The Efficacy of Tradition Chinese Medicine in Patients With Irritable Bowel Syndrome (TCM-IBS)
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|ClinicalTrials.gov Identifier: NCT00676975|
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Traditional Chinese Medicine Drug: Traditional Chinese Medicine Placebo||Phase 2|
Irritable bowel syndrome (IBS), characterized by abdominal pain/discomfort and disturbed bowel frequency, is a common functional bowel disorder that accounts for a substantial proportion of patients seen in primary care and secondary referral centers. The impact on patients' quality of life and the economic burden on the community are considerable. However, the outcome of conventional Western medicine in treating IBS has been disappointing. Several potential new therapeutic agents have been withdrawn because of serious adverse events. Traditional Chinese medicine (TCM) has been used in the treatment of IBS for centuries in Asian countries but scientific evaluation of its therapeutic function is scarce. A methodologically strong trial of a 20-herb formula has shown significant benefit for IBS patients. However, the herbal formulation was inadequately characterized and defined for repeated clinical studies.
Subsequent to complete chemical characterization, a randomized, placebo-controlled, double-blind, phase II dose-escalation clinical trial will be conducted to find an optimally safe and efficacious dosage of this standardized 20-herb preparation in 104 patients aged 18 to 75 with all types of IBS. At each of two dosage levels, 52 participants will be randomized to treatment for 8 weeks with the herbal formula or placebo in a 1:1 allocation ratio, and will be assessed at baseline, weeks 0, 2, 4, 8, and 12 for the clinically important and reliable outcome of patient reported global symptom improvement. At the conclusion of the 1st dosage level, safety will be assessed prior to using the higher dosage in a new cohort of participants. We also will assess individual IBS symptoms, nature, severity, duration, and frequency of adverse events, quality of life, concurrent IBS medications and health care utilization, and will perform blood tests for safety purposes. Adherence to study medication will be verified by dose counts. Results of this dose-ranging study will help to identify the optimal dosage of the herbal formula to be used in future randomized placebo-controlled trials and in head-to-head comparisons with conventional pharmaceuticals.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome(TCM- IBS)|
|Actual Study Start Date :||May 26, 2008|
|Primary Completion Date :||December 30, 2010|
|Study Completion Date :||August 30, 2011|
Active Comparator: Traditional Chinese Medicine
Traditional Chinese Medicine 17g herbal extract
Drug: Traditional Chinese Medicine
A herbal extract 17g once daily for 8 weeks for lower dosage, and 34g for higher dosage.
The 20-herb formulation are Agastache rugosa,Fraxinus rhynchophylla, Angelica dahurica,Glycyrrhiza uralensis, Artemisia capillaris, Magnolia officinalis, Atractylodes macrocephala,Paeonia lactiflora, Aucklandia lappa, Plantago asiatica,Bupleurum chinense, Phellodendron amurense, Citrus reticulate, Poria cocos, Codonopsis pilosula, Saposhnikovia diraricata, Coix lacryma-jobi, Schisandra chinensis, Coptis chinensis, Zingiber officinale
Placebo Comparator: Traditional Chinese Medicine Placebo
Drug: Traditional Chinese Medicine Placebo
Placebo once daily for 8 weeks
- Patient reported global symptom improvement, based on this question: "Have you had adequate relief of your symptoms over the last two weeks"? (yes/no) [ Time Frame: 12 weeks ]
- Bowel Symptom Scale (BSS): to assess changes in individual IBS and global IBS symptoms. QoL assessment:one disease-specific (IBS-QoL) and one generic (SF-36), will be used. [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676975
|Li Ka Shing Specialist Clinic, Prince of Wales Hospital|
|Hong Kong (SAR), China, 852|
|Principal Investigator:||Francis KL Chan, MD||Chinese University of Hong Kong|