UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to investigate the palliative benefit of Complex supplements for seasonal allergic conjunctivitis
Title of the study (Brief title)	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	Yumiko Ide
Organization	Medical Corporation Chiseikai TOKYO CENTER CLINIC
Division name	Medical Corporation Chiseikai TOKYO CENTER CLINIC
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	Shigeru Imai
Organization	CROee.INC
Division name	Evidence Division
Address	2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL	03-5953-2108
Homepage URL
Email	imai@croee.com

Sponsor
Institute	CROee.INC
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035236