ITMCTR2000003944尚未招募1 期
Clinical study based on intestinal flora on the treatment of Xiexin Decoction on Metabolic syndrome caused by Olanzapine
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65(—)
- 性别
- All
入选标准
- •1. Meet the diagnostic criteria of the International Classification of Diseases (ICD-10) for schizophrenia; It conforms to the syndrome differentiation and treatment of hyperpyremia of stomach in traditional Chinese medicine.
- •2. Patients should take olanzapine and the dose should reach the minimum therapeutic dose of olanzapine or above;
- •3. Meet the clinical diagnostic criteria of metabolic syndrome of the Diabetes Branch of the Chinese Medical Association. According to the diagnostic criteria proposed by the Chinese Diabetes Association in 2017, the given metabolic signs can be diagnosed if they have 3 or more of the following 5 components:
- •(1) Abdominal obesity (i.e. central obesity) : waist circumference >= 90cm for men and >= 85cm for women;
- •(2) Hyperglycemia: fasting blood glucose >= 6.1mmol/L or 2h blood glucose >= 7.8mmol/L after glucose load and/or diabetes has been confirmed and treated;
- •(3) Hypertension: blood pressure >= 130/85mmhg and/or has been confirmed as hypertension and treatment;
- •(4) on an empty stomach TG acuity 1.7 mmon/L;
- •(5) on an empty stomach HDL - C < 1.04 tendency/L.
- •4. Regardless of gender, age 18-65 years;
- •5. An informed consent to participate in the study shall be provided and signed by the subject himself or his legal guardian.
排除标准
- •1. Serious physical diseases, organic brain diseases, craniocerebral trauma, etc.;
- •2. Complicated with acute infection.
- •3. Patients with acute complications such as diabetic ketoacidosis or accompanied by other cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction and cerebral hemorrhage).
- •4. Patients with severe primary liver and kidney diseases, psychiatric patients, pregnant or lactating women, and those who are allergic to this drug.
- •5. Blood pressure > 160/95mmhg.
- •6. Exclude patients who meet the diagnostic criteria of the International Classification of Diseases (ICD-10) for alcohol and drug dependence and intellectual impairment;
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