UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033639
Receipt number R000038230
Scientific Title Effect of co-administration of quercetin on the endothelial dysfunction after continuous treatment of nitroglycerin in Japanese volunteers with aldehyde dehydrogenase2 *2 polymorphism: randomized crossover trial
Date of disclosure of the study information 2018/08/06
Last modified on 2019/02/04 10:14:11

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Basic information

Public title

Effect of co-administration of quercetin on the endothelial dysfunction after continuous treatment of nitroglycerin in Japanese volunteers with aldehyde dehydrogenase2 *2 polymorphism: randomized crossover trial

Acronym

Effect of quercetin on the endothelial dysfunction after nitroglycerine treatment in Japanese volunteers with ALDH2 *2 polymorphism

Scientific Title

Effect of co-administration of quercetin on the endothelial dysfunction after continuous treatment of nitroglycerin in Japanese volunteers with aldehyde dehydrogenase2 *2 polymorphism: randomized crossover trial

Scientific Title:Acronym

Effect of quercetin on the endothelial dysfunction after nitroglycerine treatment in Japanese volunteers with ALDH2 *2 polymorphism

Region

Japan


Condition

Condition

angina pectoris

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To determine the effect of co-administration of quercetin, which has antioxidant effect, on the endothelial function after continuous treatment of nitroglycerin in Japanese healthy volunteers with aldehyde dehydrogenase2 (ALDH2) *2 polymorphism

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relation between ALDH2 polymorphisms and the values of flow-mediated dilation, and oxidative stress (malondialdehyde).

Key secondary outcomes

Relation between ALDH2 polymorphisms and blood pressure, pulse rate.
Relation between ALDH2 polymorphisms and the rate of adverse events.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

nitroglycerin 25 mg/day is transdermally administered for 7 days

Interventions/Control_2

nitroglycerin 25 mg/day and quercetin 1000mg/day are administered for 7 days

Interventions/Control_3


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

45 years-old >

Gender

Male and Female

Key inclusion criteria

Japanese healthy volunteers who are older than 20 and younger than 45
Volunteers who have ALDH2 *1/*1 or *2/*2

Key exclusion criteria

1.History of cardiovascular disease
2.Severe hepatic or renal dysfunction
3.Volunteers who received other clinical study drug within 30 days
4.Woman who is pregnant or possibly be pregnant
5.History of severe allergy or allergic reaction to the drugs which are used in the present study
6.History of heart disease, glaucoma, peptic ulcer and aspirin-induced asthma
7.volunteers who have smoking habit 3 months before the start of this study
8.On medical treatment (exclude NSAIDs and sleeping pills taken as needed)
9.On medical treatment of phosphodiesterase 5 or agents with guanylate cyclase stimulating effect
10.systolic blood pressure<90 mmHg
11.Body weight <40 kg or >90 kg
12.Not appropriate to this study by other reasons

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Yoshihara

Organization

SOUSEIKAI Fukuoka Mirai Hospital

Division name

Clinical Research Center

Zip code


Address

3-5-1, Kashiiteriha, Higashi-ku, Fukuoka

TEL

092-662-3608

Email

tatsuya-yoshihara@lta-med.com


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Yoshihara

Organization

SOUSEIKAI Fukuoka Mirai Hospital

Division name

Clinical Research Center

Zip code


Address

3-5-1, Kashiiteriha, Higashi-ku, Fukuoka

TEL

092-662-3608

Homepage URL


Email

tatsuya-yoshihara@lta-med.com


Sponsor or person

Institute

SOUSEIKAI Fukuoka Mirai Hospital, Clinical Research Center

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Graduate School of Medical Sciences, Kyushu Umiversity

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

医療法人相生会 福岡みらい病院 臨床研究センター


Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 06 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 08 Month 03 Day

Date of IRB


Anticipated trial start date

2018 Year 08 Month 06 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

2018 Year 08 Month 06 Day

Last modified on

2019 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038230


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name