Plain English Summary
Background and study aims.
Diarrhoea-predominant irritable bowel syndrome (IBS-D) affects around 3% of the population and is characterised by abdominal pain and frequent loose bowel movements. There are few treatments for these symptoms that work and this study aims to see whether Jianpi Shugan recipe might help those with IBS-D. Previous studies have suggested a benefit but this needs to be confirmed.
Who can participate?
Patients diagnosed by their doctors as having diarrhoea-predominant irritable bowel syndrome .
What does the study involve?
Patients will be randomly allocated either to take Jianpi Shugan recipe herbal granules with a placebo (dummy) tablet, or to take Pinaverium with placebo granules for 4 weeks. At the beginning of the study, an examination of the lower bowel will be made and a small specimen taken from the lining (biopsy). This procedure is routinely performed to identify the different causes of diarrhoea.
What are the possible benefits and risks of participating?
We are hoping that towards the end of the 4-week period diarrhoea and abdominal pain will improve. The drugs has been used for many years and the side effects are well recognised. Only a very few will not tolerate the drug because of abdominal discomfort, constipation, diarrhoea, nausea, rash etc.
Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing Chaoyang Hospital affiliated to Capital Medical University
The First Affiliated Hospital of Henan University of TCM
First Teaching Hospital of Tianjin University of TCM
Second Affiliated Hospital of Tianjin University of TCM
When is the study starting and how long is it expected to run for?
From April 2015 and to March 2016.
Who is funding the study?
Beijing municipal administration of hospitals (China).
Who is the main contact?
Dr Shengsheng Zhang
zhss2000@163.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Luqing Zhao
ORCID ID
http://orcid.org/0000-0003-1986-3511
Contact details
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
No. 23 Meishuguan Back Street
Dongcheng District
Beijing
100010
China
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of Jianpi Shugan recipe in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): a multicentre parallel-group randomised controlled trial
Acronym
Study hypothesis
The purpose of the trial is to define the clinical benefit of Jianpi Shugan recipe in diarrhoea-predominant irritable bowel syndrome (IBS-D) . The primary endpoint is to assess the effect of Jianpi Shugan recipe on IBS Symptom Severity Score (IBS-SSS).
Ethics approval
Ethics committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 15/02/2015, NO.2015BL-008-02
Study design
Multicentre parallel-group double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Diarrhoea-predominant irritable bowel syndrome (IBS-D)
Intervention
Patients will be randomized to receive either Jianpi Shugan recipe herbal granules + matching Pinaverium placebo or Pinaverium + matching Jianpi Shugan recipe herbal placebo granules for 4 weeks. Herbal granules were dissolved in 300 ml of boiled water, 150 ml twice daily, Pinaverium 50 mg three times a day.
Intervention type
Drug
Phase
Not Applicable
Drug names
Pinaverium
Primary outcome measure
IBS Symptom Severity Score (IBS-SSS) measured at baseline, 2 weeks and 4 weeks
Secondary outcome measures
1. Traditional Chinese Medicine syndromes of IBS score measured at baseline, 2 weeks and 4 weeks
2. Defection state questionnaire (DSQ) for IBS noted by patients daily
3. Irritable bowel syndrome-quality of life questionnaire (IBS-QOL) at baseline and 4 weeks
4. Serum concentration of serotonin at baseline and 4 weeks
Overall trial start date
01/04/2015
Overall trial end date
31/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with IBS-D meeting the Rome III criteria
2. Patients meeting the Traditional Chinese Medicine syndrome of liver-depression and spleen-deficiency criteria
3. Patients able to give informed consent
4. Female patients of childbearing potential are willing to use at least one highly effective contraceptive method
5. Aged 18-65 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
260
Participant exclusion criteria
1. Women who are pregnant or breastfeeding
2. Prior abdominal surgery which may cause bowel symptoms similar to IBS
3. Patients with the following diarrhea conditions: infection, systemic diseases, poisoning or cancer
4. Patients with serious concomitant diseases e.g. cardiovascular, renal, hepatic, respiratory, neurological, endocrine, hematopoietic etc
5. Patients with a history of alcoholic or drug abuse
6. Patients who have allergic constitution or known to be allergic to the drug used in this trial
7. Patients who are involved in other trials
8. Patients with poor compliance or other reasons that the researcher considered not to be appropriate to participate in this trial
Recruitment start date
01/06/2015
Recruitment end date
01/03/2016
Locations
Countries of recruitment
China
Trial participating centre
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China
Trial participating centre
Beijing Chaoyang Hospital affiliated to Capital Medical University
Beijing
China
Trial participating centre
The First Affiliated Hospital of Henan University of TCM
Zhengzhou
China
Trial participating centre
First Teaching Hospital of Tianjin University of TCM
Tianjin
China
Trial participating centre
Second Affiliated Hospital of Tianjin University of TCM
Tianjin
China
Funders
Funder type
Hospital/treatment centre
Funder name
Beijing municipal administration of hospitals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list