The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia
The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 schizophrenia
Started Jan 2010
Shorter than P25 for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJanuary 14, 2010
January 1, 2010
2 months
January 5, 2010
January 13, 2010
Conditions
Keywords
Study Arms (2)
Placebo Comparator
PLACEBO COMPARATORChinesMed
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- year and older. All genders. 2.Psychiatry doctor diagnosed schizophrenia or schizoaffective disorder will be recruited for participation in this study.
- Using clozapine as an antipsychotic drug and has a side-effect of hypersalivation.
- Testee agree and sign informed consent forms to do this experiment.
You may not qualify if:
- 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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taichung Veterans General Hospital
Taichung, Taiwan, 40705, Taiwan
Related Publications (1)
Hung CC, Fu PK, Wang HY, Chan CH, Lan TH. Treatment effects of traditional Chinese medicines Suoquan Pill and Wuling Powder on clozapine-induced hypersalivation in patients with schizophrenia: study protocol of a randomized, placebo-controlled trial. Zhong Xi Yi Jie He Xue Bao. 2011 May;9(5):495-502.
PMID: 21565135DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tsuo-Hung Lan, MD., PhD.
Taichung Veterans General Hospital
- STUDY DIRECTOR
Tsuo-Hung Lan, MD.,PhD
Taichung Veterans General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 11, 2010
Study Start
January 1, 2010
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
January 14, 2010
Record last verified: 2010-01