Hafif- orta şiddette akut ayak bileği burkulması olan kişilerde etkinlik ve güvenliği değerlendirmek için %1 escin + %5 dietilamin salisilat kombinasyon jelinin randomize, düşük müdahaleli, çok merkezli, açık etiketli klinik çalışma.


Ülkar B.

Diğer Özel Kurumlarca Desteklenen Proje, 2023 - 2024

  • Proje Türü: Diğer Özel Kurumlarca Desteklenen Proje
  • Başlama Tarihi: Ekim 2023
  • Bitiş Tarihi: Mart 2024

Proje Özeti

Ankle ligament sprains are the single most common sports injury, accounting for 19–23% of all sports injuries presenting to accident and emergency departments. It has been estimated that an ankle injury occurs every day per 10,000 of the population. About 90% are inversion injuries affecting the lateral ligament complex.

Injuries to the soft tissue structures around the ankle are a major cause of short-term disability and pain due to inflammation; they often result in loss of function and can have long term consequences for returning to sport and work if not treated adequately. 

For topical treatment of soft tissue injuries like ankle sprain, a desirable approach should be to quickly relieve subjects’ pain while, at the same time, favoring reduction of swelling and recovery of the normal capillary network function. It should also be safe, well tolerated, easy to use, and accessible. Often all these requirements cannot be satisfactorily met by a single active principle. Therefore, combinations of substances with different modes of action are considered. Reparil Gel N formulation combines Diethylamine salicylate (DEAS), a NSAID with high rate of skin absorption, and Escin, the active component of Aesculus hippocastanum, the horse chestnut seed, which itself has been used as a traditional medicine for centuries, and is still used to treat certain conditions, including hemorrhoids, varicose veins, hematoma, and venous congestion. 

Treatment with Reparil Gel N combines the overall anti-inflammatory/ anti-edema effect of Escin with the topical analgesic/anti-inflammatory effect 

of DEAS with two different and synergistic mechanisms of actions. Reparil Gel N is an anti-swelling, anti-inflammatory treatment for short-term symptomatic treatment of acute blunt trauma which has shown efficacy especially when used at an early stage. 

Thus, the objective of this study is to evaluate the efficacy and safety of Reparil Gel N added to RICE protocol in a population affected by acute ankle sprain, applied within 12 hours (h) from injury in comparison to RICE protocol alone.