Health Condition 1: null- Chronic Kidney diseases
Conditions
Interventions
Intervention1: Nitrophage Forte: 45 days
Twice daily before 30 minutes of food for patients who are on Dialysis Trice daily before 30 minutes of food for predialysis patients
Control Intervention1: N
Sponsors
Mylin Biotech India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient aged >=18 to 65 years of both female and male to be included 2.CKD patients with GFR 3.HD patients GFR 4.Stage 3 and Stage 4 & 5 CKD patients 5.Patients who are on Dialysis for at least 3 months from the day of screening and Patients who are not doing well on Dialysis 6.Patient with the ability to provide written informed consent form 7.Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to any of the components of the formulation 2. Patient with history of treatment with NitroPhage Forte 3. Active infectious conditions within the last 30days. 4. New York Heart Association (NYHA) Classification Category III and IV Cardiac Insufficiency, Ischaemic Heart Disease, Coronary Insufficiency or any other clinically significant cardiovascular disease. 5. Patients who have participated in any clinical trial in the past 1 month. 6. Autoimmune disease e.g. SLE/Vasculities 7. Diabetic foot infection patients 8. Pregnant or lactating women. 9. Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Quality of life with improvement in nutritional status â?¢ Improvement in Anti inflammatory markers such as TNF α and IL6 Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Improvement in Lab Values such as BUN,Creatinine. â?¢ Improvement in Uraemic Pruritus Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactPrabhakaranP
Mylin Biotech
Outcome results
None listed