TRAUMED - a Clinical Trial in Acute Ankle Sprain

NCT06192420 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 809

Last updated 2024-01-31

No results posted yet for this study

Summary

TRAUMED - a randomized clinical trial evaluating the efficacy and safety of Traumed® gel in patients with acute ankle sprain.

Conditions

  • Ankle Sprain

Interventions

DRUG

Traumeel®

3g of gel three times daily for 7days (+1 day visit window)

DRUG

Diclofenac sodium gel 1%

3g of gel three times daily for 7days (+1 day visit window)

DRUG

Placebo

3g of gel three times daily for 7days (+1 day visit window)

Sponsors & Collaborators

  • Biologische Heilmittel Heel GmbH

    lead INDUSTRY

Principal Investigators

  • Thomas Becker, Prof,PhD,MD · UKSH Universitätsklinikum Schleswig-Holstein, Campus Kiel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2020-11-18
Completion
2021-03-25

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT06192420 on ClinicalTrials.gov