Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
Conditions
Interventions
Intervention1: Aavarai Kudineer: Decoction form
60 ml twice a day before food
Control Intervention1: No comparator: No comparator
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Adult men women transgender 40 years to 85 years of age Diabetic kidney disease DKD diagnosis of T2DM eGFR more than 45 mL/min/1.73 m2(20) ACR(spot microalbumin) more than 30 mg/g
Exclusion criteria
Exclusion criteria: Serum potassium more than 5.5 mmol per L 2. Haemoglobin A1c more than 10.5 percentage 3. Pregnancy breastfeeding or intention to become pregnant during the course of the study 4. Any other medical condition or clinically relevant abnormal findings in physical examination laboratory results or electrocardiogram (ECG) during screening that in the opinion of the investigator may compromise the safety of the subject in the study, reduce the subjects ability to participate in the study, or interfere with evaluation of the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is determined as the change in (reduction or non-progression) ACR from the baseline to the end of the treatment phase (week 24) Reduction or non-progression of SCr and improvement in eGFR at weeks 4 8 12 16 20 24 Level reduction in FBG and postprandial 2hour blood glucose 2h PG from baseline to week 12 at weeks 4 8 12 16 20 24 4. Change in Cystatin C(21) (reduction or non-progression) level will be measured and documented before initiation of treatment and at week 24. All the above will be considered as improvement. Timepoint: The primary outcome is determined as the change in (reduction or non-progression) ACR from the baseline to the end of the treatment phase (week 24) Reduction or non-progression of SCr and improvement in eGFR at weeks 4 8 12 16 20 24 Level reduction in FBG and postprandial 2hour blood glucose 2h PG from baseline to week 12 at weeks 4 8 12 16 20 24 4. Change in Cystatin C(21) (reduction or non-progression) level will be measured and documented before initiation of treatment and at week 24. All the above will be considered as improvement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction or non-progression of SCr and improvement in eGFR at weeks 4 8 12 16 20 24 Level reduction in FBG and postprandial 2hour blood glucose 2h PG from baseline to week 12 at weeks 4 8 12 16 20 24 4. Change in Cystatin C(21) (reduction or non-progression) level will be measured and documented before initiation of treatment and at week 24. All the above will be considered as improvement. Timepoint: baseline 24 weeks | — |
Countries
India
Contacts
Public ContactDrMRamamurthy
Department of Noi Naadal National Institute of Siddha
Outcome results
None listed