Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Medi Hero Biotech LLP
Eligibility
Inclusion criteria
Inclusion criteria: Fasting plasma glucose 7-11 mM per L. HbA1C 7-9 percentage. Fasting insulin more than 25 U per ml. Newly diagnosed, drug-naive patients with type 2 diabetes. Capable of and freely willing to provide written informed consent prior to participating in the study.
Exclusion criteria
Exclusion criteria: Type 1 diabetes. Liver and kidney failure. Female participants under pregnancy or during breastfeeding period. Participants having hypersensitive predisposition or hypersensitive to test medicine. Pregnant woman, lactating woman, and woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception during the study. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood FBG, HbA1c, fasting serum Insulin, HOMA2-IR, HOMA2-B, Lipid profileTimepoint: Baseline, 4 weeks, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory safety parameters (FBS, CBC, LFT and kidney function tests). Occurrence of adverse events.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactMrs Supriti Choudhury
J. B. Roy State Ayurvedic Medical College and Hospital
Outcome results
None listed