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

NCT02179580 | Unknown Phase 2 DMC

• 1 other identifier: CMUH103-REC2-016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Traditional Chinese Medicine; Clinical trial; Good Clinical Practice

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal System Rating Scale-IBS Questionnaire

  Change from baseline Gastrointestinal System Rating Scale-IBS score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days)

Secondary Outcomes (1)

• IBS-QOL Questionnaire

  Change from baseline IBS-QOL score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days)

Other Outcomes (1)

• WHO Quality Questionnaire

  Change from baseline WHO Quality of Life-BREF score at week 4 (28 ± 5 days) and week 12 (84 ± 7 days)

Study Arms (2)

Xiang-Sha-Liu-Jun-Zi-Tang

EXPERIMENTAL

Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days

Drug: Xiang-Sha-Liu-Jun-Zi-Tang; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo at a rate of 3.0 g three times per day for 28 days

Drug: Xiang-Sha-Liu-Jun-Zi-Tang; Drug: Placebo

Interventions

Xiang-Sha-Liu-Jun-Zi-Tang DRUG

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

Placebo; Xiang-Sha-Liu-Jun-Zi-Tang

Placebo DRUG

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 .

Placebo; Xiang-Sha-Liu-Jun-Zi-Tang

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating.
• Elevated serum ALT / AST level (3 x upper limit of normal (ULN)),or greater than normal serum Creatinine.
• The clients with psychological cannot cooperate with each other. ( ex. depression, schizophrenia )
• Abdominal surgery.
• Major medical diseases. ( ex. heart failure, myocardial infarction, chronic obstructive pulmonary disease, kidney failure, cancer, stroke )
• The patient refused to sign informed consent form.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hsuehchou Lai, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsueh-Chou Lai

CONTACT

+886-4-22052121; d3145@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: July 2, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 2, 2014

Record last verified: 2014-06

Locations

TW (1)