A clinical study on safety and efficacy of proton pump inhibitor with Yukgunja-tang for refractory gastroesophageal reflux disease
- Conditions
- Diseases of the digestive system
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 86
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.
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.).
11. Participants with a history of alcohol addiction or drug abuse.
12. Participants with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
13. Participants currently receiving Atazanavir or Rilpivirine.
14. Participants with chronic conditions that are poorly controlled despite appropriate treatment (e.g., hypertension, diabetes, edema) that pose a threat to life, require hospitalization, lead to significant physical disabilities, or interfere with daily activities.
15. Participants who have participated in another clinical trial within 30 days prior to the date of written consent.
16.Participants who have taken herbal/traditional medicine products that can affect gastric acid secretion and the gastrointestinal system or those who received traditional Korean medicine treatments (acupuncture, cupping, etc.) within 2 weeks prior to the initiation of the investigational drug administration.
17. Participants who are unable to participate or receive treatment in the clinical trial due to severe mental disorders, illiteracy, etc.
18. Participants with clinically significant abnormalities
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency Scale for the Symptoms of GERD (FSSG) score
- Secondary Outcome Measures
Name Time Method Proportion of treatment responders;Reflux Disease Questionnaire (RDQ) score;Reflux Symptom Score (RSS);Damum questionnaire (DQ) score;Spleen Qi Deficiency questionnaire (SQDQ) score;GERD-Health Related Quality of Life (GERD-HRQL) score;Safety(adverse events);Overall Treatment Evaluation;Safety(blood and urine tests);Safety(vital signs)