Non-erosive gastroesophageal reflux disease (Liver-stomach disharmony syndrome)
Conditions
Interventions
Experimental Group:Take Si Mo Tang oral liquid, 2 vials (20ml) each time, 3 times a day, for 4 weeks.
Control Group:Take the Si Mo Tang oral solution placebo, 2 bottles (20ml) each time, three times daily, for four weeks.
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Participants who meet the diagnostic criteria for Non-erosive gastroesophageal reflux disease (NERD); 2) Participants who meet the diagnostic criteria for Liver-Gallbladder disharmony syndrome in Traditional Chinese Medicine (TCM); 3) Have had heartburn and regurgitation, the two typical symptoms, for at least 3 months prior to screening; 4) Have a GerdQ score total of =8 points and <30 points; 5) Aged between 18 and 70 years (inclusive); 6) Be compliant, able to undergo related treatments and various physical and chemical examinations; 7) Be informed, agree to participate in this clinical trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Reflux esophagitis (RE) and Barrett's esophagus; 2) Individuals with positive Helicobacter pylori (HP) infection; 3) Organic diseases of the esophagus and stomach; 4) Patients presenting with "alarm symptoms" such as dysphagia, hematemesis, melena, or weight loss, or those already diagnosed with tumors; 5) Individuals with structural abnormalities of the digestive tract or other organic diseases that may cause reflux-related symptoms (e.g., hiatal hernia, achalasia, diabetic gastroparesis, eosinophilic esophagitis, etc.); 6) Individuals currently using or requiring continuous use of medications that may affect esophageal and gastrointestinal function; 7) Individuals with severe primary diseases or malignant tumors in systems such as cardiovascular, cerebrovascular, hepatic, renal, hematological, respiratory, hematopoietic, or immune systems; 8) Individuals with mental illness or intellectual disabilities; 9) Laboratory tests indicating abnormal liver or kidney function: ALT, AST >1.5 times the upper limit of normal, SCr > upper limit of normal; 10) Pregnant or breastfeeding women, or individuals with menopausal syndrome; 11) Individuals with a history of allergies or hypersensitivity to any components of the study drug; 12) Individuals who have participated in other drug clinical trials within the past three months or are currently participating in other drug clinical trials; 13) Individuals with suspected or confirmed history of alcohol or substance abuse; 14) Other situations deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-point Likert scale effectiveness evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall symptoms (typical and atypical symptoms) efficacy;The disappearance rate, significant improvement rate, and improvement rate of single symptoms in typical symptoms, atypical symptoms, or extraesophageal symptoms.;Efficacy of Liver-Gallbladder disharmony syndrome and symptom efficacy;GERD Q Score Questionnaire (GERDQ), GERD Health-Related Quality of Life Questionnaire (GERD-HRQL) Scoring Efficacy Assessment; | — |
Countries
China
Contacts
Public ContactHuizhen Li
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed