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

NCT02179580 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-07-02

No results posted yet for this study

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

Interventions

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 .

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Hsuehchou Lai, MD · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02179580 on ClinicalTrials.gov