A randomized controlled unblinded clinical study on the treatment of gastroesophageal reflux disease (GERD) with Tegoprazan versus Qishi Shengjiangguiyuan granule
- Conditions
- gastroesophageal reflux disease
- Registration Number
- ITMCTR2200006461
- Lead Sponsor
- Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Aged between 18 and 70.
2. Meet the diagnostic criteria for gastroesophageal reflux disease in the guidelines for primary care (2019).
3. Sign a written informed consent and be willing to comply with all research procedures.
1. Patients with other organic lesions of esophagus and gastrointestinal tract confirmed by endoscopy, these include previous total subtotal gastrectomy, esophageal stricture, achalasia, stomach or peptic ulcer, acute gastritis, Zollinger-ellison syndrome, inflammatory bowel disease, etc.
2. Current use of H2 receptor antagonist, antacids, gastrointestinal stimulants or steroids, and a history of sensitivity to PPI medications.
3. Patients with severe primary diseases, history of malignancy, or psychosis, such as cardio-cerebral vascular disease, liver disease, kidney disease, etc.
4. Persons under the age of 18 and over 70 years or pregnant or lactating women (women of reproductive age who were not pregnant before enrolment and who had used effective contraception during the course of the study may be enrolled) ; Participants in other studies within 30 days of using the study drug; alcohol and/or drug abuse (addiction or dependence) or poor adherence to the physician's judgment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GerdQ;FSSG;
- Secondary Outcome Measures
Name Time Method