UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014118
Receipt number 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 2022/09/29 08:33:57

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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

Obstetrics 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



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



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 or person

Institute

Kanazawa Medical University

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2013 Year 10 Month 18 Day

Date of IRB

2013 Year 11 Month 11 Day

Anticipated trial start date

2013 Year 12 Month 01 Day

Last follow-up date

2019 Year 03 Month 25 Day

Date of closure to data entry

2019 Year 03 Month 25 Day

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

2022 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016435


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name