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A clinical study to evaluate the efficacy and safety of Proseventy in dialysis patients.

An open label randomized clinical study to evaluate the impact of Proseventy efficacy and safety in dialysis patients. - IMPROVES STUDY

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2012/03/002516
Enrollment
180
Registered
2012-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients suffering from Chronic Kidney Disease and are on dialysis.

Interventions

Intervention1: PROSEVENTY ProSeventy powder will be given orally as two scoops in a day (each scoop serving will have 15 g powder approx.).: Per 100g powder contains:- Source of protein is Soya Protei

Sponsors

Panacea Biotec Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To find out the efficacy of ProSeventy supplement on the nutritional status of the patients. 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)

Secondary

MeasureTime frame
To find out the factors that Impact on mortality and morbidity through biochemical parametersTimepoint: Till end of the study

Countries

India

Contacts

Public ContactMs Gitika
preetiwadhwa@panaceabiotec.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026