MedTrace Logo

Clinical Efficacy Evaluation of Chaizhi Hewei Decoction in the Treatment of Non-Erosive Reflux Disease With Liver-Stomach Disharmony Syndrome

NCT07518420 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-08

No results posted yet for this study

Summary

This study focuses on patients with NERD (gastroesophageal reflux disease) and liver-gallbladder disharmony syndrome as its research subjects. It conducts a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the Chai Zhi He Wei formula in terms of symptom improvement, quality of life, and adverse reactions. On one hand, this research aims to enhance the level of evidence-based medicine for TCM syndrome differentiation and treatment of NERD. On the other hand, it seeks to reduce the dosage of PPIs (proton pump inhibitors) or discontinue their use, addressing the side effects caused by PPI overuse, and serving as a leading example for TCM clinical research. Lastly, the study aims to optimize the efficacy of Tongjiang granules and address potential safety concerns, such as diarrhea.

Conditions

  • Non-erosive Reflux Disease (NERD)

Interventions

DRUG

Chaizhi Hewei Decoction

Chaizhi Hewei Decoction Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks.

DRUG

Placebo

Placebo, 1 packet per dose, twice daily, to be taken 1 hour after breakfast and dinner, with a course duration of 4 weeks.

Sponsors & Collaborators

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-03-01
Completion
2028-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07518420 on ClinicalTrials.gov