A prospective ,Open Label,Observational Study to evaluate the Efficacy and Safety of Nitrophage Forte in Predialysis and Dialysis Patients

Mylin Biotech India Pvt Ltd0 个研究点目标入组 45 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

•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.

发起方

Mylin Biotech India Pvt Ltd