Clinical Trial to evaluate the efficacy of Sirupeelai kudineer in Diabetic Nephropathy
- Conditions
- Health Condition 1: N00-N99- Diseases of the genitourinary system
- Registration Number
- CTRI/2021/11/038210
- Lead Sponsor
- Central Council for Research in Siddha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: <br/ ><br>Reduction in Micro albuminuria. Increase in GFR. <br/ ><br>Secondary outcome: <br/ ><br> Delays the incidence of ESRD (dialysis, transplantation) <br/ ><br> Minimize hospitalization, Economic benefit to the subjects. <br/ ><br> Diminishes Cardiovascular morbidity. <br/ ><br> Reduces the risk of dialysis. <br/ ><br> Improvement in Quality of life (QOL) <br/ ><br>Timepoint: 1 month
- Secondary Outcome Measures
Name Time Method Delays the incidence of ESRD (dialysis, transplantation) <br/ ><br>Minimize hospitalization, Economic benefit to the subjects. <br/ ><br>Diminishes Cardiovascular morbidity. <br/ ><br>Reduces the risk of dialysis. Improvement in Quality of life (QOL)Timepoint: 6 months