Clinical Efficacy Evaluation of Chaizhi Hewei Decoction in the Treatment of Non-Erosive Reflux Disease With Liver-Stomach Disharmony Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chaizhi Hewei Decoction, Placebo.
- Who it may be relevant to
- Registry conditions: Non-erosive Reflux Disease (NERD). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score [Time frame: week 0 and the end of treatment at 4 weeks]
Secondary outcome measures (4)
- Traditional Chinese Medicine (TCM) syndrome improvement status [Time frame: week 0 and the end of treatment at 4 weeks]
- SF-36 Scale Score [Time frame: week 0 and the end of treatment at 4 weeks]
- Patient-Reported Outcomes (PRO) Scale Scoring [Time frame: week 0 and the end of treatment at 4 weeks]
- Hospital Anxiety and Depression Scale (HAD) score [Time frame: week 0 and the end of treatment at 4 weeks]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiyuan Hospital of China Academy of Chinese Medical Sciences — Beijing
Identifiers
NCT: NCT07518420 · BJZYYB-2025-52