Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine; Liaoning University of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

1. Subjects diagnosed with non-erosive reflux disease

2. Subjects who have a medical history of PPI with poor therapeutic effect

3. Subjects aged between 18 and 70 years

4. Subjects diagnosed with spleen deficiency damp-heat syndrome 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. Pregnant or lactating women

5. Subjects who have a history of nervous system disease and mental disease

6. Subjects who have 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