The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Clozapine Hypersalivation Traditional Chinese Medicine |
Drug: Suo Quan Wan, Wu Lin San Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient. |
| Estimated Enrollment: | 45 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo Comparator |
Drug: Placebo
Placebo (starch)
|
| Experimental: ChinesMed |
Drug: Suo Quan Wan, Wu Lin San
Suo Quan Wan Wu Lin San Placebo 2/daily
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Tsuo-Hung Lan, MD., PhD. | 04-23592525 ext 3460 | tosafish@hotmail.com |
| Contact: Chia-Chun Hung, MD. | 04-23592525 ext 3404 | cocohung0418@gmail.com |
| Taiwan | |
| Taichung Veterans General Hospital | Recruiting |
| Taichung City, Taiwan, 40705 | |
| Contact: Tsuo-Hung Lan, MD., PhD. 886-4-23592525 ext 3460 tosafish@hotmail.com | |
| Sub-Investigator: Chia-Chun Hung, MD. | |
| Study Director: | Tsuo-Hung Lan, MD., PhD. | Taichung Veterans General Hospital |
| Study Director: | Tsuo-Hung Lan, MD.,PhD | Taichung Veterans General Hospital |
More Information
No publications provided by Taichung Veterans General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | IRB TCVGH, Taichung Veterans General Hospital |
| ClinicalTrials.gov Identifier: | NCT01045720 History of Changes |
| Other Study ID Numbers: | C08200 |
| Study First Received: | January 5, 2010 |
| Last Updated: | January 13, 2010 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Taichung Veterans General Hospital:
|
Schizophrenia clozapine hypersalivation Suo Quan Wan Wu Lin San |
Additional relevant MeSH terms:
|
Salivary Gland Diseases Schizophrenia Sialorrhea Schizophrenia and Disorders with Psychotic Features Mental Disorders Mouth Diseases Stomatognathic Diseases Clozapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents |
ClinicalTrials.gov processed this record on May 21, 2013