The Efficacy of Tradition Chinese Medicine in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To test the efficacy of Traditional Chinese Medicine in relieving symptoms and change of
      quality of life of patients with Irritable Bowel Syndrome.
    

Detailed description: 
      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      potential new therapeutic agents have been withdrawn because of serious adverse events.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.
    

Intervention name(s): Traditional Chinese Medicine; Traditional Chinese Medicine Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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 once daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel disease; Traditional Chinese Medicine