Patients with blunt impact injuries (traumatic injuries) MedDRA version: 9.1 Level: LLT Classification code 10044528 Term: Traumatic injury
Conditions
Interventions
Trade Name: Kneipp Arnika Salbe S
Pharmaceutical Form: Ointment
Other descriptive name: ARNICA FLOWER
Concentration type: range
Concentration number: 1:3,5-1:4,5
Trade Name: Ibutop Creme
Pharmaceutic
Sponsors
Kneipp-Werke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: blunt impact injury (not older than 1 hour), Age > 18 years, Force-induced pain reaction (meassured in N) on injured side must be above 150% of pain reaction on contralateral uninjured site, Informed consent acc. to § 40 AMG (German Drug Law) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Severe injury with e.g. massive swelling, rupture of ligament or fracture of the bone, Open wound; Any local or systemic drug treatment of the acute injury prior to enrolement, Systemic treatment with NSAIDs, anagesics or steroids 2 days prior to enrolement and during the study, Allergy or Hypersensitivity to any compenents of IMPs Pregnancy and/or Nursing Concurrent participation in another clinical trial Drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Influence of Arnika Salbe S compared to Ibutop Creme on induced pain reaction (Area under the curve of 6 hours treatment);Secondary Objective: Influence of Arnika Salbe S compared to Ibutop Creme on induced pain reaction (Area under the curve of 24 hours treatment) Influence of Arnika Salbe S compared to Ibutop Creme on passive movement pain Proportion of patients being symptom free at the end of treatment Time period to start sport activities again after start of treatment Global judgement of efficacy and safety by patient ;Primary end point(s): Area under the curve over 6 hours for quotient of force-induced pain reaction (pain reaction injured side / pain reaction contralateral unijured side) | — |
Countries
Germany
Outcome results
None listed