Clinical trial: Efficacy and Safety of Salonsip Compared to Sabiá Plaster (NCT00970658)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.


Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? 0