Standardized study for Hezhong Jianpi Decoction in the drug withdrawal of cases of proton pump inhibitor-dependent gastroesophageal reflux disease
- Conditions
- gastroesophageal reflux disease
- Registration Number
- ITMCTR1900002342
- Lead Sponsor
- Shanghai Municipal Hospital of Shanghai TCM University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patient with gastroesophageal reflux disease more than 3 months;
2. Dependence on PPI, that is, those who have taken PPI for more than 2 months, but could not withdraw, and occurred reflux or other symptoms after more than 3-day withdrawal;
3. Male or female aged 18 to 70 years;
4. The voluntary participation in the trial, informed consent, and signed the agreement.
1. The pregnant or lactating women;
2. The combination of the following diseases: suspected or proven malignant tumor, peptic ulcer, esophageal and gastric or duodenal surgery, Zollinger Ellison syndrome, primary esophageal motility disorders (such as achalasia, scleroderma, primary esophageal spasm), upper gastrointestinal malignant disease, drug-induced esophageal inflammation, pyloric obstruction;
3. The serious cardiovascular disease, liver and kidney dysfunction;
4. There is psychotic or language disorder;
5. It is not partners (that cannot match the diagnosis or not according to the provisions of medication and influence curative effect).
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical symptom score;RDQ;
- Secondary Outcome Measures
Name Time Method GERD-HRQL;SF-36;