Gastroesophageal reflux disease
Conditions
Interventions
Experimental group:Three-Dimensional Acid Suppression Formula + Omeprazole Enteric-Coated Capsules Placebo Three-Dimensional Acid Suppression Formula: Coptis rhizome 6g, Pinellia tuber 12g, Cinnamomum
Control group:Triple Acid Suppression Formula Placebo + Omeprazole Enteric-Coated Capsules Triple Acid Suppression Formula Placebo: Contains Triple Acid Suppression Formula diluted to 10% active ingre
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets Western medical diagnostic criteria for gastro-oesophageal reflux disease (GERD) (gastroscopy performed within 6 months prior to enrolment); (2) Meets Traditional Chinese Medicine diagnostic criteria for mixed cold-heat syndrome; (3) No medication for GERD taken within 2 weeks prior to enrolment; (4) Aged =18 years and =70 years, gender unrestricted; (5) Understands and consents to participate in this study, having signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with high-sensitivity reflux or functional heartburn who exhibit normal acid exposure on 24-hour oesophageal pH-impedance monitoring; (2) Those with Barrett's oesophagus identified by gastroscopy; (3) Those with concomitant gastric disorders such as gastric or duodenal ulcer, pyloric obstruction, or Zollinger-Ellison syndrome; (4) Those with concomitant other oesophageal disorders such as drug-induced oesophagitis, eosinophilic oesophagitis, achalasia, or hiatal hernia; (5) Patients with severe primary diseases or a history of tumours affecting major systems including cardiac, cerebral, hepatic, renal, haematological, or endocrine systems; (6) Patients with severe psychiatric disorders or significant mental health conditions (HAMD = 18 and/or HAMA = 14); (7) Individuals with known hypersensitivity to omeprazole (the Western medicine used in this study) or any component of the Chinese herbal medicine; (8) Women attempting to conceive, pregnant, or breastfeeding; (9) Participants who have enrolled in or are currently enrolled in another clinical trial within the preceding month, or who must take other medications during the trial period; (10) Patients with Helicobacter pylori (HP) positive infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate based on clinical symptom scoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reflux Diagnostic Questionnaire (RDQ);Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score;Gastroesophageal Reflux Disease Health-Related Quality of Life Scale (GERD-HRQL);Salivary pepsin test;24-hour oesophageal pH-impedance monitoring;Gastroscopy;Four-item gastric function test; | — |
Countries
China
Contacts
Public ContactBingduo Zhou
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Outcome results
None listed