UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020309 |
|---|---|
| Receipt number | 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 15:36:29 |
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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
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
s-sakurai@imeq.co.jp
Sponsor or person
Institute
imeQ Co. Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023117
