UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047900 |
|---|---|
| Receipt number | R000054387 |
| Scientific Title | Clinical trial for the effect of improving physical function by chiropractic care, or combination of chiropractic care and dietary supplement or physical therapy in healthy Japanese subjects: a parallel-group comparison study |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2024/12/04 08:59:39 |
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Basic information
Public title
Clinical trial for the effect of improving physical function by chiropractic care, or combination of chiropractic care and dietary supplement or physical therapy in healthy Japanese subjects: a parallel-group comparison study
Acronym
Clinical trial for the effect of improving physical function by chiropractic care, or combination of chiropractic care and dietary supplement or physical therapy in healthy Japanese subjects: a parallel-group comparison study
Scientific Title
Clinical trial for the effect of improving physical function by chiropractic care, or combination of chiropractic care and dietary supplement or physical therapy in healthy Japanese subjects: a parallel-group comparison study
Scientific Title:Acronym
Clinical trial for the effect of improving physical function by chiropractic care, or combination of chiropractic care and dietary supplement or physical therapy in healthy Japanese subjects
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of improving physical function through treatment such as chiropractic care
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Questionnaires and medical record
Key secondary outcomes
Blood test, moisture of the skin, and postural distortion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment | Maneuver |
Interventions/Control_1
Duration: Four weeks
Intervention: Nothing care
Interventions/Control_2
Duration: Four weeks
Intervention: Only chiropractic care
Interventions/Control_3
Duration: Four weeks
Intervention: Chiropractic care + taking dietary supplements (CALFAMILY / Muscle Mate / PYCNOMIN AG)
Administration: CALFAMILY (one packet), Muscle Mate (seven to fifteen tables), and PYCNOMIN AG (four to six tablets) with water once a day
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within
Interventions/Control_4
Duration: Four weeks
Intervention: Chiropractic care + improvement of sleep (using mattress (HEALTHWAVE))
*Sleep on a designated mattress
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged between 20 and 60
4. Healthy subjects
5. Subjects who have not undergone chiropractic care (for at least one year)
6. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, stroke disorder, dyslipidemia, hypertension, neoplastic disease, hemorrhagic disease, infectious disease, amyotrophy, heart disease, disc herniation, ossification of the posterior longitudinal ligament, spondylosis deformans, spinal stenosis, osteoporosis, atlantoaxial subluxation, unstable spine, scoliosis, spina bifida, spondylolisthesis, or any other chronic diseases
4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
5. Subjects who currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, lactation, or planning to become pregnant
8. Subjects who suffer from COVID-19
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are smokers
11. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Kobayashi |
Organization
Sakura General Hospital
Division name
Director
Zip code
480-0127
Address
1-129, Shingu, Oguchi-cho, Niwa-gun, Aichi, Japan
TEL
0587-95-6711
hisho@ijinkai.or.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Nakatsu |
Organization
Nihontyokuhan Souhonsya Co.,Ltd.
Division name
Corporate strategy division
Zip code
151-0051
Address
8F NEX Shinjuku Bldg., 5-34-7, Sendagaya, Shibuya-ku, Tokyo, Japan.
TEL
03-3356-0621
Homepage URL
nakatsu_hiromitsu@zenkenkai.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
national university corporation Tokushima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Nihontyokuhan Souhonsya Co.,Ltd.
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Sakura General Hospital
national university corporation Tokushima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
さくら総合病院 (愛知県)
Sakura General Hospital (Aichi, Japan)
国立大学法人徳島大学 (徳島県)
national university corporation Tokushima University (Tokushima, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | 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
48
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 | 04 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | 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 | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054387
