UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035831 |
|---|---|
| Receipt number | R000040815 |
| Scientific Title | Analysis of the effects of treatment of alternative medicine and administration of medicine on the physiological value before treatment or administration |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2021/08/13 10:22:50 |
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Basic information
Public title
Analysis of the effects of treatment of alternative medicine and administration of medicine on the physiological value before treatment or administration
Acronym
Analysis of the effects of treatment of alternative medicine and administration of medicine on the physiological value before treatment or administration
Scientific Title
Analysis of the effects of treatment of alternative medicine and administration of medicine on the physiological value before treatment or administration
Scientific Title:Acronym
Analysis of the effects of treatment of alternative medicine and administration of medicine on the physiological value before treatment or administration
Region
| Japan | Asia(except Japan) |
Condition
Condition
Healthy and all diseases
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Ophthalmology | Dermatology |
| Psychiatry | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Anesthesiology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Aesthetic surgery | Laboratory medicine |
| Operative medicine | Emergency medicine | Blood transfusion |
| Intensive care medicine | Rehabilitation medicine | Dental medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To avoid in advance side effects, we want to show that our new therapeutic response analysis method and statistical analysis method are able to distinguish whether the therapeutic reactions are hypersensitivity reactions or conventional reactions or the reaction to maintain homeostasis without any new clinical trial but with using clinical data published in the academic or scientific journals and become public without any personal information.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It will be searched whether the therapeutic reactions are hypersensitivity reactions or conventional reactions or the reaction to maintain homeostasis and whether the reactions are statistically significant at time described in the literature.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 5 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Key inclusion criteria described in each literature
Key exclusion criteria
Key exclusion criteria described in each literature
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Torao |
| Middle name | |
| Last name | Ishida |
Organization
Suzuka University of Medical Science
Division name
Institute of TCM
Zip code
510-0293
Address
1001-1 Kishioka-cho, Suzuka-shi, Mie-ken, Japan
TEL
090-7695-8812
ishida-t@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Torao |
| Middle name | |
| Last name | Ishida |
Organization
Suzuka University of Medical Scence
Division name
Institute for TCM
Zip code
510-0293
Address
1001-1 Kishioka-cho, Suzuka-shi, Mie-ken, Japan
TEL
059-381-2385
Homepage URL
ishida-t@suzuka-u.ac.jp
Sponsor or person
Institute
Institute for TCM, Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of Medical Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee at Suzuka University of Medical Science
Address
3500-3, Minamitamagaki-cho, Suzuka City, Mie Prefecture
Tel
059-373-7811
isobe@suzuka-u.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
| 2019 | Year | 02 | Month | 12 | 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
| 2019 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will search literatures showing index values of individual subjects before and after treatment with alternative medicine such as acupuncture, finger pressure, massage, hyperthermia, meditation, qigong, Tai Chi, yoga, chiropractic, osteopathy, Kampo medicine, Chinese medicine, herbal, nutrition or administration of medicine whose effect differs from person to person with PubMed or PubMed Central (PMC). We will plot the relationship between the value before treatment with alternative medicine or administration of medicine and the increase or decrease value after the treatment or administration. From the plotting, we will determine whether the therapeutic responses are hypersensitivity reactions, or normal reactions, or reactions to maintain homeostasis. The usual reaction is analyzed by conventional statistical analysis and the hypersensitive reactions and homeostatic reactions are analyzes by the new statistical analysis method suitable for those reactions to check whether the reactions are statistically significant.
Management information
Registered date
| 2019 | Year | 02 | Month | 10 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040815
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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