Treatment of Shugan Hewei recipe in the treatment of gastroesophageal reflux disease (GERD)
- Conditions
- Gastroesophageal reflux disease (GERD)Digestive System
- Registration Number
- ISRCTN17685397
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34366631/ (added 17/05/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 288
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GERD questionnaire score, measured at baseline, 2 weeks and 4 weeks
- Secondary Outcome Measures
Name Time Method 1. Traditional Chinese Medicine syndromes of IBS score, measured at baseline, 2 weeks and 4 weeks<br>2. High resolution manometry (HRM), measured at baseline and 4 weeks