A clinical study to check the efficacy and safety of investigational Product in indigestio
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Registration Number
- CTRI/2020/04/024448
- Lead Sponsor
- SD Biotechnologies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1.Adult male and female over 19 to 60 years old
2.Patients diagnosed with functional dyspepsia (Rome IV criteria) who did not require immediate medication due to upper abdominal discomfort or persistent/recurrent pain
3.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.
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 oesophagus surgery, except for closure of the ulcer or over sewing 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 ( >2 times normal upper limit of Creatinine at screening visit)
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 oesophageal motility disorder oesophageal 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, nursing women or those who have a plan to become pregnant within 3 months.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinically significant positive change from baseline to EOT (End of treatment) in the following efficacy parameters: <br/ ><br>1.GSRS (Gastrointestinal symptom rating scale) <br/ ><br>2.SF36 Questionnaire <br/ ><br>Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method 1.SOD (Superoxide dismutase) <br/ ><br>2.MDA(Malondialdehyde) <br/ ><br>3.mucin1 <br/ ><br>Timepoint: 12 weeks