UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063300 |
|---|---|
| Receipt number | R000072459 |
| Scientific Title | The Effects of Regular Herbal Tea Consumption on Headaches |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/15 21:42:28 |
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Basic information
Public title
The Effects of Regular Herbal Tea Consumption on Headaches
Acronym
The Effects of Regular Herbal Tea Consumption on Headaches
Scientific Title
The Effects of Regular Herbal Tea Consumption on Headaches
Scientific Title:Acronym
The Effects of Regular Herbal Tea Consumption on Headaches
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of regular herbal tea consumption on headaches.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Headache Impact Test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Drinking herbal tea every night before bed
Interventions/Control_2
Drinking warm water every night before bed
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Non-smokers who report having headaches
Key exclusion criteria
Individuals with allergies to the herbs used (white willow, feverfew, lemon balm, hawthorn, rosehip) or to plants in the Asteraceae (daisy), Lamiaceae (mint), or Rosaceae (rose) families
Individuals who are pregnant, breastfeeding, or may be pregnant
Individuals currently receiving medical treatment for headaches
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Abe |
Organization
Tokyo University of Agriculture
Division name
Faculty of Agriculture, Department of Agricultural Innovation for Sstainable Society
Zip code
2430034
Address
1737 Funako, Atsugi-shi, Kanagawa-ken 243-0034 Japan
TEL
0462706616
ka207934@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Abe |
Organization
Tokyo University of Agricuture
Division name
Faculty of Agriculture, Department of Agricultural Innovation for Sstainable Society
Zip code
2430034
Address
1737 Funako, Atsugi-shi, Kanagawa-ken 243-0034 Japan
TEL
0462706616
Homepage URL
ka207934@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agricuture
Institute
Department
Personal name
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
Tokyo University of Agricuture
Address
1737 Funako, Atsugi-shi, Kanagawa-ken 243-0034 Japan
Tel
0462706616
ka207934@nodai.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
| 2026 | Year | 10 | Month | 15 | 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
| 2026 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072459
