Nonerosive Reflux Disease
Conditions
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with non-erosive reflux disease 2. Subjects aged between 18 and 70 years 3. Subjects diagnosed with syndrome of mixed cold and heat of traditional Chinese medicine 5. Subjects who voluntarily signed written informed consent form
Exclusion criteria
Exclusion criteria: 1. Subjects who have active peptic ulcer, gastrointestinal hemorrhage,severe dysplasia of gastric mucosa or suspected malignant change,achalasia or postoperative achalasia 2. Subjects who have organic diseases of the digestive system (such as acute and chronic pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression), nervous system diseases, etc 3. Subjects who have severe organ diseases such as heart, liver and kidney (such as ALT, AST more than 2 times of normal value),hematopoietic system diseases and tumors 4.Subjects who have a history of anti reflux and other upper gastrointestinal operations 5.Pregnant or lactating women 6.Subjects who have a mentally ill, mentally and linguistically disabled, unable to describe their own symptoms and cooperat 7.Subjects who suspect or have a history of alcohol or drug abuse, or according to the judgment of the researcher, have other circumstances that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment and other situations that are likely to cause lost visits 8. Subjects who have a history of allergies to all the test drugs 9. Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of visual analogue (VAS) score of reflux symptoms and heartburn; | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary symptoms of Non-cardiogenic chest pain, epigastric pain, upper abdominal burning sensation, belching, cough, asthma, Pharyngeal different feeling were recorded;Change of traditional Chinese Medicine syndrome score;Change of gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale score;Change of patient ported outcome (PRO) for chronic gastrointestinal disease scale score;Change of self-rating anxiety scale (SAS) score;Change of self-rating depression scale (SDS) score;Change of EuroQol- 5 Dimension scale score; | — |
Countries
China
Contacts
Public ContactHuang Shaogang
Guangdong Hospital of traditional Chinese Medicine
Outcome results
None listed