Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Ayurvedic and Unani Tibbia college and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of any gender aged 21 to 65 years diagnosed with Type 2 DM. 2. Fasting Blood sugar 126-179 mg/dl. 3. Post Prandial Blood Sugar 200 -249 mg/dl 4. Glycosylated Hemoglobin (HbA1c) 6.5- 7.9% 5. Subjects willing to provide written informed consent and able to come for follow up on scheduled visits.
Exclusion criteria
Exclusion criteria: 1. Individuals diagnosed with type 1 DM. 2. Subjects not taking any oral hypoglycemic drugs or insulin therapy. 3. Subjects suffering from the acute and chronic complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, diabetes ketoacidosis, hyperglycemic coma, peripheral artery disease, etc. which require emergency management. 4. Subjects with history of any cardiovascular disease such as coronary artery disease, congestive heart failure, Hypertension, valvular heart disease, etc. 5. Subjects with comorbidities such as Bronchial Asthma, COPD, Cerebrovascular Accident, tuberculosis, hypothyroidism, etc. 6. Subjects having immunocompromised state such as HIV or taking any immunosuppressive medications. 7. Subjects with history or active malignancy. 8. Subjects suffering from any major systemic illness necessitating long term treatment like rheumatoid arthritis, psychiatric disorders, and endocrinal disorders. 9. Subjects on corticosteroids, beta agonist, estrogen, progestins, antidepressants, antipsychotics etc. that may affect glucose metabolism. 10. Subject suffering from any hepatic disorder (SGPT and SGOT more than two times the upper limit of normal) 11. Subjects suffering from chronic kidney disease or any renal disorder (serum creatinine greater than 1.2 mg/dL). 12. Subjects having BMI greater than or equal to 32 kg/m2 13. Pregnant and lactating women. 14. Subjects taking medicines from any other traditional medicine systems for Type 2 DM. 15. Subjects with a history of smoking, alcohol intake or any substance abuse. 16. Subjects having hypersensitivity to any of the trial interventions or their ingredients. 17. Subjects who have completed participation in other clinical trials during the past 6 months. 18. Any other clinical condition that may compromise the safety of the individual in case of his or her participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting blood sugar and postprandial blood sugar from baseline.Timepoint: At Baseline, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1C from baseline.Timepoint: At Baseline, Day 90;Change in Fasting serum insulin and HOMA-IR from baseline.Timepoint: At Baseline, Day 90;Change in grading of symptoms of Madhumeha assessed through Developing guidelines for clinical research methodology in Ayurveda Timepoint: At Baseline, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90;Change in health related quality of life assessed through SF-12 questionnaire.Timepoint: At Baseline, Day 90;Incidence of adverse events.Timepoint: Day 15, Day 30, Day 45, Day 60, Day 75, Day 90;Change in the laboratory safety parameters (CBC, LFT, KFT, Lipid profile, Urine R& and M) from baseline.Timepoint: At Screening, Day 90 | — |
Countries
India
Contacts
Public ContactDR UMESH PATIL
Ayurvedic and Unani Tibbia College and Hospital
Outcome results
None listed