Conditions: Sprain of Ankle
Keywords: ankle sprain traumeel diclofenac antiinflammatory time to normal function
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 449
Healthy volunteers: no

Brief summary:
The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.

Detailed description:
Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.

Arms:
arm 1: Traumeel S ointment 2 g, 3 times daily topical during 14 days arm 2: Traumeel S gel 2 g, 3 times daily topical during 14 days arm 3: Diclofenac gel 2 g, 3 times daily topical during 14 days

Interventions: intervention 1: Traumeel S ointment intervention 2: Traumeel S gel intervention 3: Diclofenac gel
Intervention descriptions: intervention 1: 2 g, 3 times daily topical during 14 days intervention 2: 2 g, 3 times daily topical during 14 days intervention 3: 2 g, 3 times daily topical during 14 days

Protocol document: