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A Study of Xiang-Sha-Liu-Jun-Zi-Tang in Patients With Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT02179580
Recruitment Status : Unknown
Verified June 2014 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : July 2, 2014
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE May 27, 2014
First Posted Date  ICMJE July 2, 2014
Last Update Posted Date July 2, 2014
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
Gastrointestinal System Rating Scale-IBS Questionnaire [ Time Frame: Change from baseline Gastrointestinal System Rating Scale-IBS score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
IBS-QOL Questionnaire [ Time Frame: Change from baseline IBS-QOL score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 30, 2014)
WHO Quality Questionnaire [ Time Frame: Change from baseline WHO Quality of Life-BREF score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Xiang-Sha-Liu-Jun-Zi-Tang in Patients With Irritable Bowel Syndrome
Official Title  ICMJE A Randomized Double Blind Placebo Control Study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT)in Patients With Irritable Bowel Syndrome
Brief Summary Ministry of Health and Welfare Department of Chinese Medicine and pharmacy specially subsidizes domestic teaching hospitals to install clinical study centers for Chinese pharmacies, in order to establish the clinical study environment for Chinese pharmacies meeting the international regulations, to assist promoting and performing clinical studies in Chinese pharmacies, and then to improve the nation's health and benefits. This will render Chinese pharmacies competitive in the international market by employing scientific tests and verifications. The new project applications are respectively as follows: A randomized double blind placebo control study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) in patients with irritable bowel syndrome The main clinical manifestations of irritable bowel syndrome (IBS) are chronic, recurrent abdominal pain or abdominal dyscomfortable associated with the changes of defecation habit, such as constipation and/or diarrhea. Clinical treatment of IBS includes behavioral, and drug treatment, such as anti-diarrheal agent, 5-HT3 receptor antagonist and 5-HT4 receptor agonist, but these treatments relieve partial symptoms only. Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) origins from Yizongjinjion, and that uses XSLJZT to treat the patients who has qi deficiency, phlegm-retained fluid, nausea and vomiting, gastrointestinal dysharmony and producing many symptoms. These symptoms of mentioned-above are similar to IBS. Therefore, the purpose of the present study was to investigate the therapeutic effect of XSLJZT on IBS, the investigators designed a randomized double blind placebo control study to assess the effect of XSLJZT on IBS.
Detailed Description

Ministry of Health and Welfare Department of Chinese Medicine and pharmacy specially subsidizes domestic teaching hospitals to install clinical study centers for Chinese pharmacies, in order to establish the clinical study environment for Chinese pharmacies meeting the international regulations, to assist promoting and performing clinical studies in Chinese pharmacies, and then to improve the nation's health and benefits. This will render Chinese pharmacies competitive in the international market by employing scientific tests and verifications. The new project applications are respectively as follows: A randomized double blind placebo control study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) in patients with irritable bowel syndrome The main clinical manifestations of irritable bowel syndrome (IBS) are chronic, recurrent abdominal pain or abdominal dyscomfortable associated with the changes of defecation habit, such as constipation and/or diarrhea. Clinical treatment of IBS includes behavioral, and drug treatment, such as anti-diarrheal agent, 5-HT3 receptor antagonist and 5-HT4 receptor agonist, but these treatments relieve partial symptoms only. Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) origins from Yizongjinjion, and that uses XSLJZT to treat the patients who has qi deficiency, phlegm-retained fluid, nausea and vomiting, gastrointestinal dysharmony and producing many symptoms. These symptoms of mentioned-above are similar to IBS. Therefore, the purpose of the present study was to investigate the therapeutic effect of XSLJZT on IBS, we designed a randomized double blind placebo control study to assess the effect of XSLJZT on IBS.

In addition to the performance of the clinical study projects for Chinese pharmacies, our center will still maintain cooperation with domestic or foreign biotechnology industries, the industries of Chinese herbal medicine and academic research institutes, such as the material research institute in Industrial Technology Research Institute, Feng Chia University, and Yuanpei University, make efforts in expanding the study in the development of novel Chinese medicinal drugs and novel medical techniques, and cooperate with famous international Contract Research Organizations (CRO). We want to build a clinical study service platform, in which the internal part is to integrate various R&D units on campuses and hospitals, such as the teams in the department of medical care, department of medical technology, all laboratories, the incubation center, the biostatistics center, the administrative department and improve the internal procedures for performing clinical studies. The external part is to make efforts to win over domestic and foreign clinical study cases to be performed in our center. The performing methods are illustrated as follows:

  1. Setting up the environment and related equipment that enable the performance of clinical studies in Chinese pharmacies and establishing the operation manuals and standard operation procedures for performing the R&D stage for drugs of Chinese pharmacies.
  2. Employing professionals required in the clinical study in Chinese pharmacies and encouraging doctors, pharmacists and nurses to attend advanced study and receive training while enhancing the incubation for the required professionals of clinical studies, such that the experience can be passed to others.
  3. Practically performing one or more proposals of developing new drugs of Chinese pharmacies or the clinical study proposal of reassessing therapeutic efficacies of drugs in the drug permission certificates issued by the Committee on Chinese Medicine and Pharmacy on record.
  4. Promoting and building an intact and strong audit system in accordance with Good Clinical Practice (GCP), elevating the clinical study level in our country, and putting the regulations of GLP into practice.
  5. Promoting the cooperation with industries, academics, and governments and international cooperation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Xiang-Sha-Liu-Jun-Zi-Tang
    Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days. We use the Chinese herb for the treat of IBS patient
  • Drug: Placebo
    Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days. Placebo drug is 1/10 dose of experiment drug .
Study Arms  ICMJE
  • Experimental: Xiang-Sha-Liu-Jun-Zi-Tang
    Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days
    Interventions:
    • Drug: Xiang-Sha-Liu-Jun-Zi-Tang
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo at a rate of 3.0 g three times per day for 28 days
    Interventions:
    • Drug: Xiang-Sha-Liu-Jun-Zi-Tang
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 30, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age : from 20 y/o to 65 y/o.
  2. Gender : male or female.

Exclusion Criteria:

  1. Pregnant or lactating.
  2. Elevated serum ALT / AST level (3 x upper limit of normal (ULN)),or greater than normal serum Creatinine.
  3. The clients with psychological cannot cooperate with each other. ( ex. depression, schizophrenia )
  4. Abdominal surgery.
  5. Major medical diseases. ( ex. heart failure, myocardial infarction, chronic obstructive pulmonary disease, kidney failure, cancer, stroke )
  6. The patient refused to sign informed consent form.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02179580
Other Study ID Numbers  ICMJE CMUH103-REC2-016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hsuehchou Lai, MD China Medical University Hospital
PRS Account China Medical University Hospital
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP