A randomized controlled clinical trial of Tongjiang Jieyu Decoction in the treatment of non-erosive gastroesophageal reflux disease overlapping functional dyspepsia
- Conditions
- non-erosive gastroesophageal reflux disease overlapping functional dyspepsia
- Registration Number
- ITMCTR2024000138
- Lead Sponsor
- Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method