Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Trucrose: Subjects will be administered with Trucrose 25 grams of powder orally once daily
Control Intervention1: Not Applicable: This is a single arm study hence comparator agent is No
Sponsors
Trulit Herbals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult, both male and female patients with Type 2 DM with fasting blood sugar between 120 and 200mg/dL 2.Those who are not avoiding oral intake of sugar 3.Be geographically accessible for follow up 4.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed
Exclusion criteria
Exclusion criteria: 1.Preganancy or child bearing ptetntial who are at risk of pregancy 2.Patients with recent stroke or heart attack 3.Fasting blood sugar >200mg/dL 4.Limited life expectancy 5.Patients with rasied Blood Urea and Cretainine or clinical suspicion of Diabetic Neuropathy 6.Recent minor/major surgeries 7.Alcoholic subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the HbA1C (%) from baseline to end of studyTimepoint: Baseline and End of the Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Serum insulin levels from baseline to end of the studyTimepoint: Baseline and End of the Study;Change in the lipid variables (TC, TG, LDL-C, HDL-C)Timepoint: Baseline and End of the Study;Changes in FPG and 2 hr PPG from baseline to end of the studyhTimepoint: Baseline, Week-2, week-4, week-8 and week-12 | — |
Countries
India
Contacts
Public ContactPrathap H D
Trulit Herbals
Outcome results
None listed