UMIN-CTR Clinical Trial

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 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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040815