UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050697 |
|---|---|
| Receipt number | R000057683 |
| Scientific Title | Confirmation of the efficacy and safety of Goreisan for headache associated with weather changes-Retrospective observational study- |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/08/30 14:12:30 |
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Basic information
Public title
Confirmation of the efficacy and safety of Goreisan for headache associated with weather changes-Retrospective observational study-
Acronym
Confirmation of the efficacy and safety of Goreisan for headache associated with weather changes-Retrospective observational study-
Scientific Title
Confirmation of the efficacy and safety of Goreisan for headache associated with weather changes-Retrospective observational study-
Scientific Title:Acronym
Confirmation of the efficacy and safety of Goreisan for headache associated with weather changes-Retrospective observational study-
Region
| Japan |
Condition
Condition
meteoropathy with headache
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of TJ-17 Tsumura Goreisan extract granules (medical use) (hereinafter referred to as TJ-17) for headache associated with weather changes (atmospheric pressure, temperature difference, humidity).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in number and severity of headaches per week
Key secondary outcomes
Change in number of analgesics taken per week
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients judged by a doctor to have weather disease with headache
(2)Patients who received TJ-17
Key exclusion criteria
(1)Patients who have not visited the hospital since the first visit
(2)Patients with <1/3 adherence to TJ-17 during the data collection period
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Kudeken |
Organization
Internal medicine+neurology
Division name
Internal medicine
Zip code
158-0094
Address
3-39-12,Tamagawa,Setagaya-ku,Tokyo
TEL
03-6805-6418
neben1100306@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Kudeken |
Organization
Internal medicine+neurology
Division name
Internal medicine+neurology
Zip code
158-0094
Address
3-39-12,Tamagawa,Setagaya-ku,Tokyo
TEL
03-6805-6418
Homepage URL
neben1100306@yahoo.co.jp
Sponsor or person
Institute
internal medicine + neurology
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yoyogi Mental Clinic Research Ethics Committee
Address
3F,4-26-11,Sendagaya,Shibuya-ku,Tokyo
Tel
03-6804-2227
cns_jimu@triad-j.co.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
せたがや内科・神経内科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 31 | 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
100
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research period:Ethics review board approval date-30/9/2023
Duration of study subjects:12/2021-12/2022
Survey data collection period:12/2021-12/2023
Management information
Registered date
| 2023 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057683
