Health Condition 1: R73- Elevated blood glucose level
Conditions
Interventions
Intervention1: Metaberine: Oral administration of single dose of Metaberine once a day for 14 days
Control Intervention1: Placebo: Oral administration of single dose of Placebo once a day for 14 days
Sponsors
ZeusHygia LifeSciences Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with fasting blood glucose levels between 100 mg per dL and 125 mg per dL 2.Subjects with post-prandial blood glucose level of 140 to 199 mg per dL 3.Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4.Subject willing and able to give informed consent and comply with the study procedures 5.Subjects who agrees to participate in this human application test and signs a written consent form before the test begins
Exclusion criteria
Exclusion criteria: 1.Subjects with a fasting blood sugar of greater or equal to 126 mg per dL, random blood sugar of greater or equal to 200 mg per dL, or patients with diabetes taking oral hypoglycemic agents or insulin 2.Subjects with glycated hemoglobin levels greater or equal to 6.5 percent 3.Subjects diagnosed with type 1 or type 2 diabetes 4.Subjects currently taking medications or dietary supplements related to diabetes 5.Subjects with clinically diagnosed chronic diseases 6.Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors 7.Subjects with uncontrolled high blood pressure 8.Subjects with a history of excessive alcohol consumption or substance abuse 9.Subjects with uncontrolled thyroid disorders 10.Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study period 11.Women of childbearing potential who are unable to use approved contraceptive methods 12.Subjects currently enrolled in another clinical trial or who have participated in a clinical trial within the past 30 days 13.Subjects with allergies to study-related interventions 14.Subjects with a history of significant adverse reactions to similar investigational products 15.Subjects who, in the judgment of the principal investigator, are unlikely to comply with study procedures or have conditions that could interfere with study completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of the investigational product intake on lowering postprandial blood glucose via an oral glucose tolerance test compared to placeboTimepoint: Day 0, Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of the investigational product on biomarkerTimepoint: Day 0, Day 14;To evaluate the effects of pharmacokinetic assessmentTimepoint: Day 0, Day 14;Overall SafetyTimepoint: Day 0, Day 14 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services
Outcome results
None listed