Non-erosive Reflux Disease (NERD)
Conditions
Keywords
Chaizhi Hewei Decoction, Liver-Stomach Disharmony Syndrome, randomized controlled trial
Brief summary
This study focuses on patients with NERD (gastroesophageal reflux disease) and liver-gallbladder disharmony syndrome as its research subjects. It conducts a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the Chai Zhi He Wei formula in terms of symptom improvement, quality of life, and adverse reactions. On one hand, this research aims to enhance the level of evidence-based medicine for TCM syndrome differentiation and treatment of NERD. On the other hand, it seeks to reduce the dosage of PPIs (proton pump inhibitors) or discontinue their use, addressing the side effects caused by PPI overuse, and serving as a leading example for TCM clinical research. Lastly, the study aims to optimize the efficacy of Tongjiang granules and address potential safety concerns, such as diarrhea.
Interventions
DRUGChaizhi Hewei Decoction
Chaizhi Hewei Decoction Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks.
DRUGPlacebo
Placebo, 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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
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 | week 0 and the end of treatment at 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Traditional Chinese Medicine (TCM) syndrome improvement status | week 0 and the end of treatment at 4 weeks | — |
| SF-36 Scale Score | week 0 and the end of treatment at 4 weeks | — |
| Patient-Reported Outcomes (PRO) Scale Scoring | week 0 and the end of treatment at 4 weeks | — |
| Hospital Anxiety and Depression Scale (HAD) score | week 0 and the end of treatment at 4 weeks | Scale Title: Hospital Anxiety and Depression Scale (HAD) Minimum Score: 0 Maximum Score:21 (for each subscale: Anxiety \[A\] and Depression \[D\]) Interpretation: Higher scores indicate worse outcomes (greater anxiety or depressive symptoms), with 0-7 = no symptoms, 8-10 = possible symptoms, 11-21 = definite symptoms. |
Countries
China
Contacts
CONTACTlin lv, Doctor
Outcome results
None listed