Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
LYBL Healthcare Technology India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Diabetic Participants (Groups A & B): Newly diagnosed type 2 diabetes mellitus Diagnosed within 3 months of time HbA1c more than 6.5% and less than 9% Prediabetic Participants (Group C): Known pre-diabetics for more than 1 year HbA1c between 5.7% and 6.5% No systemic comorbidities like cardiovascular disease, renal impairment, or hepatic dysfunction. No evidence of significant complications of diabetes (e.g., retinopathy, nephropathy, neuropathy)
Exclusion criteria
Exclusion criteria: Previously diagnosed Type 1 or Type 2 DM on insulin treatment Secondary diabetes due to other conditions (e.g., pregnancy, Cushing s syndrome, pancreatitis) Pregnant and lactating mother History of gestational diabetes Concurrent use of other Ayurvedic or herbal medications for diabetes during past 6 months Subjects who have completed participation in any other clinical trial during past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Fasting Blood Sugar (FBS) Postprandial Blood Sugar (PPBS) HbA1c (glycated hemoglobin) Serum insulin (fasting) Urine analysis (urine glucose/ketones) Timepoint: 0th day and 90th Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptom evaluation: fatigue, polyuria, polydipsia, polyphagia WHO Quality of Life assessment: subjective improvement in daily well-being and energy levels BMI (Body Mass Index) Safety Parameters: Liver Function Test (LFT) Renal Function Test (RFT) Hemogram for general systemic assessment Monitoring of Adverse Events (AEs) throughout the study Timepoint: 0th day, 30th day, 60th day and 90th day | — |
Countries
India
Contacts
Public ContactDr Keertan M S
KAHERs Shri B M Kanakanwadi Ayurveda Mahavidyalaya
Outcome results
None listed