UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015574 |
|---|---|
| Receipt number | 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 16:34:23 |
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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 |
| Obstetrics 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
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
sakaguti@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018096
