Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Med Pharma CRO
Jamna Herbal Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 25 years or older, with Type 2 Diabetes Mellitus confirmed by WHO criteria for type 2 diabetes 2. Patients freshly diagnosed as diabetics or those who were on oral hypoglycemic agents without insulin 3. Patients willing to give written informed consent. 4. Patients are fit and no need for any hospital administration. 5. Patients willing to perform all study related procedures including the use of study medicine, allow the physical and Biochemical tests and willing to document symptoms and medication.
Exclusion criteria
Exclusion criteria: 1. Patients with renal impairment. 2. Patients will be also excluded if they have poorly controlled diabetes mellitus. 3. Female patients who are pregnant. 4. Unstable medical or psychiatric illness. 5. Chronic & acute disorders requiring hospital admission. 6. Known HIV-positive, Hepatitis B or C status. 7. Inability to carry out visits for the study. 8. Inability to maintain current medication regimen. 9. Inability or unwillingness to participate in all components of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment Questionnaire 2.Blood tests: FBG, PPBG, HbA1c (From Baseline to 90 days of treatment)Timepoint: 1.Assessment Questionnaire 2.Blood tests: FBG, PPBG, HbA1c (From Baseline to 90 days of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of Life 2. Drug safety: RFT & LFT 3. Incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period (From Baseline to 90 days of treatment)Timepoint: From Baseline to 90 days of treatment | — |
Countries
India
Contacts
Public ContactDr Parikshit Debnath
Med Pharma CRO
Outcome results
None listed