KCT0008600
Not yet recruiting
未知
A clinical study on safety and efficacy of proton pump inhibitor with Yukgunja-tang for refractory gastroesophageal reflux disease: randomized, double-blind, double-dummy, parallel-group clinical trial
ConditionsDiseases of the digestive system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the digestive system
- Sponsor
- Kyunghee University-industry Cooperation Foundation
- Enrollment
- 86
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participants aged between 19 and 75 years.
- •2\. Participants diagnosed with gastroesophageal reflux disease (GERD), including erosive esophagitis or non\-erosive reflux disease.
- •3\. Participants who have received proton pump inhibitor therapy for at least 4 weeks but still experience typical symptoms of GERD (heartburn and acid regurgitation).
- •4\. Participants with a severity of dyspeptic symptoms measured on a 0\-100mm visual analogue scale of 40 points or higher.
- •5\. Participants who voluntarily agree to participate in this clinical trial and have signed the consent form.
Exclusion Criteria
- •1\. Participants with a history of hypersensitivity reactions (such as rash, urticaria, itching, etc.) to the components of the investigational drug or benzimidazole.
- •2\. Participants with the following conditions detected by upper gastrointestinal endoscopy: gastric ulcers (excluding erosion), ulcer stenosis, esophageal varices, eosinophilic esophagitis, gastrointestinal bleeding, Zollinger\-Ellison syndrome, Barrett's esophagus, esophageal stricture, or malignant tumors of the gastrointestinal tract.
- •3\. Participants diagnosed with functional dyspepsia, primary esophageal motility disorders, irritable bowel syndrome, or inflammatory bowel disease for the primary symptom.
- •4\. Participants presenting warning symptoms suggestive of malignancy (unintentional significant weight loss, recurrent vomiting, dysphagia, hematemesis, melena, etc.).
- •5\. Participants who have undergone surgeries that can affect gastric acid secretion, excluding procedures such as appendectomy, cholecystectomy, and hysterectomy (e.g., procedures involving esophageal surgery, acid secretion inhibition, gastric bypass surgery, etc.).
- •6\. Participants with a history of malignancy within 5 years before the screening date, except for cases other than gastrointestinal malignancies that have been cured without recurrence for at least 5 years from the date of determination.
- •7\. Participants diagnosed with severe liver disease, chronic kidney disease, or any severe renal dysfunction.
- •8\. Participants who have taken proton pump inhibitors, histamine receptor antagonists, antigastrinics, mucosal protective agents, cholinergic agents, anticholinergic agents, antispasmodics, acid suppressants, prokinetic agents, antipsychotic drugs, non\-steroidal anti\-inflammatory drugs, corticosteroids, anticoagulants within 2 weeks of receiving an investigational drug, or need continuous administration of these medications for the treatment of other diseases.
- •9\. Pregnant or lactating participants.
- •10\. Female participants of reproductive age who are expected to become pregnant during the clinical trial period (except for postmenopausal women who have been amenorrheic for at least 12 months or those who use medically accepted contraceptive methods such as hormonal therapy, intrauterine devices, surgical contraception, natural family planning, etc.).
Outcomes
Primary Outcomes
Not specified
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