Skip to content

Clinical study of Tongyang Xuanbi recipe in the treatment of chest pain Associated with gastroesophageal reflux disease with hypofunction of Yang Qi in chest:A randomized ,double-blind,placebo-controlled trial

Clinical study of Tongyang Xuanbi recipe in the treatment of chest pain Associated with gastroesophageal reflux disease with hypofunction of Yang Qi in chest

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059248
Enrollment
Unknown
Registered
2022-04-27
Start date
2022-05-09
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

Gastroesophageal reflux disease

Interventions

Experimental group:Tongyang Xuanbi pilulas combined with rabeprazole capsules
Control group:Tongyang Xuanbi pilulas placebo combined with rabeprazole capsules

Sponsors

Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of chest pain associated with gastroesophageal reflux disease (electronic gastroscopy within 6 months before enrollment); 2. TCM syndrome differentiation of patients belongs to hypofunction of Yang Qi in chest; 3. Patients who had not taken medicine for this disease,such as acid suppressants or gastrointestinal motility drugs 2 weeks before enrollment; 4. Aged 18 to 70 years, regardless of gender; 5. Patients who understand and agree to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Chest pain caused by other noncardiac causes (chest wall disease, respiratory disease, mediastinal disease, psycho-psychiatric factors and other primary esophageal dynamic diseases such as achalasia from cardia, diffuse esophageal spasm, nutcracker esophagus, lower esophageal sphincter hypertension, etc.); 2.Gastroscopy results indicated patients have one of the following diseases: peptic ulcer, history of gastroesophageal and duodenal surgery, Zollinger-Ellison syndrome, pyloric obstruction,scleroderma,drug esophagitis, fungal esophagitis, gastrointestinal malignancy; 3.Patients with serious primary diseases of heart, brain, liver, lung, kidney, blood and endocrine system, which have not been effectively controlled, and patients with severe mental illness; 4.Patients who cannot take medication during pregnancy preparation, pregnancy or lactation; 5.Allergic to rabeprazole or any of the ingredients in Traditional Chinese medicine used in this study; 6.Patients who have participated in or are participating in other clinical trials 1 month before enrollment.

Design outcomes

Primary

MeasureTime frame
Clinical Symptom Score;Visual Analogue Scale, VAS;

Secondary

MeasureTime frame
Global Pain Scale, GPS;Brief Pain Inventory short form;Medical Outcomes Study SF-36 Questionnaire;Electronic Gastroscopy;

Countries

China

Contacts

Public ContactZhou Bingduo

Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

bingduozhou@163.com+86 21 65161782

Outcome results

None listed

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