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A randomized controlled unblinded clinical study on the treatment of gastroesophageal reflux disease (GERD) with Tegoprazan versus Qishi Shengjiangguiyuan granule

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
GerdQ;FSSG;
Secondary Outcome Measures
NameTimeMethod
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