Status:
COMPLETED
Efficacy and Safety of Thread Embedding Acupuncture in Treating Gastroesophageal Reflux Disease
Lead Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Gastroesophageal reflux disease is a very common disease nowadays. Proton-pump inhibitors (PPIs) are the first-line treatment for this disease. However, the effectiveness of treatment with PPIs is sti...
Detailed Description
Patients with GERD diagnosed based on the GerdQ score who meet the inclusion criteria and do not meet the exclusion criteria will be included in the study. After randomization, patients will be divide...
Eligibility Criteria
Inclusion
- Male or female 18-60 years of age.
- Patients with total scores ≥ 8 on the Gastroesophageal Reflux Disease Questionnaire (GerdQ) and scores ≥ 2 for each symptom including heartburn and/or regurgitation.
- Ability to read, understand and provide informed consent.
- Currently not receiving any intervention to treat GERD.
Exclusion
- Have any current symptoms related to a structural disease that has been confirmed by endoscopy (e.g., gastrointestinal cancer, eosinophilic esophagitis, candida esophagitis, peptic ulcers, Zollinger-Ellison syndrome, pyloric stenosis, etc.).
- With known inflammatory bowel disease or other serious disease (hepatic, renal, respiratory, or cardiac disease) or rare genetic diseases (such as fructose intolerance, glucose-galactose malabsorption, saccharose-isomaltose deficiency), severe concomitant diseases, or a history of alcohol or drug abuse.
- Have severe dysphagia, hematemesis, weight loss, or hematochezia.
- A history of oesophageal and/or gastrointestinal surgery.
- Current use of drugs affecting treatment and evaluation of GERD including systemic glucocorticoids, nonsteroidal anti-inflammatory, calcium channel blockers, anticholinergics, bisphosphonates, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, tetracycline, HIV protease inhibitors, rifampin, potassium supplements, iron, quinidine, zidovudine, anticholinergic agents, alpha-adrenergic antagonists, β2-adrenergic agonists, benzodiazepines, barbiturates, dopamine, estrogens, progesterone, narcotic analgesics, nitrates, prostaglandins, theophylline.
- Are being treated with proton-pump inhibitors within the last 14 days, H2-receptor antagonists, or prokinetics within the last 10 days, intake of alginates or antacids within the last 3 days or using any traditional medicine to treat GERD within the last 2 weeks.
- A history of hypersensitivity reaction with PPIs (including their components), catgut or acupuncture or thread embedding acupuncture treatment.
- Are pregnant or breastfeeding.
- Are taking part in any other clinical trials.
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05353933
Start Date
May 4 2022
End Date
July 20 2022
Last Update
July 28 2022
Active Locations (1)
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1
University of Medical Center HCMC - Branch no.3
Ho Chi Minh City, Vietnam, 700000