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Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction

NCT03355651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-11-30

No results posted yet for this study

Summary

This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the standard rehabilitation protocol only after arthroscopically-assisted functional ACL reconstruction with hamstrings.

Conditions

  • ACL Reconstruction

Interventions

DIETARY_SUPPLEMENT

PROGEN

Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-09
Primary Completion
2017-02-01
Completion
2017-03-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355651 on ClinicalTrials.gov