Efficacy evaluation study on the therapeutic effect of Wenpi Qingwei Granule on non erosive reflux disease

Phase 1

Recruiting

• Conditions: onerosive Reflux Disease

• Registration Number: ITMCTR2000003338
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of visual analogue (VAS) score of reflux symptoms and heartburn;

Secondary Outcome Measures

Name	Time	Method
Change of patient ported outcome (PRO) for chronic gastrointestinal disease scale score;Change of self-rating anxiety scale (SAS) score;Change of traditional Chinese Medicine syndrome score;Change of EuroQol- 5 Dimension scale score;Change of self-rating depression scale (SDS) score;The secondary symptoms of Non-cardiogenic chest pain, epigastric pain, upper abdominal burning sensation, belching, cough, asthma, Pharyngeal different feeling were recorded;Change of gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale score;