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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020309
Receipt No. R000023117
Scientific Title Estimation of efficacy of Reduced form of Coenzyme Q10 to seasonal allergy.
Date of disclosure of the study information 2015/12/24
Last modified on 2017/09/15

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Basic information
Public title Estimation of efficacy of Reduced form of Coenzyme Q10 to seasonal allergy.
Acronym Efficacy of Reduced form of CoQ10 to seasonal allergy.
Scientific Title Estimation of efficacy of Reduced form of Coenzyme Q10 to seasonal allergy.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kiyoshi Nakamura
Organization HigashiKoganei Sakura clinic
Division name Director of the Hospital
Zip code
Address 4-37-26 Higashimachi, Koganei-city, Tokyo, 184-0011
TEL 042-382-3888
Email kunitachissakura01@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Sakurai
Organization imeQ Co. Ltd.
Division name Pharmaceutical Division
Zip code
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)

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
2015 Year 12 Month 24 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
2015 Year 11 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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