Study for the efficacy and safety of "BST104" in mild to moderate functional dyspepsia subjects

A single-center, randomized, double-blind, Placebo-controlled, Intervention study for the efficacy and safety of "BST104" in mild to moderate functional dyspepsia subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004085

Enrollment

Registered

2019-06-21

Start date

2017-02-27

Completion date

Unknown

Last updated

2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Treatment group: Morning and evening each 1 tablet, total of 2 tablets each day (250 mg as Lonicera japonica Thunb. (Caprifoliaceae) extract) Control group: Morning and evening ea

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult male and female over 19 years old Patients diagnosed with functional dyspepsia (Rome3 criteria) who did not require immediate medication due to upper abdominal discomfort or persistent / recurrent pain Those who agree to the written consent of the applicant and who can cooperate with the necessary visits and related tests and surveys for the study process

Exclusion criteria

Exclusion criteria: 1. Subjects who are allergic to natural products and drug ingredients 2. Endoscopic examination of stomach: LA-A reflux esophagitis, gastric ulcer diagnosis, acute gastritis requiring treatment 3. Subjects who have had past gastric acid suppression surgery or stomach and esophagus surgery, except for closure of the ulcer or oversewing surgery 4. Subjects who need to take a steroids, bestero-inflammatory drugs, aspirin, or other drugs that can cause ulcers every day (but low-dose aspirin for cardiovascular disease) 5. Subjects diagnosed with malignant tumors within 5 years 6. Subjects who drink more than 4 times a week 7. Severe liver dysfunction (> 2.5 times normal upper limit of ALT, AST, r-GT) or serious liver dysfunction 8. Chronic kidney disease or severe renal disease including kidney dysfunction 9. Unregulated diabetes, cerebrovascular disease and Subject has been diagnosed within 3 months of the disease requiring surgery 10. Diagnosed within 3 months of the following diseases (Zollinger-Ellison syndrome, primary esophageal motility disorder, esophageal stricture, malignant disease of the gingival ulcer or upper gastrointestinal tract, pancreatitis, absorption disorder, severe cardiovascular disease or pulmonary disease) 11. Endoscopy within 2 weeks or before the first visit, subjects take gastrointestinal drugs such as PPI, H2 receptor antagonist, GERD treatment, or prokinetics 12. subjects continue to take the following drugs (diazepam, hydantoin derivative, warfarin, anticholinergic, prostaglandin analog, antineoplastic agent and more than 165 mg of salicylate, steroid, NSAISs, osteoporosis treatment) 13. Pregnant or nursing women 14. Subjects have participated in other clinical test within 4 weeks 15. Subjects who are judged to be unable to comply with the requirements of the test

Design outcomes

Primary

Measure	Time frame
Change of GSRS (Gastrointestinal Symptom Rating Scale) total	—

Secondary

Measure	Time frame
Change of GSRS (Gastrointestinal Symptom Rating Scale) 15 item	—

Countries

Korea, Republic of

Contacts

Public ContactKIM

Seoul National University Bundang Hospital

nakim@snubh.org+82-1588-3369

Outcome results