Contusions, Myalgia, Pain, Sprains, Tendonitis
Conditions
Keywords
Plaster, injuries, regions miofasciais articulated, Reducing signs, symptoms
Brief summary
The purpose of this study is to evaluate the efficacy in reducing signs and symptoms in patients with contusions, sprains, muscular injuries and injuries with less than 24 hours early or holders of myalgia, pain and tendonitis in regions miofasciais articulated with Salonsip compared to Sabiá plaster. It is clinical, open, multicenter, randomized, prospective and comparative, with patients entering at random. Patients will be included in sufficient quantity to achieve the minimum number of 70 evaluable patients.
Interventions
DRUGSalonsip plaster
The plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).
DRUGSabia plaster
The plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).
Sponsors
Hisamitsu Farmaceutica do Brasil Ltda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes, of any race, aged 12 years; * Ability to read, understand and sign the Consent Form, in the case of children under age monitoring and consent of the person responsible; * Clinical diagnosis of bruises, sprains, trauma, muscle damage occurring in times less than 24 hours or myalgia, pain miofasciais or tendonitis. * Patients able to understand and maintain the clinical protocol
Exclusion criteria
* Known hypersensitivity to components of the formulas of both the product and the comparative test. * Known hypersensitivity to paracetamol. * Location of the lesion with skin wound or irritated. * Hepatic or renal diseases known. * Pregnant or breastfeeding. * Patients who require surgery or immobilization rigid; * Patients with fractures or rupture of the ligaments. * Patients in use of anticoagulants. * Patients with severe concomitant systemic diseases such as cancer, diabetes, congenital or acquired heart disease, hematological diseases, convulsive disorders, autoimmune diseases, renal failure, infections, hormonal disorders and pulmonary disorders. * History of alcoholism or use of illicit drugs; * Use of non-steroidal anti-inflammatory drugs, corticosteroids or venoterápicos, topics or any other form of administration. * Conditions which in the opinion of the investigator makes the patient unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Likert Scales and Visual Analogue Scales | two days |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation by adverse events relate. | two days |
Outcome results
None listed