NCT04324138

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

Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease:a Multicenter,Randomized, Double-blind, Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 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. NERD is the result of multifactorial pathogenicity. The reflux symptoms not only related to acid reflux, but also related to alkali, gas, mixed reflux, etc. The theory of Tongjiang put forward by Academician Dong Jianhua.Under the guidance of Academician Dong Jianhua, the research team create a prescription Jianpi Qinghua granule for treating NERD with spleen deficiency and damp-heat syndrome. 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 based on a a multicenter,randomized, double-blind, placebo-controlled clinical trial. On the basis of previous work, the project plans to establish sub centers in 3 Chinese hospitals, including78 patients with NERD and spleen deficiency and damp-heat syndrome. The therapeutic effects were evaluated from the following aspects: the VAS score of reflow and heartburn, the rate of discontinuation of antacids, the rate of recurrence of NERD symptoms, the score of TCM syndromes and the improvement of gastrointestinal function.

Conditions

• Nonerosive Reflux Disease

Interventions

Type	Name	Description
DRUG	Jianpi Qinghua granules	3 times a day and 1 hour after a meal, for 4 weeks
DRUG	Jianpi Qinghua placebo granules	3 times a day and 1 hour after a meal, for 4 weeks

Timeline

• Start date: 2020-07-15
• Primary completion: 2021-12-01
• Completion: 2021-12-31
• First posted: 2020-03-27
• Last updated: 2021-04-08

Locations

1 site across 1 country: China