ClinicalTrials.Veeva

Menu

The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia

T

Taichung Veterans General Hospital

Status and phase

Unknown
Phase 2

Conditions

Hypersalivation
Traditional Chinese Medicine
Schizophrenia
Clozapine

Treatments

Drug: Suo Quan Wan, Wu Lin San
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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

  1. Use clozapine as an antipsychotic drug not over 8 weeks.

  2. Testee have other diseases could influence saliva secretion, such as Parkinson's disease.

  3. Pregnant, prepare to pregnant within half a year or in the lactation period.

  4. 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

  5. Testee's lever function test (AST/ALT) is higher than 3 (4 weeks medication).

  6. Testee's kidney function test (Cr) is higher than 2.5mg/dl (4 weeks medication).

  7. Testee have participate other medicine trial within one month.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 2 patient groups, including a placebo group

Placebo Comparator
Placebo Comparator group
Treatment:
Drug: Placebo
ChinesMed
Experimental group
Treatment:
Drug: Suo Quan Wan, Wu Lin San

Trial contacts and locations

1

Loading...

Central trial contact

Tsuo-Hung Lan, MD., PhD.; Chia-Chun Hung, MD.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems