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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017933
Receipt No. R000020789
Scientific Title Study of efficacy of Yokuinin in cervical dysplasia
Date of disclosure of the study information 2015/06/17
Last modified on 2019/11/11

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Basic information
Public title Study of efficacy of Yokuinin in cervical dysplasia
Acronym Study of efficacy of Yokuinin in cervical dysplasia
Scientific Title Study of efficacy of Yokuinin in cervical dysplasia
Scientific Title:Acronym Study of efficacy of Yokuinin in cervical dysplasia
Region
Japan

Condition
Condition Patients diagnosed with cervical dysplasia(CIN1 or CIN2) in cervical cancer screening
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Consider the case invalid reexamination of the efeect of Yokuinin preparations for cervical dysplasia HPV types
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Cervical cytology
2.HPV-genotyping test
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Yokuinin
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 Cervical cancer screening was diagnosed with cervical dysplasia in meet the following condition.
1.Paients diagnosed with CIN1,CIN2 in cervical biopsy.
2.Patients who are not pregnant or breastfeeding.
3.Patients who will be able to obtain written informed consent.
Key exclusion criteria 1.Who has a serious diseases.
2.Patients who were judged to be inappropriate for the study by the investigator.
3.Those who have a history of cervical dysplasia or surgery by it.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Fushiki
Organization Fushiki clinic
Division name Director
Zip code 939-1352
Address 568, Miyamaru, Tonami City, Toyama
TEL 0763-32-2275
Email fsk@p1.tst.ne.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Fushiki
Organization Fushiki Clinic
Division name Director
Zip code 939-1352
Address 568,Miyamaru, Tonami City, Toyama
TEL 0763-32-2275
Homepage URL
Email fsk@p1.tst.ne.jp

Sponsor
Institute Fushiki Clinic
Institute
Department

Funding Source
Organization Kotaro Parmaceutical CO.,LTD.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1.Saiseikai Takaoka Hospital
2.Ladies'Clinic We!TOYAMA
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toyama Medical Association Ethics Review Committee
Address 336 Kamogawa,Toyama City, Toyama
Tel 076-429-4466
Email ishikai@toyama.med.or.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
2015 Year 06 Month 17 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
2015 Year 03 Month 31 Day
Date of IRB
2015 Year 02 Month 17 Day
Anticipated trial start date
2015 Year 06 Month 17 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 02 Month 26 Day

Other
Other related information

Management information
Registered date
2015 Year 06 Month 17 Day
Last modified on
2019 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020789

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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