None listed
Conditions
Interventions
Drug : The investigational product for the clinical trial is divided into Study group and control group.
-Study group: Gluta-S Tab(active drug) 2 tablets + Gasmotine Tab. 5 mg (placebo) one tablet
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 years or older at the time of the screening visit. 2) Subjects who diagnosed with functional dyspepsia according to the Rome IV criteria during the screening visit, meeting at least one of the following conditions: - Postprandial Distress Syndrome (PDS): Unpleasant postprandial fullness or early satiety that began at least six months prior and has occurred at least three ays per week in the past three months. -Epigastric Pain Syndrome (EPS): Unpleasant epigastric pain or burning that began at least six months prior and has occurred at least one day per week in the past three months. -Both PDS and EPS present simultaneously. 3) No disease that could explain dyspeptic symptoms, as confirmed by an upper gastrointestinal endoscopy performed during screening. 4) At the time of screening, based on the past two weeks, the participant must have reported at least one of the eight functional dyspepsia symptoms assessed by the Nepean Dyspepsia Index-Korean version (NDI-K) (epigastric pain, epigastric discomfort, epigastric burning, early satiety, postprandial fullness, epigastric pressure, epigastric bloating, nausea) with: A symptom severity score of 3 or higher ("moderate" or worse)or a bothe rsomeness score of 3 or higher ("severe" or worse). 5) Subjects who voluntarily agreed to participate in the study and signed the informed consent form
Exclusion criteria
Exclusion criteria: 1) Subject who have active or healing peptic ulcers (gastric ulcers, esophageal ulcers, duodenal ulcers), reflux esophagitis of LA-A or higher, stomach cancer, esophageal cancer, pancreatic diseases (pancreatitis, pancreatic cancer, etc.), biliary tract disease (but asymptomatic cholelithiasis, full recovery after cholecystectomy can be selected), inflammatory bowel disease, etc. within six months 2) Subject with gastrointestinal bleeding, mechanical intestinal obstruction, perforation, etc 3) Subject who have an organic cause of gastroparesis (e.g., diabetic gastroparesis, etc.) 4) A Subject with irritable bowel syndrome 5) Subject who have undergone surgery that may affect the movement of the gastrointestinal tract (such as laparoscopic surgery of the gastrointestinal tract, Open surgery, etc.) (However, if the patient fully recovered after appendectomy, cholecystectomy, or hemoptysis can be selected.) 6) A severely mentally ill Subject, alcoholic, drug dependent 7) Subjects with liver, kidney, cardiovascular, respiratory, endocrine, and central nervous system diseases that may affect the performance and outcome of clinical trials 8) Screening examination includes at least one of the following ? HbA1c > 9% (people with uncontrolled diabetes) ? Subject whose AST or ALT exceeds the upper limit of normal three times ? Subject whose serum creatine is more than 1.5 times the upper limit of normal ? Systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg (Subject with uncontrolled hypertension) 9) Subjects who are taking medications that may affect the evaluation of the efficacy of the investigational product, including gastrointestinal motility regulators, histamine (H2) receptor antagonists, proton pump inhibitors, systemic nonsteroidal anti-inflammatory drugs, anticholinergics, adrenocorticotropic hormones, antidepressants, aspirin or antiplatelet agents at doses exceeding 100 mg, and anticoagulants. Subjects may be enrolled after a wash-out period of at least 2 weeks (±4 days) prior to the randomization visit. Administration of these medications for the purpose of upper gastrointestinal endoscopy is permitted without a wash-out period. 10) A Subject who has received or is administering other clinical trial drugs within 4 weeks as of the screening visit 11) A Subject who has a history of hypersensitivity reactions to clinical trial drugs (including ingredients) and similar drugs 12) Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption, etc 13) Pregnant or breast-feeding women 14) A Subject who disagrees with contraception by himself or his/her spouse or partner during the clinical study with medically acceptable appropriate contraception* * Medically acceptable appropriate contraception: hormonal contraception (subcutaneous grafts, injections, oral contraceptives, etc.), intrauterine devices (copper loops, hormone-containing intrauterine systems), tubular resection, tubular ligation, hysterectomy, vasectomy, double blocking (combined use of male condoms, cervical caps, contraceptive septums, contraceptives, and contraceptive sponges), single blocking with apoptosis 15) In addition to the above items, a Subject deemed inappropriate to participate in the study under the judgment of the Study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score change of NDI-K 8 functional dyspepsia symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Total score change of NDI-K 8 functional dyspepsia symptoms ;Improvement of symptoms;Overall evaluation of study subjects | — |
Countries
Korea, Republic of
Contacts
Public ContactKwang Jae Lee
Ajou University Hospital
Outcome results
None listed