UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027691 |
|---|---|
| Receipt number | 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 | 2019/12/09 10:05:43 |
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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
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
hiroshi-tsukikawa@lta-med.com
Sponsor or person
Institute
Medical Co. LTA Fukuoka Mirai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031719
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
