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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
ITMCTR
Registry ID
ITMCTR2100005388
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-12-15
Completion date
Unknown
Last updated
2023-02-20

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) 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

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.

Design outcomes

Primary

MeasureTime frame
DeMeester score;

Secondary

MeasureTime frame
TCM clinical symptom score;Hamilton Depression and Anxiety Scale score;Gerd-q scale score;

Countries

China

Contacts

Public ContactWang Zhiqiang
tjmu_wzq@sina.com18600574258

Outcome results

None listed

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