The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious and safe dosage of the formulation in treating IBS.
The Specific aims of the project are: 1. To determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine. 2. To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized clinical trial, in conjunction with indices of safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
104
Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks
Placebo herb formulation
Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong
Shatin, Hong Kong
Global IBS symptom improvement
The primary endpoint for this study is the efficacy at the 8 week followup visit of the herbal formulations, which is defined by the patient's global assessment of the IBS symptoms.
Time frame: 8 weeks
The Bowel Symptom Scale (BSS):
The Bowel Symptom Scale will be used to assess changes in individual IBS and global IBS symptoms during the course of illness.
Time frame: 8 weeks
SF-36
Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment.
Time frame: 8 weeks
IBS-QoL
Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment.
Time frame: 8 weeks
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