To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury. (LBB-ALI-01/09)

Laboratorio Brasileiro de Biologia

Status and phase

Unknown

Phase 3

Conditions

Muscle Injury

Tendinitis

Myalgia

Contusions

Trauma

Sprains

Myofascial Pain

Treatments

Drug: Aliviador

Drug: Gelol

Study type

Interventional

Funder types

Other

Identifiers

NCT01097798

LBB-ALI-01/09

Details and patient eligibility

About

Multicenter, randomized, double-blind trial, to evaluate the efficacy and safety Aliviador compared to Gelol in the relief of signs and symptoms in patients with contusions, sprains, trauma and muscle injury start with less than 24 hours or patients of myalgia, myofascial pain and tendinitis.

Enrollment

120 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of both sexes, of any race, aged over 12 years.
Ability to read, understand and sign the IC, in the case of minors consent of responsible;
Clinical diagnosis of bruises, sprains, trauma, muscle damage occurred in less than 24 hours or muscle pain, myofascial pain or tendinitis.
Patients able to understand and maintain the clinical protocol.

Exclusion criteria

Known hypersensitivity to components of the formulas of both the drug test as the comparator.
Known hypersensitivity to paracetamol.
Location of the lesion with skin wound or irritated.
Liver or kidney disease known.
Pregnant or lactating women.
Patients who require surgery or immobilization.
Patients with fractures or rupture of the ligaments.
Patients using anticoagulants.
Patients with severe concomitant systemic diseases, such as cancer, diabetes, or acquired heart disease, hematological diseases, seizure disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders.
History of alcoholism or illicit drug use;
Use of NSAIDs, corticosteroids or venoterápicos, topics or any other form of administration.
Conditions in the opinion of the researcher make the patient unsuitable to participate in the study.