MedPath

Clinical study of Qinggan Hewei Prescription in treating refractory gastroesophageal reflux disease of liver and stomach gloomy heat type

Phase 1
Recruiting
Conditions
Refractory gastroesophageal reflux disease
Registration Number
ITMCTR2100005388
Lead Sponsor
Beijing Pinggu District Hospital of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Aged 18-65;
(2) The diagnosis was consistent with non-erosive RGERD;
(3) TCM syndrome differentiation is consistent with the syndrome of liver and stomach stagnation heat;
(4) Gastroscopy was basically normal, allowing superficial gastritis or atrophic gastritis;
(5) Consent to 24h esophageal ph-impedance test, and sign informed consent.

Exclusion Criteria

(1) A history of gastric, esophageal and duodenal operations.
(2) There are drug esophagitis, fungal esophagitis, corrosive esophagitis, achalasia from the cardia, hiatal hernia, eosinophilic esophagitis, immune-related esophageal diseases.
(3) Suspected or confirmed malignant diseases or any early warning symptoms, and organic diseases of digestive tract (digestive ulcer, digestive tract tumor, inflammatory bowel disease, etc.) were found in previous examinations.
(4) have serious primary heart, liver, lung, kidney, pancreas, liver or serious diseases affecting their survival.
(5) Legally prescribed patients with disabilities (blindness, deafness, muteness, intellectual handicap, mental handicap and physical disability, etc.).
(6) Suspected or confirmed history of alcohol and drug abuse.
(7) Allergic constitution, such as the history of allergic to two or more drugs or food; Or known to be allergic to the drug ingredient.
(8) Patients with mental system diseases, whose symptoms are not clearly expressed or who cannot communicate with doctors normally.
(9) pregnant women or breast-feeding women, or women planning to become pregnant within 3 months.
(10) Patients with RGERD due to poor compliance.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
DeMeester score;
Secondary Outcome Measures
NameTimeMethod
TCM clinical symptom score;Hamilton Depression and Anxiety Scale score;Gerd-q scale score;
© Copyright 2025. All Rights Reserved by MedPath