non-erosive reflux disease
Conditions
Interventions
treatment group:Yangyin Yiwei Decoction plus Omeprazole placebo
control group:Yangyin Yiwei Decoction placebo plus Omeprazole
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. meet the corresponding diagnostic criteria of Western medicine NERD (gastroscopy within 6 months before enrollment); 2. meet the diagnostic criteria of stomach yin deficiency syndrome in traditional Chinese medicine; 3. Heartburn symptoms occurred for = 4 days in any consecutive 7 days during the screening period and no reflux esophagitis and Barrett's esophagus changes were found in gastroscopy during the screening period; 4.Gerd Q score = 8; 5.Did not take any medicine for NERD 2 weeks before enrollment; 6.age = 18 and = 70 years old regardless of gender; 7.understand and agree to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.24h esophageal impedance pH monitoring showed that patients with normal acid exposure were reflux hypersensitivity or functional heartburn; 2.patients with gastric diseases such as gastric malignant tumor gastroduodenal ulcer pyloric obstruction Zhuo AI syndrome etc; 3.patients with other esophageal diseases such as Barrett's esophagus\drug esophagitis eosinophilic esophagitis achalasia of cardia esophageal hiatal hernia etc; 4.patients with serious primary diseases or tumor history of heart brain liver kidney blood endocrine and other important systems; 5.patients with infectious hereditary metabolic endocrine autoimmune and other diseases; 6.patients with severe mental disorders and severe mental disorders (HAMD = 18 and/or HAMA = 14); 7.those who are allergic to any component of Western medicine omeprazole or traditional Chinese medicine used in this study; 8.women during pregnancy pregnancy or lactation; 9.those who have participated in or are participating in other clinical trials one month before enrollment or who must take other drugs during the trial; 10.HP positive patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of clinical treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptom score;GERD-HRQL;Salivary Pepsin Detection;heartburn VAS score;24h esophageal impedance pH monitoring;high resolution esophageal manometry;GerdQ score;heartburn 7 Likert score; | — |
Countries
China
Contacts
Public ContactBingduo Zhou
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed