ITMCTR2000003951
Not yet recruiting
Phase 1
Clinical study on precise diagnosis and treatment of refractory gastroesophageal reflux disease by Traditional Chinese medicine based on intestinal microecological macroomics technology
Shanghai Traditional Chinese Medicine Hospital0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shanghai Traditional Chinese Medicine Hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The research content 1
- •1\.Inclusion criteria for subjects with refractory gastroesophageal reflux disease
- •A. Meet the diagnostic criteria of gastroesophageal reflux disease;
- •B. Eight weeks of standard PPI treatment for failure with gastroesophageal reflux disease prior to this study;
- •C. Between the ages of 18 and 65, regardless of gender;
- •D. The patient is informed and signs the informed consent.
- •2\.Inclusion criteria for healthy subjects:
- •A. Healthy volunteers who had physical examination in our hospital;
- •B. Between the ages of 18 and 65, regardless of gender;
- •C. The patient is informed and signs the informed consent.
Exclusion Criteria
- •The research content 1
- •A. Patients with one of the following diseases: peptic ulcer, history of gastroesophageal and duodenal surgery, Zo\-AIDS syndrome, primary esophageal motional diseases (such as achalasia of cardia, scleroderma, primary esophageal spasm), malignant lesions of upper digestive tract, coronary heart disease, diabetes, drug esophagitis.
- •B. Pregnant or lactating women,
- •C. Allergic constitution and psychosis.
- •D. The patient was a researcher directly involved in this clinical study.
- •E. Simultaneous use of drugs that may affect the efficacy and safety of drugs.
- •F. It was considered that there were any circumstances unsuitable for inclusion in the study.
- •The research content 2
- •A. Patients with one of the following diseases: peptic ulcer, history of gastroesophageal and duodenal surgery, Zo\-AIDS syndrome, primary esophageal motional diseases (such as achalasia of cardia, scleroderma, primary esophageal spasm), malignant lesions of upper digestive tract, coronary heart disease, diabetes, drug esophagitis.
- •B. Pregnant or lactating women,
Outcomes
Primary Outcomes
Not specified
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