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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014118
Receipt No. R000016435
Scientific Title Study of efficacy of Yokuinin in cervical intraepithelial neoplasma.
Date of disclosure of the study information 2014/05/30
Last modified on 2014/05/30

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

Condition
Condition Patients diagnosed with CIN1, CIN2, CIN3 in cervical cytology.
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We weigh efficacy of Yokuinin treatment with the historical data of phenol therapy of Yokuinin non-administration in cervical intraepithelial neoplasma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Cervical cytology
2. Examination liquefaction specimen cell (LBC)
3. HPV-genotyping test
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria Patients diagnosed with CIN1, CIN2, CIN3 in cervical cytology.
1. Patient who are not pregnant or breastfeeding.
2. Patients aged 20 years old and older and 65 years old and under.
3. Patient who is CIN-positive in HPV test of HC-II.
4. Patients who will be able to obtain written informed consent.
Key exclusion criteria 1. Patients who take the steroid and/or the immunosuppressant, or with severe disease.
2. Patients who were judged to be inappropriate for the study by the investigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Sasagawa
Organization Kanazawa Medical University
Division name Obstetrics and Gynecology
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Email tsasa@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Sasagawa
Organization Kanazawa Medical University
Division name Obstetrics and Gynecology
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Homepage URL
Email tsasa@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kanazawa Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 30 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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 12 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
2014 Year 05 Month 30 Day
Last modified on
2014 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016435


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