Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- physiological parameter for measuring Height and weight
研究概览
简要总结
Schizophrenia patients with anti-psychotics have decreased psychiatric symptoms, but have increased the generation of overweight or obesity. There is correlation between obesity, diabetes mellitus, metabolic syndrome, hypertension, hyperlipidemia and cardiovascular disorders. Cassia seed is one of traditional Chinese herbs, that can decline blood lipedema effect. Therefore, the purpose of the present study was to design a randomized, double blind, control group study to assess the therapeutic effect of Cassia seed in schizophrenia patients with obesity.
详细描述
Total of 92 schizophrenia patients with obesity will be enrolled and divided randomly into: 1) case group, received oral administration of Cassia seed (3.0g), once/day, 12 weeks; 2) control group, received oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia), 12 weeks. The primary outcome included the changes of body mass index (BMI), waist circumferences (WC); secondary outcome measured included the changes of hemoglobin A1c (HbA1c), total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, CRP (C-Reactive protein), IL-6, systolic blood pressure, diastolic blood pressure, and meridian energy.
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)
盲法说明
All participants are randomized into treatment or placebo group. Investigator also did not know who are in which group.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 to 65 years
- •diagnosed as schizophrenia at least more 6 months
- •no major systemic illnesses based on physical examinations and laboratory test results
- •BMI >= 24, WC >= 80 cm in female, WC >= 90 cm in male
排除标准
- •participants were pregnant and lactating women
- •allergy to Cassia
- •SGOT or SGPT more than 2 times normal level
- •BUN or creatinine more than normal level
- •Fasting blood glucose (serum) > 140 mg/dL, systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg, serum triglyceride > 400 mg/dL
研究组 & 干预措施
Cassia seed placebo
oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia) for 12 weeks
干预措施: cassia seed tablet (Drug)
Cassia seed
oral administration of Cassia seed (3.0g), once/day for 12 weeks
干预措施: cassia seed tablet (Drug)
结局指标
主要结局
physiological parameter for measuring Height and weight
时间窗: 12 weeks
the parameter of BMI in kg/m\^2 for exploring the changes of body mass index (BMI) after cassia obtusifolia treatment
sphygmomanometer
时间窗: 12 weeks
the parameter of systolic blood pressure and diastolic blood pressure after cassia obtusifolia treatment
次要结局
- Blood analyzer(12 weeks)
- Meridian energy skin conductivity assessment using amperometer (0-200uA)(12 weeks)
研究者
For-Wey Lung
superintendent
Calo Psychiatric Center