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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027691
Receipt No. R000031719
Scientific Title Effect of a functional food "SNR-11" supplementation on unidentified complaints in premenopausal healthy women: A randomized, double-blind, and placebo-controlled trial
Date of disclosure of the study information 2019/05/24
Last modified on 2017/12/08

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Basic information
Public title Effect of a functional food "SNR-11" supplementation on unidentified complaints in premenopausal healthy women: A randomized, double-blind, and placebo-controlled trial
Acronym Effect of a functional food "SNR-11" supplementation on unidentified complaints
Scientific Title Effect of a functional food "SNR-11" supplementation on unidentified complaints in premenopausal healthy women: A randomized, double-blind, and placebo-controlled trial
Scientific Title:Acronym Effect of a functional food "SNR-11" supplementation on unidentified complaints
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of continuous supplementation of SNR-11 on unidentified complaints in premenopausal healthy women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS values of unidentified complaints on day 6, 7, 8 of supplementation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Group A; 1st phase: Oral intake of SNR-11, once a day for 7 days - washed out - 2nd phase: Oral intake of Placebo once a day for 7 days
Interventions/Control_2 Group B; 1st phase: Oral intake of Placebo, once a day for 7 days - washed out - 2nd phase: Oral intake of SNR-11 once a day 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

Not applicable
Gender Female
Key inclusion criteria Premenopausal healthy women with normal menstrual cycle
Key exclusion criteria Individuals who are allergic or intolerant to foods
Individuals who have abnormalities to be enrolled
Individuals who are or may be pregnant and nursing
Individuals who are diagnosed inappropriate for the trial by the principal investigator
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Hamada
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Saga Nutraceuthicals Research Institute
Zip code
Address 5006-5 Yoshinogari, Kanzaki, Saga
TEL 0952-52-1522
Email Hamada.Koichiro@otsuka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Tsukikawa
Organization Medical Co. LTA Fukuoka Mirai Hospital Clinical Research Center
Division name Planning and Coordination Dept
Zip code
Address 3-5-1, Kashiiteriha, Higashi-ku, FUKUOKA
TEL 092-662-3608
Homepage URL
Email hiroshi-tsukikawa@lta-med.com

Sponsor
Institute Medical Co. LTA Fukuoka Mirai Hospital
Institute
Department

Funding Source
Organization Otsuka 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)

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

Other administrative information
Date of disclosure of the study information
2019 Year 05 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 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
2017 Year 06 Month 08 Day
Last modified on
2017 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031719

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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