Efficacy and Safety of Wenpi Qingwei Granules in Patients With Nonerosive Reflux Disease: a Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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

•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

发起方

Guangdong Provincial Hospital of Chinese Medicine