An interventional study of Chaizhi Hewei Decoction and Placebo in Non-erosive Reflux Disease (NERD), sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
46 studies on the registry are indexed under Non-Erosive Reflux Disease; 7 are open to participants now.
This study's planned enrollment of 66 is below the median of 170 across 33 interventional studies indexed under Non-Erosive Reflux Disease.
Browse Non-Erosive Reflux Disease studies →Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 43 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Placebo, 1 packet per dose, twice daily, to be taken 1 hour after breakfast and dinner, with a course duration of 4 weeks.
Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score
Time frame: week 0 and the end of treatment at 4 weeks
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
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.
Time frame: week 0 and the end of treatment at 4 weeks
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.
Time frame: 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.
Time frame: week 0 and the end of treatment at 4 weeks
Plan to share: No
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Xiyuan Hospital of China Academy of Chinese Medical Sciences