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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-erosive Reflux Disease (NERD)
• Intervention / Treatment: Drug: Placebo; Drug: Chaizhi Hewei Decoction

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: lin lv, Doctor; Phone Number: 86-18811782728; Email: lushangshitou@qq.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100091
      • Xiyuan Hospital of China Academy of Chinese Medical Sciences
      • Contact: lin lv, Doctor; Phone Number: 86-18811782728; Email: lushangshitou@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Meet thediagnosis criteria for NERD;
2. GERD Q scale score >8 points;
3. Meet the criteria for the liver-stomach disharmony syndrome in traditional Chinese medicine;
4. Age between 18-70 years old;
5. Participants are informed and voluntarily sign the informed consent form. -

Exclusion Criteria:

1. Patients with active gastric or duodenal ulcers, gastritis with active bleeding, severe dysplasia of the gastric mucosa, or suspected malignancy; patients with achalasia or post-achalasia surgery; and patients with functional heartburn.
2. Patients with severe primary diseases of the cardiovascular, hepatic, renal, hematological, or respiratory systems, or malignant tumors.
3. Patients with mental disorders (e.g., schizophrenia, bipolar affective disorder, depression, anxiety, obsessive-compulsive disorder) and those with intellectual or language impairments.
4. Pregnant or breastfeeding women.
5. Patients allergic to any components of this preparation.
6. Patients currently taking medications that may affect the outcome of this study (e.g., proton pump inhibitors, potassium-competitive acid blockers, Tongjiang granules, etc.).
7. Patients currently participating in or having participated in other drug clinical trials within the past 4 weeks.

8. Patients with suspected or confirmed history of alcohol or substance abuse, anxiety, or depression; or, according to the investigator's judgment, other conditions that may reduce the likelihood of enrollment or complicate the enrollment process, such as frequent changes in work environment that may lead to loss of follow-up.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Placebo (a simulator of), 1 packet per dose, twice daily, to be taken 1 hour after breakfast and dinner, with a course duration of 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.
Active Comparator: Experimental Group; Chaizhi Hewei Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score	week 0 and the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traditional Chinese Medicine (TCM) syndrome improvement status		week 0 and the end of treatment at 4 weeks
SF-36 Scale Score		week 0 and the end of treatment at 4 weeks
Patient-Reported Outcomes (PRO) Scale Scoring		week 0 and the end of treatment at 4 weeks
Hospital Anxiety and Depression Scale (HAD) score	Scale Title: Hospital Anxiety and Depression Scale (HAD) Minimum Score: 0 Maximum Score:21 (for each subscale: Anxiety [A] and Depression [D]) Interpretation: Higher scores indicate worse outcomes (greater anxiety or depressive symptoms), with 0-7 = no symptoms, 8-10 = possible symptoms, 11-21 = definite symptoms.	week 0 and the end of treatment at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematuria Metabolomics	Outcome Measure Title: Changes in Plasma and Urine Metabolite Profiles Assessed by Untargeted Metabolomics Using Liquid Chromatography-Mass Spectrometry (LC-MS) Outcome Measure Description: Untargeted metabolomics analysis will be performed on plasma and urine samples collected from patients before and after treatment. The measurement tool is liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). The outcome measure is the relative abundance of detected metabolites. Unit of measure: Normalized peak intensity (arbitrary units) or relative ion count.	week 0 and the end of treatment at 4 weeks
Fecal Gut Microbiota Metagenomics	Outcome Measure Title: Changes in Gut Microbial Composition and Functional Genes Assessed by Shotgun Metagenomic Sequencing of Fecal Samples Outcome Measure Description: Shotgun metagenomic sequencing will be performed on fecal samples collected before and after treatment. The measurement tool is high-throughput next-generation sequencing (e.g., Illumina platform). The outcome measures include taxonomic relative abundance of microbial species, gene richness, and functional pathway abundances. Unit of measure: Relative abundance (percentage of total reads) and reads per kilobase per million (RPKM) for gene quantification.	week 0 and the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; Chaizhi Hewei Decoction; Liver-Stomach Disharmony Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; Non-Erosive Reflux Disease
• Other Study ID Numbers: BJZYYB-2025-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No