TRAUMEEL® PRODUCT MONOGRAPH30

6 CLINICAL STUDIES

Study design 449 physically active patients aged 18 40 years with unilateral sprain of the

lateral ligaments of the ankle joint (grades 1 and 2). Blinded* randomization to:

2 g Traumeel® ointment (n=152). 2 g Traumeel® gel (n=150). 2 g diclofenac 1% gel (n=147).

Treatment administered topically three times a day for 14 days. Follow-up was over 6 weeks.

End points Primary end points:

Ankle pain assessed by patients on a 0 100 mm Visual Analogue Scale (VAS) on day 7.

The Activities of Daily Living (ADL, 0 100) subscale of the Foot and Ankle Ability Measurement (FAAM)** on day 7.

Secondary end points measures at other time points 4,7, 14 and 42 included: Ankle pain assessed by patients on a 0 100 mm Visual Analogue Scale (VAS). The Activities of Daily Living (ADL, 0 100) subscale of the Foot and Ankle Ability

Measurement (FAAM). Swelling measured using the figure-of-eight method calculating the mean of

three repeated measurements. Global efficacy assessment, participant assessed on a 5-point rating scale (1 = very

good, 5 = worsening of symptoms) at day 14. Time to return to normal activity (training and sports) assessed on day 42.

* Double-blind (investigator and subject) for Traumeel® gel and diclofenac gel, and single-blind for Traumeel® ointment (investigator blinded; drug in preparation unknown to subject).

** The FAAM is a validated self-reported questionnaire [Martin 2005) that assesses physical function of individuals with musculoskeletal disorders of the leg, foot, and ankle. The FAAM ADL consists of 21 single items assessing activities of daily living such as standing, walking, and going up and down stairs

RANDOMIZED CONTROLLED CLINICAL TRIALS

Topical Traumeel® vs. diclofenac gel: Treatment of acute sprains of the ankle: TAASS

González de Vega C, Speed C, Wolfarth B, González J. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: A multicentre, randomized, blinded, controlled and non-inferiority trial. Int J Clin Pract. 2013;67(10): 979 989. Doi: 10.1111/ijcp.12219.

STUDY DESIGN FORMULATION INDICATION(S) Randomized, controlled, blinded study.

Traumeel® ointment and gel.

Unilateral sprain of the lateral ligaments of the ankle joint (grades 1 and 2).