Health Condition 1: null- Diabetic Nephropathy
Conditions
Interventions
Intervention1: Renosante Tablet
: 1 Tablet Twice daily Oral for a period of three months
Control Intervention1: Placebo: 1 tablet Twice daily oral for a period of three months
Sponsors
The Himalaya Drug Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Both genders aged >=18 years and Subjects diagnosed with Type II diabetes mellitus >1year with controlled blood Sugar [Fasting blood sugar Subjects diagnosed with Diabetic nephropathy who have not had hemodialysis presenting with any one of the following clinical and/or lab parameters, Swelling of eyes/face, wrists, feet, ankles, foamy urine, Oliguria, Burning micturition, Nocturnal Urination, Turbid urine, Loss of Appetite and Mid back pain Serum Creatinine of >= ULN (up to 3mg/dl) Presence of Albuminuria. Glomerular Filtration Rate 30 - 60 mL/min/1.73m2 (Stage 2- Stage 3, mild to moderate) Blood Urea and Uric Acid >= Upper Limit of the Normal Subjects willing to sign informed consent and follow the study procedure. Has not participated in a similar investigation in past four weeks.
Exclusion criteria
Exclusion criteria: Subjects with the history of Alcoholism, Liver Failure (Acute or Chronic), Serum Creatinine of >= 3mg/dl, Overt Proteinuria, Uncontrolled Hypertension, Congestive Heart Failure, Benign prostatic hypertrophy, Malignancy, Bilateral Renal Artery Stenosis, History of Non Diabetic Renal Disease, Diabetic Ketoacidosis, Diabetic Complications etc. A known history or present condition of allergic response to any of the ingredients in the investigational product. Genetic and endocrinal disorders. Has participated in a similar clinical investigation in the past four weeks. Pregnant and lactating women. Subjects who refuse to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant Improvement in Renal function with normal limits of GFR and Serum CreatinineTimepoint: Screening End of first Month End of second Month End of Third Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved Renal function at different time points Improved Quality of Life with overall compliance to the interventionTimepoint: Screening End of third month (End of the study) | — |
Countries
India
Contacts
Public ContactDr Srikrishna H A
The Himalaya Drug Company Ltd
Outcome results
None listed