mucositis. Oral mucositis (ulcerative)
Conditions
Interventions
Intervention 1: Livergol 140 mg three tablets daily (produced Goldaro), oral, for 6 weeks. Intervention 2: placebo of livergol 140mg, three tablet daily, for 6 week, oral. Intervention 3: three milili
Treatment - Drugs
Placebo
Livergol 140 mg three tablets daily (produced Goldaro), oral, for 6 weeks
placebo of livergol 140mg, three tablet daily, for 6 week, oral
three mililiter of nano-silimarine syrup (140mg/cc), for 6 weeks, oral
placebo of nano-silimarine syrup, 3cc/day, for 6 weeks, oral
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria :age between 18 and 60, Patients treated with radiation therapy in head and neck; Radiation dose : 50-70 G; At least half of Oral cavity in the radiation exposure exclusion criteria:Liver failure(Because of the clearance of drugs) if ALT and AST level be more than two to three times higher than the upper limit normal at the beginning of treatment tgat patient will be excluded; Renal failure:GFR <50 ml / min; Severe infection requiring antibiotic therapy; Corticosteroids; pevious history of radiation therapy; patient unsatisfaction; A history of allergy to silymarin.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral Mucositis Assessment Scale. Timepoint: The first week after the intervention, after the intervention of the second week, third week after the intervention, after the intervention of the fourth week, the fifth week after the intervention, after six weeks of intervention. Method of measurement: interviews and Observation.;Visual analogue scale. Timepoint: The first week after the intervention, after the intervention of the second week, third week after the intervention, after the intervention of the fourth week, the fifth week after the intervention, after six weeks of intervention. Method of measurement: visual pain scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatic transaminase levels. Timepoint: Beginning of the study, the first week, second week, third week, four weeks, five weeks, six weeks. Method of measurement: laboratory.;Serum creatinine level. Timepoint: Beginning of the study, the first week, second week, third week, four weeks, five weeks, six weeks. Method of measurement: laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadreza Niazi moghadam
Mashhad University of Medical Sciences
Outcome results
None listed