UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 06 Month 02 Day
Date of IRB	2017 Year 06 Month 02 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2019 Year 11 Month 06 Day
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	2019 Year 12 Month 09 Day

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