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

NCT07518420 | Not Yet Recruiting DMC

• 1 other identifier: BJZYYB-2025-52
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Chaizhi Hewei Decoction; Liver-Stomach Disharmony Syndrome; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score

  week 0 and the end of treatment at 4 weeks

Secondary Outcomes (4)

• 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

  week 0 and the end of treatment at 4 weeks

Other Outcomes (2)

• Hematuria Metabolomics

  week 0 and the end of treatment at 4 weeks

• Fecal Gut Microbiota Metagenomics

  week 0 and the end of treatment at 4 weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Experimental Group

ACTIVE COMPARATOR

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

Drug: Chaizhi Hewei Decoction

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

lin lv, Doctor

CONTACT

86-18811782728; lushangshitou@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 8, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)