UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017933 |
|---|---|
| Receipt number | R000020789 |
| Scientific Title | Study of efficacy of Yokuinin in cervical dysplasia |
| Date of disclosure of the study information | 2015/06/17 |
| Last modified on | 2022/12/23 22:07:34 |
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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
| Obstetrics 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
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
fsk@p1.tst.ne.jp
Sponsor or person
Institute
Fushiki Clinic
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&languag
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&languag
Number of participants that the trial has enrolled
63
Results
38 cases were evaluated, and 27 cases became NILM. The time to NILM was as short as 4.8 months on average, and there was no difference between the high-risk type and the low-risk type.
Results date posted
| 2022 | Year | 12 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female 63 cases, CIN1 32 cases, CIN2 6 cases
Participant flow
Subject patients diagnosed at 3 facilities were asked to participate in this clinical study after explaining in accordance with the ethics committee.
Adverse events
2 cases of minor gastrointestinal symptoms
Outcome measures
1. Cervical cytology
2. HPV genotyping test
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
| 2022 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020789
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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