A clinical study to evaluate the efficacy and safety of Proseventy in dialysis patients.
- Conditions
- Health Condition 1: null- Patients suffering from Chronic Kidney Disease and are on dialysis.
- Registration Number
- CTRI/2012/03/002516
- Lead Sponsor
- Panacea Biotec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
1 Patient willing to sign informed consent form.
2 Age of patient is 18 years or above.
3 Patients in the middle to high socioeconomic group.
4 Serum albumin < 3.8g/100ml
5 Patients on maintenance dialysis for atleast for 3 months.
6 Adequate dialyzed as per investigator
7 Absence of uremic symptoms
8 Patients classified as malnourished as per criteria listed in Annexure 1 (Diagnostic criteria for PEW as ISRNM)
1 Patients who do not have clinical PEW as per Annexure 1
2 Patients with systemic infection like TB or Malaria.
3 Patients who are currently using/ have discontinued use of any nutritional supplement
4 Plan for kidney transplantation within study period
5 Females who are pregnant or breast feeding
6 Life expectancy less than 6 month
7 Patient changed from haemodialysis to peritoneal dialysis
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To find out the efficacy of ProSeventy supplement on the nutritional status of the patients. <br/ ><br>To find out the safety of Proseventy supplement on the patient .Timepoint: At the end of the study (i.e. end of 6 months treatment period for a patient) <br/ ><br>
- Secondary Outcome Measures
Name Time Method To find out the factors that Impact on mortality and morbidity through biochemical parametersTimepoint: Till end of the study