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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015574
Receipt No. R000018096
Scientific Title Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial
Date of disclosure of the study information 2014/11/05
Last modified on 2015/11/13

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Basic information
Public title Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial
Acronym Efficacy of acupuncture therapy on oversensitiveness to cold in females - randomized controlled trial
Scientific Title Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial
Scientific Title:Acronym Efficacy of acupuncture therapy on oversensitiveness to cold in females - randomized controlled trial
Region
Japan

Condition
Condition oversensitiveness to cold
Classification by specialty
Medicine in general Cardiology Psychosomatic Internal Medicine
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the efficacy of acupuncture therapy on oversensitiveness to cold in adult females by a multicenter prospective randomized controlled trial
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Variation of degree of hie on average visual analogue scale between before one week start of intervention and the second week start of intervention, after finish of intervention
Key secondary outcomes Changes in eight heading score and two component summary of SF-36v2 Standard Edition before and after the intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Needle retention to SP6 and electro-acupuncture therapy to BL32 at a frequency of 1Hz for 20min. for 4 sessions, with 1 session each other
Interventions/Control_2 No session(waiting list control)
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
18 years-old <=
Age-upper limit
39 years-old >=
Gender Female
Key inclusion criteria Adult females with oversensitiveness to cold and more than four point of total score in the" hiesho sensation scale"
Key exclusion criteria 1)pregnant or nursing
2)diabetes mellitus complicated by peripheral neuropathy
3)arteriosclerosis obliterans
4)Buerger's disease
5)connective tissue disease
6)hypothyroidism
7)hyperthyroidism
8)Patients medicated with following drugs every day: Chinese herbal medicine, alpha blocker, beta blocker, alpha and blocker, calcium antagonist and prostaglandinE1
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunji Sakaguchi
Organization Kansai University of Health Sciences
Division name Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code
Address 2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL 072-453-8409
Email sakaguti@kansai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunji Sakaguchi
Organization Kansai University of Health Sciences
Division name Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code
Address 2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL 072-453-8409
Homepage URL
Email sakaguti@kansai.ac.jp

Sponsor
Institute Kansai University of Health Sciences
Institute
Department

Funding Source
Organization Kansai University of Health Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Tsukuba University of Technology, Osaka Medical College, Takarazuka University of Medical and Health Care, Morinomiya University of Health Sciences, Riseisha College of Medicine and Sport
Name of secondary funder(s) Tsukuba University of Technology

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 関西医療大学(大阪府)、筑波技術大学(茨城県)、宝塚医療大学(兵庫県)、森ノ宮医療大学(大阪府)、履生社医療スポーツ専門学校(大阪府) Kansai University of Health Sciences(Osaka), Tsukuba University of Technology(Ibaragi), Takarazuka University of Medical and Health Care(Hyogo), Morinomiya University of Health Sciences(Osaka), Riseisha College of Medicine and Sport(Osaka)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 05 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 Completed
Date of protocol fixation
2014 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2014 Year 12 Month 27 Day
Date of closure to data entry
2015 Year 02 Month 20 Day
Date trial data considered complete
2015 Year 03 Month 20 Day
Date analysis concluded
2015 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 31 Day
Last modified on
2015 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018096

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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