Health Condition 1: - Health Condition 2: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: TCa (Guduchi Ghan tablet prepared from fresh Guduchi): TCa tablet - 500 mg twice a day after breakfast and supper, orally with luke warm water, daily for a period of 3 months
Interventi
Sponsors
All India Institute of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Recently diagnosed (less than 1 year of diabetic history) cases of Type-2 DM and not taking any antidiabetic drug/Insulin since 2 months 2. Including both Pre-diabetes and diabetes cases Fasting Blood Sugar (FBS) ranges between 100 to 125 mg/dl in pre-diabetes and greater than 126 mg/dl to less than equal to 200 mg/dl in diabetes cases. Post Prandial Blood Sugar (PPBS) ranges between 140 to 199 mg/dl in Pre-diabetes and greater than 200 mg/dl to less than equal to 350 mg/dl in diabetes cases. HbA1c ranges between 5.7 % to 6.4 % in Pre-diabetes and greater than equal to 6.5 % to less than equal to 8 % in diabetes cases. 3. Presence of urine sugar 4. Frequency of urination 7 to 10 times per 24 hours and quantity and quantity greater than equal to 2500 ml 5. Accidentally diagnosed cases of Type-2 DM who visit the hospital for other complaints
Exclusion criteria
Exclusion criteria: 1. Cardiovascular disorder with Type-2 DM 2. Malignant and accelerated Hypertensive 3. Pregnant woman and planning to be pregnant within 6 months 4. Lactating mother 5. Secondary Diabetes Mellitus 6. Patients undergoing regular treatment for diabetes or any other severe illness 7. CNS Disorder e.g. Encephalopathy 8. Subjects already suffering from the complications of Diabetes (Diabetes Nephropathy, Diabetic retinopathy, Diabetic Neuropathy etc.) 9. Poorly controlled Glycemic status (HbA1c greater than 8%) 10. Concurrent serious hepatic dysfunction (AST or ALT greater than 3 times of upper normal limit) 11. Subjects on steroids, oral contraceptives or estrogen replacement therapy 12. Alcoholics and/or drug abusers 13. H/O hypersensitivity to any trial drug 14. Hypothyroidism or hyperthyroidism 15. Patients on vitamin B supplementation 16. Patients under other clinical trials for more than 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To access clinically the comparative anti-diabetic activity of Aardra (TCa) and Shushka (TCs) Guduchi by assessing the blood glucose level and HbA1c levelTimepoint: 1. Blood Glucose level - 0th day, 15 th day, 30th day, 45 th day, 60 th day, 75 th day, 90th day 2. HbA1c level - 0th day and 90th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Analytical study (HPLC, HPTLC) of TCa and TCs 2. Quality of Life assessment.Timepoint: HPLC and HPTLC - 0th Quality of Life - 0 and 90 th day | — |
Countries
India
Contacts
Public ContactDr Niranjan Ram
All India Institute of Ayurveda
Outcome results
None listed