Non-erosive reflux disease
Conditions
Interventions
Experimental Group:Zhiyuan Weigan Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks.
Control Group: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.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet thediagnosis criteria for NERD; 2. GERD Q scale score >8 points; 3. Meet the criteria for the liver-stomach disharmony syndrome in traditional Chinese medicine; 4. Age between 18-70 years old; 5. Participants are informed and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with active gastric or duodenal ulcers, gastritis with active bleeding, severe dysplasia of the gastric mucosa, or suspected malignancy; patients with achalasia or post-achalasia surgery; and patients with functional heartburn. 2. Patients with severe primary diseases of the cardiovascular, hepatic, renal, hematological, or respiratory systems, or malignant tumors. 3. Patients with mental disorders (e.g., schizophrenia, bipolar affective disorder, depression, anxiety, obsessive-compulsive disorder) and those with intellectual or language impairments. 4. Pregnant or breastfeeding women. 5. Patients allergic to any components of this preparation. 6. Patients currently taking medications that may affect the outcome of this study (e.g., proton pump inhibitors, potassium-competitive acid blockers, Tongjiang granules, etc.). 7. Patients currently participating in or having participated in other drug clinical trials within the past 4 weeks. 8. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastroesophageal Reflux Disease Questionnaire (GERD Q) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine (TCM) syndrome improvement status;SF-36 Scale Score;Patient-Reported Outcomes (PRO) Scale Scoring;Hospital Anxiety and Depression Scale (HAD) score; | — |
Countries
China
Contacts
Public Contactlin,lv
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed