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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005404
Receipt No. R000006414
Scientific Title Effect of Kampo for uncomfortable cold feeling of female and evaluation of clinical examinations
Date of disclosure of the study information 2011/04/10
Last modified on 2011/04/14

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Basic information
Public title Effect of Kampo for uncomfortable cold feeling of female and evaluation of clinical examinations
Acronym Effect of Kampo for cold feeling and evaluation of examinations
Scientific Title Effect of Kampo for uncomfortable cold feeling of female and evaluation of clinical examinations
Scientific Title:Acronym Effect of Kampo for cold feeling and evaluation of examinations
Region
Japan

Condition
Condition uncomfortable cold feeling
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study evaluation of clinical examinations in improvement of uncomfortable cold feeling case with Kampo
Basic objectives2 Others
Basic objectives -Others To investigate of improvement effect with Kampo for uncomfortable cold feeling in femal
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of clinical examinations
Key secondary outcomes Improvement effect for uncomfortable cold feeling with Kampo

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Kampo medicine
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria Female, over 20 years old
Patients with uncomfortable cold feeling
Out hospital patients
Indication of Toki-shakuyaku-San, Kami-Shoyo-San,or Keishi-bukuryo-Gan,
Record of Informed concent
Key exclusion criteria intorelance of lactose.
received Kampo within 2 weeks
Disorder of liver. kidney, thyroid,or electrolytes
Not proper for the study evaluated by the investigators
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YAKUBO, Shuji
Organization Nihon University IItabashi Hospital
Division name Department of Oriental medicine
Zip code
Address 30-1 Oyaguci-Kamicyo, Itabashi-Ku
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yakubo, Shuji
Organization Nihon University IItabashi Hospital
Division name Department of Oriental medicine
Zip code
Address 30-1 Oyaguci-Kamicyo, Itabashi-Ku
TEL 03-3972-8111
Homepage URL
Email

Sponsor
Institute Nihon University IItabashi Hospital
Institute
Department

Funding Source
Organization AKAEDA MEDICAL RESEARCH FOUNDATION
Organization
Division
Category of Funding Organization Non profit foundation
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 日本大学板橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 10 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
2011 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 08 Day
Last modified on
2011 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006414

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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