Treatment of Jianpi Shugan recipe in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D)
| ISRCTN | ISRCTN66631530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66631530 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/03/2015
- Registration date
- 08/04/2015
- Last edited
- 08/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
No. 23 Meishuguan Back Street
Dongcheng District
Beijing
100010
China
 ORCID ID |
0000-0003-1986-3511 |
|---|
Study information
| Study design | Multicentre parallel-group double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Ethics committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 15/02/2015, NO.2015BL-008-02 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2015 |
| Completion date | 31/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 260 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 01/03/2016 |
Locations
Countries of recruitment
- China
Study participating centres
100010
China
China
China
China
China
Sponsor information
Hospital/treatment centre
No. 23 Meishuguan Back Street
Dongcheng District
Beijing
100010
China
"ROR" |
https://ror.org/057vq6e26 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
