UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046014 |
|---|---|
| Receipt number | R000052525 |
| Scientific Title | Examination of the effect of hainosankyuto on chronic osteomyelitis of the jaw |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2023/03/14 11:53:58 |
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Basic information
Public title
Examination of the effect of hainosankyuto on chronic osteomyelitis of the jaw
Acronym
The effect of hainosankyuto on chronic osteomyelitis
Scientific Title
Examination of the effect of hainosankyuto on chronic osteomyelitis of the jaw
Scientific Title:Acronym
The effect of hainosankyuto on chronic osteomyelitis
Region
| Japan |
Condition
Condition
chronic osteomyelitis of the jaw
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are many cases of chronic osteomyelitis of the jaw in which pain is difficult to control. We have had good results using hainosankyuto for patients who visited our department with intractable chronic osteomyelitis. In this study, we will investigate the clinical efficacy of hainosankyuto in chronic osteomyelitis of the jaw in comparison with the general treatment group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the rate of change of VAS (Visual Analogue Scale) at the end of administration between groups
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hainosankyuto(2.5g) 3 times a day before each meal for 1 month.
Interventions/Control_2
Western drugs such as NSAIDs, acetaminophen, and azulene containing gargle for 1 month.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with chronic osteomyelitis (sclerosing osteomyelitis, chronic pyogenic osteomyelitis, SAPHO syndrome, ARONJ, etc.) at the Department of Oral Surgery, Tokyo Medical and Dental University Hospital.
Key exclusion criteria
(1) Patients with hepatic or renal dysfunction.
(2) Patients who are allergic to any kind of drugs.
(3) Patients who have received some kind of Kampo medicine treatment within 4 weeks.
(4) Patients who have acute symptoms and oral surgical treatment is the first priority.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Yamazaki |
Organization
Tokyo Medical and Dental University Hospital
Division name
Orofacial Pain Clinic
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-5762
yamazaki-yo.ofpm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Yamazaki |
Organization
Tokyo Medical and Dental University Hospital
Division name
Orofacial Pain Clinic
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-4563
Homepage URL
yamazaki-yo.ofpm@tmd.ac.jp
Sponsor or person
Institute
Department of Orofacial Pain Clinic, Tokyo Medical and Dental University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Dental Anesthesiology and Orofacial Pain Management, Division of Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dental Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ku Tokyo
Tel
03-5803-5404
d-hyoka.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052525
