Condition category
Digestive System
Date applied
21/11/2018
Date assigned
30/11/2018
Last edited
30/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Prof Shengsheng Zhang

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2018-09-26

Study information

Scientific title

Effects of Renzhuchangle grannule on diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled phase IIa study

Acronym

Study hypothesis

The Renzhuchangle granule is more effective in the treatment of diarrhoea-predominant irritable bowel syndrome than the placebo

Ethics approval

Ethics committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 05/11/2018, NO.2017BL-058-04

Study design

Interventional multi-centre double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

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

Phase

Phase II

Drug names

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 trial start date

01/03/2018

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

108

Participant 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

Recruitment start date

01/12/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing
10010
China

Trial participating centre

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
300193
China

Trial participating centre

Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Nanning
530011
China

Trial participating centre

West China Hospital,Sichuan University
Chengdu
610044
China

Trial participating centre

Hubei Province Hospital of Traditional Chinese Medicine
Wuhan
430061
China

Sponsor information

Organisation

Purapharm (Nanning) Pharmaceuticals Co. Limited

Sponsor details

NO.46 keyuan street,Xixiangtang District
Nanning
530000
China

Sponsor type

Industry

Website

Funders

Funder type

Not defined

Funder name

Purapharm (Nanning) Pharmaceuticals Co. Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to data security.

Intention to publish date

31/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes