Oral mucositis
Conditions
Interventions
Sasahealth 6.7mg gargled three times a day for 60 seconds before meals
Sponsors
Saitama Medical Center Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects are competent to consent, keep the rules of the study and are able to report self-condition. 2. Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study. 3. Subjects who are in hospital for oral and maxillofacial surgery of our hospital and developed oral mucositis.
Exclusion criteria
Exclusion criteria: 1. Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug poisoning, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) 2. Any history for drug allergy. 3. Subjects within three months after the participation to other clinical trials. 4. Subjects who are inadequate for enrollment judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The evaluation of oral mucositis after "Sasahealth" p.o. 2.The searching for inflammatory markers (IL-6, IL-8, etc.)in the saliva after "Sasahealth" p.o. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Safety assessment(adverse event) 2.Diary described 3.Questionnaire survey | — |
Countries
Japan
Contacts
Public ContactNorio HORIE
Saitama Medical Center Saitama Medical University Department of Oral and MaxillofacialSurgery
Outcome results
None listed