UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005404 |
|---|---|
| Receipt number | 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 16:57:40 |
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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
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
Sponsor or person
Institute
Nihon University IItabashi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006414
