Xerostomia Sjogren's syndrome Xerostomia
Conditions
Interventions
Research subjects with Sjogren's syndrome who meet the registration requirements will be given an oral care product (gel) containing MA-T and asked to use it four times a day (morning, noon and night
MA-T containing oral care products (gel)
Sponsors
Takagi Yukinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who visited the xerostomia outpatient department of Nagasaki University Hospital, were aware of and complained of dry mouth, and were diagnosed with Sjogren'ssyndrome (meeting the diagnostic criteria ACR/EULAR:2016). 2. Patients who are 18 years of age or older at the time of obtaining consent 3. Patients who can visit the hospital during the research period (approximately 1 month) 4. Patients with salivary secretion of 2g/2min or less in the Saxon test conducted on the day consent was obtained 5. Patients who have received sufficient explanation to participate in this study, and who have given their own voluntary written consent based on sufficient understanding.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of hypersensitivity to the ingredients of this drug 2. Patients with a history of salivary gland irrigation treatment within the past year 3. Diabetic patients receiving drug treatment 4. Cancer patients undergoing treatment 5. Patients who are currently undergoing radiotherapy for cancer in the head and neck region or who have a history of radiotherapy 6. Patients who are undergoing chemotherapy or have a history of chemotherapy treatment for cancer 7. Patients undergoing renal disease treatment or renal dialysis 8. Patients undergoing treatment for mental illness (depression, autonomic imbalance, etc.) 9. Smoker at the time of informed consent 10. Patients who are pregnant at the time of obtaining consent 11. Other patients who are judged by the principal investigator or sub-investigator to be inappropriate as research subjects. 12. Patients participating in clinical trials or other clinical research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective symptoms (improved/non-improved) 2 and 4 weeks after starting use of the study drug It is considered an improvement if the VAS SCORE decreases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective findings, saliva volume (saliva during mastication), 2 weeks and 4 weeks after the start of study drug use, Intraoral moisture level, intraoral photo | — |
Contacts
Public ContactChiaki Shiraishi
Nagasaki University Hospital
Outcome results
None listed