UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049180 |
|---|---|
| Receipt number | R000055794 |
| Scientific Title | Comprehensive analysis of blood metabolites by muscle relaxation treatment 'Kanshoho'. |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2022/12/21 17:33:18 |
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Basic information
Public title
Comprehensive analysis of blood metabolites by muscle relaxation treatment 'Kanshoho'.
Acronym
Comprehensive analysis of blood metabolites by muscle relaxation treatment 'Kanshoho'.
Scientific Title
Comprehensive analysis of blood metabolites by muscle relaxation treatment 'Kanshoho'.
Scientific Title:Acronym
Comprehensive analysis of blood metabolites by muscle relaxation treatment 'Kanshoho'.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to conduct a comprehensive analysis of blood metabolites and to examine the usefulness of the treatment, in contrast to the no treatment group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1] Comprehensive analysis of blood metabolites. (1)
･Blood metabolome dual scan analysis(1)
[2] Effects
･Visual Analogue Scale(1)
(1): Before and 10, 30 minutes after treatment.[observation period I and II]
Key secondary outcomes
*Safety
[1] Blood pressure, pulsation.(1)
[2] Doctor's questions./Adverse events.(1)
[3] Subject's diary.(2)
*Other index
[1] Baseline characteristics (3)
[2] Height measurement (3)
[3] Weight, body fat percentage, BMI(4)
(1): Before and 30 minutes after treatment [Observation Period I, II.]
(2): Everyday from the starting day of Test Period I to the last day of the study.
(3): Observation Period I.
(4): Observation Period I, II.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
[1] Kanshoho (1 time/10 minutes).
[2] Observation.
[3] Washout (2weeks)
[4] Sham control (1 time/10 minutes).
[5] Observation.
Interventions/Control_2
[1] Sham control (1 time/10 minutes).
[2] Observation.
[3] Washout (2weeks)
[4] Kanshoho (1 time/10 minutes).
[5] Observation.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Japanese males and females aged 20-59 years
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3] Those with subjective symptoms of low back pain.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can come to the designated venue for this study and be inspected.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals using medical products.
[2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3] Individuals who used a drug to treat a disease in the past 1 month.
[4] Individuals who currently have skin inflammation, extensive rash, or edema
[5] Individuals who currently have a fracture or dislocation, or have a history of fracture or dislocation within the past year.
[6] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[7] Individuals who are a patient or have a history of or endocrine disease.
[8] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9] Individuals who experienced unpleasant feeling during blood drawing.
[10] Individuals whose BMI is less than 18.5kg/m2 and over 23.0kg/m2.
[11] Those who regularly receive treatments such as manipulative treatment, massage, acupuncture, and chiropractic, and those who have received these treatments within the past month.
[12] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[13] Individuals who work late night or shift work, or have irregular lifestyle habits. Also, individuals who may change their lifestyle during the examination period.
[14] Individuals who are pregnant, lactating, or may become pregnant.
[15] Individuals who participated in other clinical studies in the past 3 months.
[16] Individuals judged inappropriate for the study by the principal.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Health Organization
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 13 | 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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 10 | 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
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055794
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| Registered date | File name |
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