UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Estimation of efficacy of Reduced form of Coenzyme Q10 to seasonal allergy.
Title of the study (Brief title)	Efficacy of Reduced form of CoQ10 to seasonal allergy.
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effecacy of Reduced form of CoQ10 to several biological parameters induced by seasonal allergy-like symptom.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quality of life after 4 months intake.
Key secondary outcomes

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Reduced form of CoQ10, 100mg, 4 months
Interventions/Control_2	Reduced form of CoQ10, 150mg, 4 months
Interventions/Control_3	placebo, 4 months
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	Male and Female
Key inclusion criteria	1. age: over 20 y.o. under 65 y.o 2. sex: male and female 3. hospitalization or exogenous: exogenous 4. Possible to take test sample during test periods. 5. If under dietetics or kinesitherapy, continue it during test periods. 6. Have a subjective symptom such as cough, runny nose and sneeze in the period of seasonal allergy over 2 years.
Key exclusion criteria	1. Patients of seasonal allergy. 2. Using medicines such as anti-allergy and steroid. 3. Using Warfarin. 4. Have to use anti-allergy medicine during test periods. 5. Patients of nasal diseases such as nasal catarrh etc. 6. Doctor did not allowed to enrty to this study. 7. Patient of serious desease such as diabetes, liver disease, renal disease, heart disease, immunodeficiency, cancer, anemia, and asthma. Lactating, pregnant and wish to pregnant in this study periods. Use CoQ10 supplement. Entry another clinical study which ongoing or performed within 1 month.
Target sample size	60

Research contact person
Name of lead principal investigator	Kiyoshi Nakamura
Organization	HigashiKoganei Sakura clinic
Division name	Director of the Hospital
Address	4-37-26 Higashimachi, Koganei-city, Tokyo, 184-0011
TEL	042-382-3888
Email	kunitachissakura01@gmail.com

Public contact
Name of contact person	Satoshi Sakurai
Organization	imeQ Co. Ltd.
Division name	Pharmaceutical Division
Address	2-14-6 Nishi-Waseda, Sinjuku-ku, Tokyo, 169-0075
TEL	03-6205-6222
Homepage URL
Email	s-sakurai@imeq.co.jp

Sponsor
Institute	imeQ Co. Ltd.
Institute
Department

Funding Source
Organization	Kaneka Corporation
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

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 27 Day
Anticipated trial start date	2015 Year 12 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 22 Day
Last modified on	2017 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023117