Status:
UNKNOWN
Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Liaoning University of Traditional Chinese Medicine
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Conditions:
Nonerosive Reflux Disease
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patie...
Detailed Description
Nonerosive reflux disease (NERD), representing about 70% of gastroesophageal reflux disease, is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have...
Eligibility Criteria
Inclusion
- Subjects diagnosed with non-erosive reflux disease
- Subjects who have a medical history of PPI with poor therapeutic effect
- Subjects aged between 18 and 70 years
- Subjects diagnosed with spleen deficiency damp-heat syndrome of traditional Chinese medicine
- Subjects who voluntarily signed written informed consent form
Exclusion
- Subjects who have active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- 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
- 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
- Pregnant or lactating women
- Subjects who have a history of nervous system disease and mental disease
- Subjects who have a history of allergies to all the test drugs
- Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04324138
Start Date
July 15 2020
End Date
December 31 2021
Last Update
April 8 2021
Active Locations (1)
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1
Xiyuan Hospital
Beijing, Beijing Municipality, China, 100091