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

NCT04324138 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-04-08

No results posted yet for this study

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.

Conditions

  • Nonerosive Reflux Disease

Interventions

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

Sponsors & Collaborators

  • Liaoning University of Traditional Chinese Medicine

    collaborator OTHER

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    collaborator OTHER

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • beihua zhang, M.D · Xiyuan Hospital of China Academy of Chinese Medical Sciences

  • guang bai, M.D · Liaoning University of Traditional Chinese Medicine

  • wei wang, M.M · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2021-12-01
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04324138 on ClinicalTrials.gov