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A randomized controlled clinical trial of Tongjiang Jieyu Decoction in the treatment of non-erosive gastroesophageal reflux disease overlapping functional dyspepsia

A randomized controlled clinical trial of Tongjiang Jieyu Decoction in the treatment of non-erosive gastroesophageal reflux disease overlapping functional dyspepsia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000138
Enrollment
Unknown
Registered
2024-07-30
Start date
2024-08-05
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

non-erosive gastroesophageal reflux disease overlapping functional dyspepsia

Interventions

control group:Rabeprazole Sodium Enteric-coated Tablet
treatment group:Tongjiang Jieyu Decoction

Sponsors

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: Meanwhile meet the western medical diagnosis of NERD, FD and Chinese medicine diagnostic criteria, and have the typical gastro-oesophageal reflux symptoms for more than 1 month. 2: Between 18 and 75 years old. 3: Patients who demonstrate good compliance, voluntarily and autonomously cooperate with treatment and follow-up, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1: Patients with cardiogenic chest pain, gastric or duodenal ulcers, upper gastrointestinal malignancies, acute upper gastrointestinal bleeding, biliary diseases, or those with lesions diagnosed by endoscopy or pathology. 2: Patients with Helicobacter pylori infection, achalasia, pyloric obstruction, Zollinger-Ellison syndrome, post-gastroesophageal or duodenal surgery, other laboratory findings indicating organic diseases causing the condition, or other systemic diseases. 3: Patients with esophageal lesions caused by other reasons, such as fungal esophagitis, drug-induced esophagitis, immune-related esophagitis, eosinophilic esophagitis, esophageal cancer, etc. 4: Patients with severe primary cardiovascular, cerebrovascular, liver, kidney, endocrine, or hematological diseases, or other serious illnesses affecting survival. 5: Pregnant or lactating women, and those planning pregnancy within the next year. 6: Patients known to be allergic to the traditional Chinese or Western medicines used in this study or those who have previously experienced liver or kidney function impairment due to traditional Chinese medicine. 7: Patients who have taken acid-suppressing, prokinetic, or other medications that may affect the study results within the last two weeks. 8: Patients suspected of or with a history of alcohol or drug abuse, or other conditions that might reduce the likelihood of enrollment or complicate participation. 9: Patients with legal disabilities or mental illnesses as defined by law. 10: Patients currently participating in other drug clinical studies.

Design outcomes

Primary

MeasureTime frame
Complete resolution of typical NERD symptoms (heartburn, reflux);

Secondary

MeasureTime frame
Gastric emptying rate;Recurrence rate;Number of days to complete relief of typical symptoms (heartburn, reflux) ratio;Nepean Dyspepsia Index, NDI;Clinical symptom scoring in traditional Chinese medicine;

Countries

China

Contacts

Public ContactWang Shaoli

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

drshaoliwang@163.com+86 134 6635 8638

Outcome results

None listed

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