Treatment of Shugan Hewei recipe in the treatment of gastroesophageal reflux disease (GERD)
| ISRCTN | ISRCTN17685397 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17685397 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/03/2015
- Registration date
- 08/04/2015
- Last edited
- 17/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
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 Shugan Hewei recipe in the treatment of gastroesophageal reflux disease (GERD): a multicentre parallel-group randomised controlled trial |
| Study objectives | 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(s) | Ethics committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 03/07/2015, NO.2015BL-007-02 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Omeprazole, Shugan Hewei recipe herbal granules |
| Primary outcome measure | 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 study start date | 01/04/2015 |
| Completion date | 30/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 288 |
| Total final enrolment | 288 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 31/08/2017 |
Locations
Countries of recruitment
- China
Study participating centres
100010
China
100032
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/07/2021 | 17/05/2023 | Yes | No |
Editorial Notes
17/05/2023: Publication reference and total final enrolment added.
