UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051156 |
|---|---|
| Receipt number | R000058344 |
| Scientific Title | Evaluation of the usefulness of Unkeito together with Boiogito for arthralgia in menopausal patients. |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/05/24 15:40:12 |
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Basic information
Public title
Evaluation of the usefulness of Unkeito together with Boiogito for arthralgia in menopausal patients.
Acronym
Evaluation of the usefulness of Unkeito together with Boiogito for arthralgia in menopausal patients.
Scientific Title
Evaluation of the usefulness of Unkeito together with Boiogito for arthralgia in menopausal patients.
Scientific Title:Acronym
Evaluation of the usefulness of Unkeito together with Boiogito for arthralgia in menopausal patients.
Region
| Japan |
Condition
Condition
menopausal arthralgia
Classification by specialty
| Clinical immunology | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine whether the medical Kampo preparations Unkeito and Boiogito extract are useful when administered in combination for joint pain in menopausal disorders (menopausal arthralgia).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective intensity of the patient's arthralgia pain.
Key secondary outcomes
Adverse events caused by medication
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who attended the Department of Kampo Medicine, Tokai University Hospital, and the Kampo outpatient clinics of the Tomai Atsugi Clinic and Joetsu General Hospital between April 2020 and October 2022, and were treated for menopausal arthralgia with Unkeito extract and Boiogito extract in combination.
Key exclusion criteria
None
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nogami |
Organization
Tokai University
Division name
Department of Kampo Medicine
Zip code
2591193
Address
143 Shimokasuya, Isehara City, Kanagawa, Japan
TEL
+81-463-93-1121
t-nogami@tsc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuyna |
| Middle name | |
| Last name | Nogami |
Organization
Tokai University
Division name
Department of Kampo Medicine
Zip code
2591193
Address
143 Shimokasuya, Isehara City, Kanagawa, Japan
TEL
+81-463-93-1121
Homepage URL
t-nogami@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
NOGAMI tatsuya
Funding Source
Organization
None
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
The Tokai university Ethics Committee
Address
143 Shimokasuya, Isehara City, Kanagawa, Japan
Tel
0463-93-1121/ +81-463-93-1121
tokai-rec@tsc.u-tokai.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
| 2023 | Year | 06 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study.
Management information
Registered date
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058344
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
