drugset / Trial / NCT04198467

To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid

NCT04198467

Phase 2 Completed 100 enrolled Dr. Himanshu Bansal Foundation
RandomizedParallel-groupDouble-blindTreatment

Summary

Randomized, Double-blind, 12-month, placebo-controlled study was conducted on 100 outpatients . Intervention platelet rich plasma( PRP) prepared from 60 ml of blood by adding novel step of filtration to manual centrifuge step to achieve 7 times concentration. the efficacy was compared with administration of hyaluronic acid. Subjective Womac scores ,6 min pain free walking distance as well objective assessments MRI ,synovial fluid assessments were made out .Absolute counts of platelets as dose was evaluated to be effective in alleviating symptoms in early knee OA.

Timeline

Start
2014-10-21
Primary completion
2016-04-15
Completion
2016-07-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hyaluronic Acid Other / unclassified 4 ml Other
Subject Platelet Rich Plasma Other / unclassified 10 ml Other
Subject Platelet Rich Plasma Other / unclassified 1e+11 cells Other

Indications