Health Condition 1: N00-N99- Diseases of the genitourinary system
Conditions
Interventions
Intervention1: Sirupeelai Kudineer: Sirupeelai Kudineer - 60ml twice a day for the period of one month
Control Intervention1: Not applicable:
No compararative agent in this study
Sponsors
Central Council for Research in Siddha
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent. 2. Subject is male or female, aged above 18yrs and below 70yrs 3. Subjects of Type 2 Diabetes with Hba1c levels 6.5 to 9% on monotherapy or combination of therapy with approved hypoglycaemic agents. 4. Subjects with residual albuminuria (ACR >3 mg/mmol) in the preceding 3 months - microalbuminuria (30-299 mg/g) daily. 5. Subject is willing and able to comply with all protocol requirements (with life style and diet regimen).
Exclusion criteria
Exclusion criteria: 1. Hypertensive subjects. 2. Subjects under Management for other Chronic or Neurological Illness 3. Subjects with Haemoglobin level less than 8 grams/dl. 4. Subjects with non diabetic renal diseases. 5. Subjects with multiple complications like Acidosis, hyperkalaemia, hypernatremia, Hyper hydrosis, Pericarditis, CCF, etc. 6. History of Infective, obstructive and reflux nephropathies. 7. Pregnancy and lactating females. 8. Subjects who have had treatment with an experimental (unlicensed) drug within 4 weeks. 9. Subjects undergoing treatment with immune-suppression agents. 10. Acute Renal failure (Sudden elevation in the level of S. Creatinine) and/or Subjects underwent Haemodialysis or Renal transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Reduction in Micro albuminuria. Increase in GFR. Secondary outcome: Delays the incidence of ESRD (dialysis, transplantation) Minimize hospitalization, Economic benefit to the subjects. Diminishes Cardiovascular morbidity. Reduces the risk of dialysis. Improvement in Quality of life (QOL) Timepoint: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Delays the incidence of ESRD (dialysis, transplantation) Minimize hospitalization, Economic benefit to the subjects. Diminishes Cardiovascular morbidity. Reduces the risk of dialysis. Improvement in Quality of life (QOL)Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactG S Lekha
Siddha Regional Research Institute
Outcome results
None listed