UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030863
Receipt number R000035236
Scientific Title A study to investigate the palliative benefit of Complex supplements for seasonal allergic conjunctivitis
Date of disclosure of the study information 2018/01/31
Last modified on 2018/07/19 14:28:28

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Basic information

Public title

A study to investigate the palliative benefit of Complex supplements for
seasonal allergic conjunctivitis

Acronym

A study to investigate the palliative benefit of Complex supplements for
seasonal allergic conjunctivitis

Scientific Title

A study to investigate the palliative benefit of Complex supplements for
seasonal allergic conjunctivitis

Scientific Title:Acronym

A study to investigate the palliative benefit of Complex supplements for
seasonal allergic conjunctivitis

Region

Japan


Condition

Condition

Seasonal allergic conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to assess the palliative benefit of Complex supplements for
seasonal allergic conjunctivitis by using QOL related questionnaire scores

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

QOL related questionnaire scores

Key secondary outcomes

Combination drug(anti-allergic medicine)The number of times of
usage - time of initiation of usage
QOL related questionnaire scores(interfere with everyday activities,condition)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of Complex supplements (Dosage (1)) component food (8 weeks)

Interventions/Control_2

Ingestion of Complex supplements (Dosage (2)) component food (8 weeks)

Interventions/Control_3

Ingestion of Complex supplements not containing component food (8 weeks)

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Subjects who is adults of both sexes above 20 years old
2) Subjects who competent to consent and give voluntary consent in writing with full understanding after reading briefing paper of this study aim and contents
3) Subjects with cedar pollen allergy
4) Subjects without any disease, lesion or malfunction on anterior segment of the eye

Key exclusion criteria

1) Subjects with systemic illness
that effects on health of the eye
2) Subjects who are in pregnancy, or lactation
3) Subjects who are receiving medical treatment except Artificial tears on local or entire body that affects the study
4) Subjects with Infectious eye disease
5) Subjects who have Systemic activity allergic disease (Asthma, Hives, Anaphylaxis etc)
6) Subjects with allergy to the food to be examined
7) Subjects who participate in other clinical trial currently, or participated in other clinical trial within 1 month prior to obtaining informed consent
8) Subjects who are under initial therapy for allergy to pollen
9) Subjects who are under treatment with medicinal product that is not anti-allergic medicine for this study, or subjects who are planning to use those medical drugs
10) Any candidates considered to be unsuitable for enrollment in the opinion of physician-in-charge

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yumiko Ide

Organization

Medical Corporation Chiseikai TOKYO CENTER CLINIC

Division name

Medical Corporation Chiseikai TOKYO CENTER CLINIC

Zip code


Address

1-1-8 Yaesu,Chuo-ku,Tokyo 103-0028,JAPAN

TEL

03-3276-6935

Email

tccide@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Shigeru Imai

Organization

CROee.INC

Division name

Evidence Division

Zip code


Address

2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan

TEL

03-5953-2108

Homepage URL


Email

imai@croee.com


Sponsor or person

Institute

CROee.INC

Institute

Department

Personal name



Funding Source

Organization

WAKAMOTO PHARMACEUTICAL CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

東京センタークリニック(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 01 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

Completed

Date of protocol fixation

2018 Year 01 Month 29 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2018 Year 04 Month 02 Day

Date of closure to data entry

2018 Year 04 Month 15 Day

Date trial data considered complete

2018 Year 04 Month 17 Day

Date analysis concluded

2018 Year 06 Month 29 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 17 Day

Last modified on

2018 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name