Efficacy and Safety of Nitrophage Forte in Predialysis and Dialysis Patients

Not Applicable

• Conditions: Health Condition 1: null- Chronic Kidney diseases

• Registration Number: CTRI/2015/09/006181
• Lead Sponsor: Mylin Biotech India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

1.Patient aged >=18 to 65 years of both female and male to be included

2.CKD patients with GFR <30 ml/minute

3.HD patients GFR <15ml/minute

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
�Quality of life with improvement in nutritional status <br/ ><br>�Improvement in Anti inflammatory markers such as TNF α and IL6 <br/ ><br>Timepoint: 6 weeks

Secondary Outcome Measures

Name	Time	Method
â?¢Improvement in Lab Values such as BUN,Creatinine. <br/ ><br>â?¢ Improvement in Uraemic Pruritus <br/ ><br>Timepoint: 6 weeks