Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: TLY-001 Kashayam: 15 ml TLY-001 Kashayam to be taken along with 45ml luke warm water, twice daily morning 7 AM and evening 6 PM oral administration in empty stomach for 90 days after
Sponsors
Clinfound Clinical Research Services PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with FBS >= 130 mg/dl to 2.Patients with BMI Ë? 45 kg/m2 . 3.Newly detected Type 2 Diabetes Mellitus (not more than 1 year). 4.The patient with the ability to understand and provide written informed consent form, which must have been obtained prior to screening. 5.Patients willing to comply with protocol requirements
Exclusion criteria
Exclusion criteria: 1.Patients with Type 1 Diabetes or secondary form of Diabetes 2.Pregnant, breast feeding, or planning a pregnancy. 3.Patient with history of treatment with Insulin 4.Patient with history of treatment with any antihyperglycaemic agent. 5.Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, GI tract, or central nervous system. 6.Known to have AIDS or HIV positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Sugar and Post Prandial Blood SugarTimepoint: Baseline,Day 30,Day 60,Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1CTimepoint: Baseline and Day 90;Lipid ProfileTimepoint: Baseline and Day 90;Liver Function TestTimepoint: Baseline and Day 90;Renal Function TestTimepoint: Baseline and Day 90 | — |
Countries
India
Contacts
Public ContactDr Sreejith Sreekumar
CARe-KERALAM Ltd
Outcome results
None listed