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NCT Number: NCT07518420

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.

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Key information

Conditions

Non-erosive Reflux Disease (NERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Non-Erosive Reflux Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

Location contact

lin lv, Doctor

CONTACT

[email protected]

86-18811782728

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Patients with severe primary diseases of the cardiovascular, hepatic, renal, hematological, or respiratory systems, or malignant tumors.
  • Patients with mental disorders (e.g., schizophrenia, bipolar affective disorder, depression, anxiety, obsessive-compulsive disorder) and those with intellectual or language impairments.
  • Pregnant or breastfeeding women.
  • Patients allergic to any components of this preparation.
  • Patients currently taking medications that may affect the outcome of this study (e.g., proton pump inhibitors, potassium-competitive acid blockers, Tongjiang granules, etc.).
  • Patients currently participating in or having participated in other drug clinical trials within the past 4 weeks.
  • 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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Treatment and study plan

Chaizhi Hewei Decoction

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score

    Time frame: week 0 and the end of treatment at 4 weeks

Secondary outcomes

  1. Traditional Chinese Medicine (TCM) syndrome improvement status

    Time frame: week 0 and the end of treatment at 4 weeks

  2. SF-36 Scale Score

    Time frame: week 0 and the end of treatment at 4 weeks

  3. Patient-Reported Outcomes (PRO) Scale Scoring

    Time frame: week 0 and the end of treatment at 4 weeks

  4. Hospital Anxiety and Depression Scale (HAD) score

    Time frame: week 0 and the end of treatment at 4 weeks

    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.

Other outcomes

  1. Hematuria Metabolomics

    Time frame: week 0 and the end of treatment at 4 weeks

    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.

  2. Fecal Gut Microbiota Metagenomics

    Time frame: week 0 and the end of treatment at 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

lin lv, Doctor

CONTACT

[email protected]

86-18811782728

Sponsors and collaborators

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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