NCT03251716已完成不适用
Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients
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
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change of FBG
研究概览
简要总结
In early clinical study investigators confirmed that berberine could prevent glucose and lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and safety of berberine in treatment for metabolic syndrome in schizophrenia.
详细描述
This study is an open lable clinical intervention trial, include 30 female subjects with diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine（ 300mgTID） as an add-on therapy lasting 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth Edition (DSM-5) ;
- •Female subjects aged 18-60 years;
- •monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine, clozapine, risperidone, and perphenazine；
- •subjects with diagnosis of metabolic syndrome depending on guidelines for the prevention and treatment of dyslipidemia in Chinese adults in 2007;
- •the subjects and their guardians sign the informed consent agreement.
排除标准
- •subjects with diagnosis of other psychiatric disorders except schizophrenia depend on DSM-5;
- •chronic organic diseases involving any central nervous system, such as tumors and inflammation, brain trauma, active seizures, vascular diseases, Parkinson's disease, myasthenia gravis, and other degenerative diseases;
- •a history of gastrointestinal surgery or the presence of any possibility of interfering with the absorption, distribution, metabolism, or excretion of drugs situation;
- •used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or receive transcranial magnetic stimulation therapy in the last 1 months;
- •serious physical diseases, including uncontrolled hypertension, severe cardiovascular, cerebrovascular, and pulmonary diseases, thyroid diseases, etc;
- •currently receiving anti-inflammatory or immunosuppressive treatment, including oral steroids;
- •a history of chronic infection, including tuberculosis, AIDS and hepatitis;
- •allergic to berberine,or hemolytic anemia or glucose -6- phosphate dehydrogenase deficiency;
- •pregnant women, lactating women；
- •participants were involved in other clinical trials within 1 months prior to the signing of informed consent
- •other reasons judged by the researchers to be inappropriate for the clinical study.
研究组 & 干预措施
berberine adjunctive group
Experimental
Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group
干预措施: berberine (Drug)
结局指标
主要结局
Change of FBG
时间窗: Change from Baseline serum fasting biood glucose at 8 weeks
Serum fasting biood glucose
次要结局
- Change of TG(Change from Baseline serum triglyceride at 8 weeks)
- Change of LDL(Change from Baseline serum low density lipoprotein at 8 weeks)
- Change of waist(Change from Baseline waistline at 8 weeks)
- Change of BP(Change from Baseline Diastolic Blood Pressure at 8 weeks)
研究者
研究点 (1)
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