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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035831
Receipt No. 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 2019/02/10

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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 Obsterics 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
Middle name
Last name Torao Ishida
Organization Suzuka University of Medical Science
Division name Institute of TCM
Zip code
Address 1001-1 Kishioka-cho, Suzuka-shi, Mie-ken, Japan
TEL 059-381-2385
Email ishida-t@suzuka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Torao Ishida
Organization Suzuka University of Medical Scence
Division name Institute for TCM
Zip code
Address 1001-1 Kishioka-cho, Suzuka-shi, Mie-ken, Japan
TEL 059-381-2385
Homepage URL
Email ishida-t@suzuka-u.ac.jp

Sponsor
Institute Institute for TCM, Suzuka University of Medical Science
Institute
Department

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
Address
Tel
Email

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
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
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040815

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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