Non-erosive Reflux Disease
Conditions
Interventions
The control group:Treat with the placebo of Shugan Huazhi Fang (containing 5% of the original medicine) 1 sachet each time twice a day taken orally. The treatment course is 4 weeks and a follow-up is
The experimental group:Treat with Shugan Huazhi Fang 1 sachet each time twice a day taken orally. The treatment course is 4 weeks and a follow-up is conducted for 4 weeks (the follow-ups are carried o
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for NERD with liver depression and qi stagnation pattern. 2.Aged between 18 and 70 years. 3.Informed of the study content, agree to provide samples and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Co-existing organic pathologies of the digestive tract; 2.Other systemic disorders affecting gastrointestinal motility, such as hyperthyroidism, diabetes mellitus (duration >10 years), chronic renal insufficiency, severe anxiety or depression, nervous system diseases, or mild-to-moderate anxiety/depression requiring continuous use of psychotropic medications; 3.Regular use of psychotropic medications (e.g., anti-anxiety/antidepressant drugs) or acid-suppressive agents (e.g., PPIs) prior to enrollment, inability to discontinue these medications during the pre-enrollment washout period, or use of any non-study medications affecting trial outcomes during the study; 4.Severe comorbidities in cardiovascular, cerebrovascular, hepatic, renal, hematological, or pulmonary systems, or other life-threatening conditions (e.g., malignant tumors, AIDS); 5.Confirmed Helicobacter pylori (Hp) infection by C13/C14 urea breath test or gastroscopy within the past year, with ongoing infection or unresolved status at recruitment; 6.Pregnancy or lactation; 7.Known allergy or hypersensitivity to any component of the investigational product; 8.Current participation or participation in another interventional clinical trial within the past 4 weeks; 9.History of alcohol or substance abuse, or any other condition (e.g., unstable work environment) deemed by the investigator to increase the risk of dropout or compromise the study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) score for the main symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of the HAD (Hospital Anxiety and Depression Scale) scale;Serum SP (Substance P) concentration;Score of the SF-36 (Short Form 36-item Health Survey) scale;Serum 5 - HT (5 - Hydroxytryptamine) concentration;Score of the VSI (Vital Signs Index) scale;Serum CGRP (Calcitonin Gene - related Peptide) concentration;Serum MCT (Monocarboxylate Transporter) concentration;Integral of Traditional Chinese Medicine syndromes;Score of atypical symptoms and other symptoms;Score of the PRO (Patient-Reported Outcome) scale;Serum CRH (Corticotropin - releasing Hormone) concentration; | — |
Countries
China
Contacts
Public ContactWang Feng-yun
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed