mL, twice a day will be given with diet education/monitoring program for this group for 3 months, followed by one-month wash-out period and a 3-month period with diet education/monitor program alone.
干预措施: Xian-Hua-Cha (Drug)
结局指标
主要结局
Changes on serum lipid profile
时间窗: 1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period)
The changes on serum triglyceride, total cholesterol, LDL (low-density lipoprotein) cholesterol, and HDL (high-density lipoprotein) cholesterol.
次要结局
- Changes on body weight(1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period))
- Changes on body fat composition(1-2 weeks before trial starting (day 0), 12 (first period), 16 (wash-out), and 28 week (second period))