Gastroesophageal reflux disease (GERD) Digestive System
Conditions
Interventions
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 he
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GERD questionnaire score, measured at baseline, 2 weeks and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Outcome results
None listed