The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
The goal of this research is hoping to combine traditional Chinese medicine medication and find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication compliance, improving life quality, improving social-function and reducing neopathy.
详细描述
Clozapine, an antipsychotic drug, is an important clinical medicine which is used for schizophrenia and preventing for its relapse; clozapine is better than some other atypical antipsychotics. However, in clinical uses, clozapine often could induce hypersalivation, it is not only influencing patient's appearance, also deteriorating sleeping quality which could deter patient discontinuing to take medicine.
In previous researches, Suo Quan Wan and Wu Lin San had been proven effective for hypersalivation and no significant side-effects, nevertheless, it still lack of systematical scientific trial reports. The ingredients of Suo Quan Wan are Wu Yao, San Yao and Yi Zhi Ren; the ingredients of Wu Lin San are Gui Zhi, Fu Ling, Zhu Ling, Ze Xie and Bai Ju, both have bi-directional regulatory functions for body fluid and saliva.
The goal of this research is hoping to combine traditional Chinese medicine medication and find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication compliance, improving life quality, improving social-function and reducing neopathy.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.20 year and older. All genders. 2.Psychiatry doctor diagnosed schizophrenia or schizoaffective disorder will be recruited for participation in this study.
- •3.Using clozapine as an antipsychotic drug and has a side-effect of hypersalivation.
- •4.Testee agree and sign informed consent forms to do this experiment.
排除标准
- •Use clozapine as an antipsychotic drug not over 8 weeks.
- •Testee have other diseases could influence saliva secretion, such as Parkinson's disease.
- •Pregnant, prepare to pregnant within half a year or in the lactation period.
- •Add or alter following medicines within 2 weeks:
- •4.1 Central acting 2-adrenergic receptor agonist 4.2 anticholinergic/antimuscarinic drugs 4.3 b-adrenoreceptor blockers, diphenhydramine, botulinum toxin injection
- •Testee's lever function test (AST/ALT) is higher than 3 (4 weeks medication).
- •Testee's kidney function test (Cr) is higher than 2.5mg/dl (4 weeks medication).
- •Testee have participate other medicine trial within one month.
研究组 & 干预措施
Placebo Comparator
干预措施: Placebo (Drug)
ChinesMed
干预措施: Suo Quan Wan, Wu Lin San (Drug)