Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01045720
Status:
UNKNOWN
Last Update Posted:
2010-01-14
First Post:
2010-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D012798', 'term': 'Sialorrhea'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-13', 'studyFirstSubmitDate': '2010-01-05', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'clozapine', 'hypersalivation', 'Suo Quan Wan', 'Wu Lin San'], 'conditions': ['Schizophrenia', 'Clozapine', 'Hypersalivation', 'Traditional Chinese Medicine']}, 'referencesModule': {'references': [{'pmid': '21565135', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1.20 year and older. All genders. 2.Psychiatry doctor diagnosed schizophrenia or schizoaffective disorder will be recruited for participation in this study.\n\n3.Using clozapine as an antipsychotic drug and has a side-effect of hypersalivation.\n\n4.Testee agree and sign informed consent forms to do this experiment.\n\nExclusion Criteria:\n\n1. Use clozapine as an antipsychotic drug not over 8 weeks.\n2. Testee have other diseases could influence saliva secretion, such as Parkinson's disease.\n3. Pregnant, prepare to pregnant within half a year or in the lactation period.\n4. Add or alter following medicines within 2 weeks:\n\n 4.1 Central acting 2-adrenergic receptor agonist 4.2 anticholinergic/antimuscarinic drugs 4.3 b-adrenoreceptor blockers, diphenhydramine, botulinum toxin injection\n5. Testee's lever function test (AST/ALT) is higher than 3 (4 weeks medication).\n6. Testee's kidney function test (Cr) is higher than 2.5mg/dl (4 weeks medication).\n7. Testee have participate other medicine trial within one month."}, 'identificationModule': {'nctId': 'NCT01045720', 'briefTitle': 'The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.', 'orgStudyIdInfo': {'id': 'C08200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ChinesMed', 'interventionNames': ['Drug: Suo Quan Wan, Wu Lin San']}], 'interventions': [{'name': 'Suo Quan Wan, Wu Lin San', 'type': 'DRUG', 'description': 'Suo Quan Wan Wu Lin San Placebo 2/daily', 'armGroupLabels': ['ChinesMed']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (starch)', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tsuo-Hung Lan, MD., PhD.', 'role': 'CONTACT', 'email': 'tosafish@hotmail.com', 'phone': '886-4-23592525', 'phoneExt': '3460'}, {'name': 'Chia-Chun Hung, MD.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Tsuo-Hung Lan, MD., PhD.', 'role': 'CONTACT', 'email': 'tosafish@hotmail.com', 'phone': '04-23592525', 'phoneExt': '3460'}, {'name': 'Chia-Chun Hung, MD.', 'role': 'CONTACT', 'email': 'cocohung0418@gmail.com', 'phone': '04-23592525', 'phoneExt': '3404'}], 'overallOfficials': [{'name': 'Tsuo-Hung Lan, MD., PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taichung Veterans General Hospital'}, {'name': 'Tsuo-Hung Lan, MD.,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'IRB TCVGH', 'oldOrganization': 'Taichung Veterans General Hospital'}}}}