A multicenter prospective randomized controlled trial: Comparison generic alginate Vs original alginate for symptoms controlled in the non-proton pump inhibitors responder GERD
- Conditions
- In patients with gastroesophageal reflux disease, despite taking proton pump inhibitors But only 25.7% of symptoms could be controlled in 7 days and only 35.9% of GERD patients were found to have no heartburn symptoms over 28 days. Patients with GERD are chronic and affect their quality of life worse compared to normal people. which often affects sleep decreased vitality more pain in the body impaired sexual feelings and more anxiety.GERD
- Registration Number
- TCTR20230119007
- Lead Sponsor
- Dr. Kawin Tangvoraphonkchai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 162
Thai patients aged 18 years and older with a diagnosis of gastroesophageal reflux disease were treated with standard-dose proton pump inhibitors for at least 4 weeks but did not respond to treatment. The criteria for GERD diagnosis are: Typical symptoms of GERD include heartburn and belching at least twice a week. with symptoms continually for 1 month. or with a score greater than or equal to 8 using a standardized questionnaire to help diagnose GERD. (Gastroesophageal Reflux Disease Questionaire (GerdQ)). If the patient has warning symptoms (Alarm symptoms), they must do EGD before.
Psychiatric problems, Currently using prokinetic or H2 blocker or PCAB or alginate drug, Antiplatelet or NSAIDs using, Pregnancy, Previous surgery of esophagus, Alginate allergy, The patient in question is unable to listen or answer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of response patients Day 7 and Day 28 Different of number of response patient
- Secondary Outcome Measures
Name Time Method Symptom free days Day 28 Proportion,Adverse effect Day 28 Proportion