Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 30 to 60 years Sex either Newly diagnosed Patients having signs and symptoms of Prameha w.s.r to Type 2 Diabetes Mellitus Patients having F BSL-126 to 164 mg/dl PPBSL-140 to180 mg/dl and HbA1c 6.5% to 8% BMI in between 23-45 kg/m2 Patients having stable dose of metformin for whole trial period.
Exclusion criteria
Exclusion criteria: Known patient of Type 1 DM Patients on insulin or oral steroid treatment. Patients with other known systemic disorders Patient with known micro /macrovascular complications related to Diabetes such as CKD, Renal parenchymal Disease, Hepatic Dysfunction. Pregnant women and lactating Mothers. Patients unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To observe the changes in glycemic parametersTimepoint: 90 DAYS | — |
Secondary
| Measure | Time frame |
|---|---|
| To observe the changes in glycemic parametersTimepoint: 90 DAYS;To assess the effect of drug on sign and symptoms.Timepoint: 90 DAYS;To observe the changes in subjects Quality of Life by EQ5D QuestionnaireTimepoint: 90 DAYS;To assess effect on BMI and Waist circumferenceTimepoint: 90 DAYS;To assess the side effects if anyTimepoint: 90 DAYS | — |
Countries
India
Contacts
College of Ayureda Hospital Bharati Vidyapeeth Deemed To Be University