SchizophreniaPhase 2NCT01045720
The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia
A Phase 2 study testing Suo Quan Wan, Wu Lin San in people with Schizophrenia and Clozapine, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Clozapine, Hypersalivation
- What is being tested?
- Suo Quan Wan, Wu Lin San
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Tsuo-Hung Lan, MD., PhD., 886-4-23592525 ext. 3460, tosafish@hotmail.com
Chia-Chun Hung, MD.
About this study
Official title: The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.
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.
Read the 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.
- Being tested
- Suo Quan Wan, Wu Lin San, Placebo
- Keywords
- Schizophrenia, clozapine, hypersalivation, Suo Quan Wan, Wu Lin San
- Medical subject headings
- Schizophrenia, Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suo Quan Wan, Wu Lin SanDrug
Suo Quan Wan Wu Lin San Placebo 2/daily
PlaceboDrug
Placebo (starch)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
| ChinesMed | Experimental | Not described Receives: Drug: Suo Quan Wan, Wu Lin San |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tsuo-Hung Lan, MD., PhD., Study director, Taichung Veterans General HospitalTsuo-Hung Lan, MD.,PhD, Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045720
- Sponsor's protocol ID
- C08200
- Status last verified
- Jan 2010
- First submitted
- 5 Jan 2010
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21565135
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.
- ClinicalTrials.gov ID
- NCT01045720
- Acronym / sponsor ID
- C08200
- Keywords
- Schizophrenia, clozapine, hypersalivation, Suo Quan Wan, Wu Lin San
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: Placebo |
| ChinesMed | Experimental | Drug: Suo Quan Wan, Wu Lin San |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suo Quan Wan, Wu Lin SanSuo Quan Wan Wu Lin San Placebo 2/daily | Drug | ChinesMed |
| PlaceboPlacebo (starch) | Drug | Placebo Comparator |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Derived from this study: PubMed 21565135Hung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsuo-Hung Lan, MD., PhD. study director
Taichung Veterans General Hospital
Tsuo-Hung Lan, MD.,PhD study director
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suo Quan Wan, Wu Lin San in people with Schizophrenia and Clozapine, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsuo-Hung Lan, MD., PhD. (04-23592525 ext. 3460, tosafish@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01045720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.