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Efficacy and safety of Jiang-Wei-An-Zhong granules based on traditional Chinese medicine Tongjiang theory in the treatment of Refractory Gastroesophageal Reflux Disease: protocol for a randomised double-blind placebo-controlled clinical trial.

Based on traditional Chinese medicine Tongjiang theory to investigate the role of Jiang-Wei-An-Zhong granules in enhancing esophageal motility for the treatment of the Refractory Gastroesophageal Reflux Disease: a randomized double-blind placebo-controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000663
Enrollment
Unknown
Registered
2025-04-06
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Gastroesophageal Reflux Disease

Interventions

control group:Take Simulated Traditional Chinese Medicine granules (5% Jiang-Wei-An-Zhong granules + 95% dextrin) +Western Medicine (Rabeprazole capsules 20 mg).
experimental group:Take Chinese herbal granules(Jiang-Wei-An-Zhong granules)+simulated Western medicine group (using capsules that resemble rabeprazole filled with dextrin)

Sponsors

Fangshan Hosptial of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Western medicine diagnoses match rGERD; (2) Traditional Chinese medicine identifies it as Liver Stomach Stasis Heat Type Syndrome; (3) Participants must be between 18 and 75 years old; (4) Individuals must voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who have previously taken a double dose of Rabeprazole for eight weeks. (2) Recent history of medication use affecting the gastrointestinal tract such as glucocorticoids aspirin and calcium channel blockers. (3) Individuals with organic upper gastrointestinal diseases such as gastric ulcers or gastric cancer and those with primary esophageal motility disorders. (4) Patients with severe primary diseases affecting other systems. (5) Individuals with a history of surgeries in the gastroesophageal region. (6) Pregnant or breastfeeding women and individuals with legally defined disabilities (such as blindness deafness mutism intellectual disabilities or mental disorders). (7) Participants with allergies intolerances or contraindications related to the medication involved in this trial. (8) Patients concurrently enrolled in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
Utilize the symptom section A (heartburn + reflux) total score of the GerdQ scale. ;Recurrence rates in half a year;

Secondary

MeasureTime frame
Self-Rating Depression Scale(SDS);Traditional Chinese Medicine Symptom ClinRO Evaluation Scale;Pittsburgh Sleep Quality Index(PSQI);Analysis of Gut Microbiome Composition;Resting and residual pressure of the upper esophageal sphincter;Distal Latency (DL);Metabolomics;Reflux number;Mean nocturnal baseline impedance (MNBI);RDQ Scale;Serum VIP;Resting and residual pressure of the lower esophageal sphincter;Distal contractile integral (DCI);Self-Rating Anxiety Scale (SAS);Esophagogastric junction-contractile integral(EGJ-CI);Integrated relaxation pressure (IRP);Serum Gastrin;Serum 5-hydroxytryptamine(5-HT);Acid exposure time (AET);Post-reflux swallow-induced peristaltic wave (PSPW);

Countries

China

Contacts

Public ContactBoyi Jia

Fangshan Hosptial of Beijing University of Chinese Medicine

jiaboyiwilliam@163.com+86 156 0005 2896

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026