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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054125
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-12-15
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory gastroesophageal reflux disease

Interventions

Sponsors

Beijing Pinggu District Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18-65 years old; 2. The diagnosis is consistent with non-erosive RGERD; 3. TCM syndrome differentiation is in line with liver and stomach stagnation and heat syndrome; 4. The gastroscopy is basically normal, and superficial gastritis or atrophic gastritis is allowed; 5. Agree to perform 24h esophageal pH-impedance test and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. History of gastric, esophageal and duodenal surgery; 2. Drug-induced esophagitis, fungal esophagitis, erosive esophagitis, achalasia, hiatal hernia, eosinophilic esophagitis, immune-related esophageal diseases; 3. Suspected or confirmed to have malignant disease or have any early warning symptoms, and previous examinations found organic lesions of the digestive tract (digestive tract ulcer, digestive tract tumor, inflammatory bowel disease, etc.); 4. Have serious primary heart, liver, lung, kidney, pancreas, liver or serious diseases that affect their survival; 5. Disabled patients specified by law (blind, deaf, dumb, intellectually disabled, mentally disabled and physically disabled, etc.); 6. Suspect or have a history of alcohol or drug abuse; 7. Allergic constitution, such as those with a history of allergies to two or more drugs or food; or known allergies to the ingredients of this medicine; 8. Patients with mental system diseases, who cannot express the symptoms of the disease or cannot communicate with doctors normally; 9. Pregnant or lactating women, or women planning to become pregnant within 3 months; 10. Patients with RGERD due to poor compliance.

Design outcomes

Primary

MeasureTime frame
Esophageal pH Monitoring DeMeester Score;

Secondary

MeasureTime frame
Gastroesophageal Reflux Disease Scale (GERDQ);TCM clinical symptom score;Hamilton Depression and Anxiety Scale score;

Countries

China

Contacts

Public ContactWang Zhiqiang

Beijing Pinggu District Hospital of Traditional Chinese Medicine

tjmu_wzq@sina.com+86 18600574258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026