The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Clinical Study to Test the Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With IBS
1 other identifier
interventional
84
1 country
1
Brief Summary
To test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with IBS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMay 13, 2008
May 1, 2008
1.7 years
September 8, 2005
May 9, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The global assessment of IBS symptom by patients.
16 weeks
Secondary Outcomes (1)
Individual IBS symptoms and QOL assessment
16 weeks
Study Arms (3)
Traditional Chinese Medicine
EXPERIMENTALThey are Common peony root, other herbs.
Holopon
ACTIVE COMPARATORHolopon
placebo
PLACEBO COMPARATORPlacebo
Interventions
They are Common peony root, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Lactiflorae, Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, and Rhizoma Corydalis Yanhusuo.
Eligibility Criteria
You may qualify if:
- All patients (aged 18-65) attending the Gastroenterology Clinic of the Prince of Wales Hospital or Hong Kong Baptist University Chinese Medicine clinics for symptoms of IBS will be enrolled in the study.
- IBS is diagnosed by Rome II criteria \[Thompson et al. Gut 2000\]: At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features: relieved with defecation; and/or onset associated with a change in frequency of stool; and/or onset associated with a change in form (appearance) of stool
- Normal colonic evaluation (colonoscopy or barium enema) in recent 5 years
- Mean score of abdominal discomfort/pain,based on a 5-point scale,at baseline and during the 2-week run-in period
- Informed written consent for participation into study.
- Ethical approval will be obtained from the Clinical Research Ethics Committee of the University
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Li Ka Shing Specialist Clinic, Prince of Wales Hospital
Hong Kong (sar), China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph JY Sung, MD
CUHK
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
September 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
May 13, 2008
Record last verified: 2008-05