None listed
Conditions
Interventions
Intervention1: MEBO (Moist Expose Burn Ointment): Made up of 5 components (Radix Scutellariae 4.50%, Rhizoma Coptidis 4.50%, Cortex Phellodendri 4.50%, Pheritima 1.80%, Pericarpium Papaveris 1.80%, Ol
Sponsors
Shantou MEBO Pharmaceutical Co, Ltd.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Mild thermal origin burns (Superficial II Degree burns and total burn area for all burns on a single patient no greater than 15% of TBSA); 2. Male or female between 13 and 50 years of age; 3. Patient or patient?s legally acceptable representative is willing to provide voluntary informed consent; 4. Capable of understanding and willing to comply with study protocol requirements; 5. Agree to stay in hospital for the first 7 days of treatment; 6. Female of childbearing potential with a negative result from pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial; and 7. Subjects infected with MRSA can be included based on the opinion of the Investigator.
Exclusion criteria
Exclusion criteria: 1. Subjects with chemical, electrical, and radiation burns; 2. Pregnant or breast-feeding female; 3. Known or suspected allergies to any of the components of MEBO; 4. Subjects who in the opinion of the Investigator are not suitable for inclusion; 5. Subjects previously on any other topical treatment except SSD; 6. Any immune deficiency disorder, or known clinically significant organ or systemic diseases, such that, in the opinion of the investigator, the significance of the disease will compromise the subject?s participation in the study (e.g., severe retinopathy requiring laser therapy, terminal kidney disease etc.); or 7. Participation in another investigational drug study within 30 days prior to treatment start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of MEBO in comparison with SSD in the patients with mild thermal burn injuries, through the clinical laboratory report, physical examination, the invasive infection rate.Timepoint: 14 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of MEBO in comparision with SSD in the patients with mild thermal burn injuries, through the assessment of analgesic effect, the wound healing time (days), the wound healing rate in 10 days and the wound healing qualityTimepoint: 10 Days | — |
Countries
India
Contacts
Public ContactDr. A. Sivakumar
Outcome results
None listed