Condition category
Digestive System
Date applied
24/03/2015
Date assigned
08/04/2015
Last edited
08/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Gastro-oesophageal reflux disease (GORD) is a common condition where acid from the stomach leaks out of the stomach and up into the oesophagus (gullet). Some patients’ symptoms persist despite treatment with drugs. This study aims to see whether Shugan Hewei recipe might help those with GERD. Previous studies have suggested a benefit but this needs confirmation.

Who can participate?
Patients diagnosed by their doctors as having gastroesophageal reflux disease (GERD).

What does the study involve?
Participants will be randomly allocated to take either Shugan Hewei recipe herbal granules and a placebo (dummy) tablet for 4 weeks, or an Omeprazole tablet and placebo granules for 4 weeks.

What are the possible benefits and risks of participating?
We are hoping that towards the end of the 4-week period reflux and heartburn will improve. The drugs have been used for many years and the side effects are well recognised. Only a very few will not tolerate the drug because of stomach discomfort, dryness of the mouth, constipation, diarrhoea, nausea, rash or dizziness.

Where is the study run from?
1. Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
2. Peking Union Medical College Hospital
3. Beijing Shijitan Hospital
4. Shengjing Hospital of China Medical University

When is the study starting and how long is it expected to run for?
From April 2015 to September 2017.

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 Shugan Hewei recipe in the treatment of gastroesophageal reflux disease (GERD): a multicentre parallel-group randomised controlled trial

Acronym

Study hypothesis

The purpose of the trial is to define the clinical benefit of Shugan Hewei recipe in gastroesophageal reflux disease (GERD). The primary endpoint is to assess the effect of Shugan Hewei recipe on GERD questionnaire Score.

Ethics approval

Ethics committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 03/07/2015, NO.2015BL-007-02

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

Gastroesophageal reflux disease (GERD)

Intervention

Participants will be randomized to receive either:
1. Shugan Hewei recipe herbal granules and matching Omeprazole placebo tablet for 4 weeks or
2. Omeprazole tablet and matching Shugan Hewei recipe herbal placebo granules for 4 weeks.

Herbal granules were dissolved in 300 ml of boiled water, 150 ml twice daily.
Omeprazole tablet 20 mg once a day, on an empty stomach.

Intervention type

Drug

Phase

Not Applicable

Drug names

Omeprazole, Shugan Hewei recipe herbal granules

Primary outcome measures

GERD questionnaire score, 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. High resolution manometry (HRM), measured at baseline and 4 weeks

Overall trial start date

01/04/2015

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with GERD, GERD questionnaire score >8
2. Patients able to give informed consent
3. Female patients of childbearing potential who are willing to use at least one highly effective contraceptive method
4. Aged 18-65 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

288

Participant exclusion criteria

1. Women who are pregnant or breastfeeding
2. Patients with Zollinger-Ellison syndrome or primary esophageal dynamic disease
3. Patients with serious concomitant diseases e.g. cardiovascular, renal, hepatic, respiratory, neurological, endocrine, hematopoietic etc
4. Patients with early warning symptoms of malignant tumors
5. Patients who were taking proton-pump inhibitor or H2 receptor antagonist during the prior 2 weeks
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

01/04/2015

Recruitment end date

31/08/2017

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

Peking Union Medical College Hospital
Beijing
100032
China

Trial participating centre

Beijing Shijitan Hospital
Beijing
China

Trial participating centre

Shengjing Hospital of China Medical University
Shenyang
China

Sponsor information

Organisation

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Sponsor details

No. 23 Meishuguan Back Street
Dongcheng District
Beijing
100010
China

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes