Status:
UNKNOWN
Tongjiang Series Prescription Combined With PPIs Descending Ladder Withdrawal in Treating Nonerosive Reflux Disease
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Conditions:
Nonerosive Reflux Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Nonerosive Reflux Disease (NERD) is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred drug, have poor response, single target and poor acid inhibition effect i...
Detailed Description
Nonerosive Reflux Disease (NERD) accounts for about 70% of Gastroesophageal Reflux Disease (GERD), which is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred t...
Eligibility Criteria
Inclusion
- 1\. It meets the diagnostic criteria of nonerosive reflex disease(NERD)
- 2\. Patients with PPIs who are effective for more than 8 weeks and relapse after discontinuation
- 3\. Age between 18 and 70 years old
- 4\. It meets the diagnostic criteria of liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome of traditional Chinese medicine
- 5\. Patients have informed consent and are willing to receive corresponding treatment
Exclusion
- 1\. Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- 2\. There are other 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\. Patients with 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\. Pregnant and lactating women
- 5\. Patients with history of nervous system disease and mental disease
- 6\. People with a history of allergies to all the test drugs
- 7\. Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04340297
Start Date
June 15 2020
End Date
December 31 2021
Last Update
July 29 2020
Active Locations (1)
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1
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, China