Effects of the Renzhuchangle granule on diarrhoea-predominant irritable bowel syndrome
| ISRCTN | ISRCTN42639030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42639030 |
| Secondary identifying numbers | 2018-09-26 |
- Submission date
- 21/11/2018
- Registration date
- 30/11/2018
- Last edited
- 30/01/2023
- 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 symptoms include abdominal pain and frequent loose bowel movements. This study aims to determine whether the Renzhuchangle granule might help those IBS-D, as previous studies have shown it may be beneficial
Who can participate?
Adults aged 18-65 who have been diagnosed by their doctors as having diarrhoea-predominant irritable bowel syndrome
What does the study involve?
Participants will be randomly allocated to one of three treatments:
1. Renzhuchangle granule treatment - 8 g, 3 times per day for 8 weeks
2. Placebo treatment - 8 g, 3 times per day for 8 weeks
3. Renzhuchangle granule treatment - 4 g, 3 times per day for 8 weeks AND placebo treatment - 4 g, 3 times per day for 8 weeks
There will be an 8 week follow up period following 8 weeks of medication.
What are the possible benefits and risks of participating?
The possible benefit of participating is that the Renzhuchangle granule may improve symptoms of diarrhoea and abdominal pain, although this cannot be guaranteed. The possible risks of participating is that the treatment may cause side effects including abdominal discomfort, constipation, diarrhoea, nausea and rash, although this is unlikely.
Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University and 4 other hospitals in China
When is the study starting and how long is it expected to run for?
December 2018 to December 2020
Who is funding the study?
Purapharm (Nanning) Pharmaceuticals Co. Limited (China)
Who is the main contact?
Dr Shengsheng Zhang
zhss2000@163.com
Contact information
Public
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, 23 Meishuguanhou Street, Dongcheng District
Beijing
100010
China
Study information
| Study design | Interventional multi-centre double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effects of Renzhuchangle grannule on diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled phase IIa study |
| Study objectives | The Renzhuchangle granule is more effective in the treatment of diarrhoea-predominant irritable bowel syndrome than the placebo |
| Ethics approval(s) | Ethics committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 05/11/2018, NO.2017BL-058-04 |
| Health condition(s) or problem(s) studied | Diarrhoea-predominant irritable bowel syndrome (IBS-D) |
| Intervention | Participants are randomly allocated to one of three groups using SAS9.10 software: 1. Renzhuchangle granule 8 g, taken orally three times per day for 8 weeks 2. Renzhuchangle granule 4 g taken orally three times per day for 8 weeks, and matching Renzhuchangle granule placebo 4 g taken orally three times per day for 8 weeks 3. Matching Renzhuchangle granule placebo 8 g, taken orally three times per day for 8 weeks Following completion of this 8 week period, there is another 8 week follow-up period. Patients and investigators are all blinded to treatment allocation. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Renzhuchangle granule |
| Primary outcome measure | The following will be assessed by reviewing patient notes at the baseline and weekly from weeks 1-8: 1. Abdominal pain score 2. Stool consistency |
| Secondary outcome measures | 1. Abdominal bloating, assessed by reviewing patient notes at the baseline and after 2, 4 and 8 weeks 2. IBS symptom servirty, assessed using the Irritable Bowel Syndrome Symptom Severity Scoring System (IBS-SSS) at the baseline and after 8 weeks 3. Traditional Chinese Medicine syndromes of IBS score, assessed at the baseline and after 8 weeks 4. Quality of life, assessed using the Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL) at the baseline and after 8 weeks |
| Overall study start date | 01/03/2018 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 108 |
| Key inclusion criteria | 1. Diarrhoea-predominant irritable bowel syndrome (IBS-D) meeting the Rome IV criteria 2. Meeting the Traditional Chinese Medicine syndrome of liver-depression and spleen-deficiency criteria 3. Aged 18 to 65 4. Voluntary acceptance of the medication 5. Signed informed consent 6. Average daily worst abdominal pain score ≥3 during the last week of screening phase 7. More than two days of ≥1 loose stools (Bristol Stool Scale 6 or 7) during the last week of screening phase |
| Key exclusion criteria | 1. Prior abdominal surgery which may cause bowel symptoms similar to IBS 2. Diarrhoea as a result of any of the following: 2.1. Infection 2.2. Systemic diseases 2.3. Poisoning 2.4. Cancer 3. Serious concomitant diseases, including cardiovascular, renal, hepatic, respiratory, neurological, endocrine or haematopoietic diseases 4. History of alcohol or drug abuse 5. Allergic constitution or known to be allergic to the drug used in this trial 6. Involved in other trials 7. Pregnant or breastfeeding, or plan to become pregnant soon 8. Poor compliance or any other reason the research believers they may not be appropriate to participate in this trial |
| Date of first enrolment | 01/12/2018 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- China
Study participating centres
10010
China
300193
China
530011
China
610044
China
430061
China
Sponsor information
Industry
NO.46 keyuan street，Xixiangtang District
Nanning
530000
China
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to data security. |
Editorial Notes
30/01/2023: Internal review.
19/12/2018: Internal review.
