None listed
Conditions
Interventions
Dietary Supplement : Take test food (600 mg/tab as SPB-201) or control food (600 mg/tab) twice a day for 8 weeks, 1 tablet once a day with water
Sponsors
Sungkyunbiotech
G&P Bioscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who is 19 years of age or older and 70 years of age or younger 2) A person diagnosed with functional dyspepsia 3) Those who have at least 4 of the 10 symptoms in the GIS questionnaire and have a total score of 12 or more 4) Where it is possible to bring the result of gastroscopy performed within 6 months, and the result sheet determines that there is no organic disease 5) A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.
Exclusion criteria
Exclusion criteria: 1) Severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, mental, infectious disease, and malignant tumor can participate in the test at the discretion of the tester. 2) A person who has a history of peptic ulcer or other diseases (such as colostrum disease) that may cause gastrointestinal symptoms within 6 months of visiting 1 3) Those with gastrointestinal surgical history (excluding appendectomy and hemorrhoids) 4) A person with a history of digestive malignancies 5) Those who have taken H2 receptor blockers, anticholinergics (muscarin receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosa protectors, gastrointestinal motility boosters, and other health-related functional foods within 2 weeks of visit 1 6) A person who has taken drugs that can cause gastritis, such as adrenocorticotropic hormone drugs, nonsteroidal anti-inflammatory drugs, aspirin, erythromycin, and antidepressants, within 2 weeks of visiting 1 7) A person with a history of drug addiction 8) Those with alcohol consumption habits exceeding the average 30g/day for men (about 3 beers and 3 soju) and 20g/day for women (about 2 beers and 2 soju) per week in the drinking habit survey over the past month 9) Patients with uncontrolled hypertension (systolic blood pressure of 160mmHg or diastolic blood pressure of 100mmHg or more, test subjects after 10 minutes of rest) 10) Patients with uncontrolled diabetes (abdominal blood sugar greater than 180 mg/dL) 11) A person whose creatine is more than twice the upper limit of the normal administrative agency 12) Those whose AST (GOT) or ALT (GPT) is at least three times the upper limit of the normal authority 13) Those whose amylase and lipase are more than twice the upper limit of normal levels of the agency (but abnormal values can be excluded at the discretion of the researcher) 14) Those whose TSH is 0.1 µIU/mL or less, or 10 µIU/mL or more 15) Those who are sensitive to or allergic to food ingredients for human application tests 16) Pregnant or nursing mothers or those who plan to become pregnant during the period of this human body application test 17) A person who has participated in other interventional clinical trials (including human application tests) within three months of visiting 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test 18) A person deemed by a tester to be inappropriate for this human body application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointinal Symptom Rating Scale (GSRS) Upper abdominal symptom score | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointinal Symptom Rating Scale (GSRS);Gastrointestinal symptoms questionnaire (GIS);Indigestion questionnaire (excluding NDI-K, quality of life);Quality of Life Questionnaire (FD-QoL) related to poor mobility;Blood Biomarkers (ESR, CRP) | — |
Countries
Korea, Republic of
Contacts
Public ContactByoung Duck Han
Korea University Anam Hospital
Outcome results
None listed