UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005878
Receipt number R000006941
Scientific Title Clinico-pathological study on the effectiveness of cepharanthin on the prevention of destruction of acinar structure in Sjogren's syndrome patients
Date of disclosure of the study information 2011/07/31
Last modified on 2011/06/29 16:00:34

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clinico-pathological study on the effectiveness of cepharanthin on the prevention of destruction of acinar structure in Sjogren's syndrome patients

Acronym

Effectiveness of cepharanthin on the acinar structure

Scientific Title

Clinico-pathological study on the effectiveness of cepharanthin on the prevention of destruction of acinar structure in Sjogren's syndrome patients

Scientific Title:Acronym

Effectiveness of cepharanthin on the acinar structure

Region

Japan


Condition

Condition

Sjogren's syndrome

Classification by specialty

Clinical immunology Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study the effectiveness of cepharanthin on the prevention of destruction of acinar structure

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement of infiltration of lymphocytes, Improvement of destruction of acinar structure

Key secondary outcomes

Increase in salivary flow, Improvement of CRP level


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

cepharanthin

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Primary Sjogren's syndrome

Key exclusion criteria

Secondary Sjogren's syndrome, Xerostomia due to aging

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Azuma

Organization

Institute of Health Biosciences, The University of Tokushima Graduate Faculty of Dentistry

Division name

Department of Oral Medicine

Zip code


Address

Kuramoto-cyo 3-18-15, Tokushima

TEL

088-633-7351

Email



Public contact

Name of contact person

1st name
Middle name
Last name Keiko Aota

Organization

Tokushima University Hoapital

Division name

Department of Oral Medicine

Zip code


Address

Kuramoto-cyo 3-18-15

TEL

088-633-7352

Homepage URL


Email



Sponsor or person

Institute

Department of Oral Medicine, Institute of Health Biosciences, The University of Tokushima Graduate Faculty of Dentistry

Institute

Department

Personal name



Funding Source

Organization

non

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

non


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

徳島大学病院(徳島県)


Other administrative information

Date of disclosure of the study information

2011 Year 07 Month 31 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

2011 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2012 Year 12 Month 01 Day

Date of closure to data entry

2012 Year 12 Month 01 Day

Date trial data considered complete

2013 Year 03 Month 01 Day

Date analysis concluded

2013 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 06 Month 29 Day

Last modified on

2011 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name