UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055829 |
|---|---|
| Receipt number | R000063809 |
| Scientific Title | Physiological and psychological effects of treatments with herb balls |
| Date of disclosure of the study information | 2024/10/14 |
| Last modified on | 2024/10/14 22:06:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Physiological and psychological effects of treatments with herb balls
Acronym
Physiological and psychological effects of treatments with herb balls
Scientific Title
Physiological and psychological effects of treatments with herb balls
Scientific Title:Acronym
Physiological and psychological effects of treatments with herb balls
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the physiological and psychological effects of herb ball treatments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Heart rate variability (during treatment and at rest before and after treatment)
General affect scale (before and after treatment)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
30-minute Herb ball treatment performed
Interventions/Control_2
30-minute treatment with pseudo herb balls (stuffed with cloth instead of herbs)
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
| 30 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy people in their 30s and 40s
Key exclusion criteria
- Pregnancy or possible pregnancy
- Use of a pacemaker or other implantable electronic device
- Allergy to any of the plants used in the herb ball
- Diagnosis of any disorder
- Significant injury or pain in the neck, abdomen, or lower extremities where the treatment is to be performed
- Inability to perform the treatment Unable to consent to having their abdomen and other parts of their body undressed when having treatments directly on their skin (Treatment personnel are women).
Target sample size
30
Research contact person
Name of lead principal investigator
| 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
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
ABE Kenta
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
| 2024 | Year | 10 | Month | 14 | 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
30
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
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063809
