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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018842
Receipt No. R000021486
Official scientific title of the study Improvement effects of a food containing royal jelly hydrolysate on menopause symptom
Date of disclosure of the study information 2016/03/31
Last modified on 2016/03/01

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Basic information
Official scientific title of the study Improvement effects of a food containing royal jelly hydrolysate on menopause symptom
Title of the study (Brief title) Improvement effects of a food containing royal jelly hydrolysate on menopause symptom
Region
Japan

Condition
Condition menopause symptom
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine improvement effects of a food containing royal jelly hydrolysate on menopause symptom.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire for Assessment of menopause symptom in japanese women (question number: 5, 12, 17, 18) (Visual Analog Scale)
Key secondary outcomes Questionnaire for Assessment of menopause symptom in japanese women (question number: 1,2,3,4,6,7,8,9,10,11,13,14,15,16,19,20,21) (Visual Analog Scale)

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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test product (4T/day, 12weeks)
Interventions/Control_2 Oral ingestion of the test product (4T/day, 12weeks)
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
50 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria [1] Japanese females at least 50 years of age but not older than or equal to 60 at the time of informed consent
[2] Individuals who occured natural menopause in the past 5 years
[3] Individuals judged approproate for the study by the principal
[4] Individuals who scored less than or equal to 65 on the simplified Menopausal Index score
[5] Individuals who scored less than or equal to 49 on the self-rating depression scale score , and a score of suicidal ideation is 1
Key exclusion criteria [1] Individuals judged to require treatment for menopause symptom including medicament therapy
[2] Individuals who are treated for menopause symptom or menopausal disorder
[3] Individuals who has been diagnosed with menopausal disorder
[4] Individuals who had a habit to ingest drugs, health-promoting foods, foods for specified health uses, health foods, or supplements affecting menopause symptom or test results in the past 3 month or will ingest those drugs or foods during the test peripd
[5] Individuals who have or had an allergy or asthma to food or drug
[6] Individuals who have a disease needing immediate treatment or serious complication
[7] Individuals who have or had a digestive disorder that effects digestion and absorption
[8] Individuals who have a history of breast cancer, uterine cancer, or hormone dependent cancer
[9] Individuals who have a history of serious liver disease, Kidney disease, heart disease, lung disease, or blood disease
[10] Individuals who have a mental disorder
[11] Individuals who have an anamnesis or a history of present illness of drug dependence or alcohol dependence
[12] Individuals who participated in other clinical studies in the past 3months
[13] Individuals who are or are possibly pregnant, or are lactating
[14] Individuals judged inappropriate for the study by the principal
Target sample size 42

Research contact person
Name of lead principal investigator Takashi Takeda
Organization Research Institute of Traditional Asian Medicine, Kinki University
Division name Women's health
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL 072-366-0221
Email take@med.kindai.ac.jp

Public contact
Name of contact person Hidenori Matsuzaki
Organization Research Center for Immunological Analysis, Inc.
Division name none
Address Okayama Research Park Incubation Center 213, 5303, Haga, Kita-Ku, Okayama-shi, Okayama, 701-1221, Ja
TEL 086-286-9333
Homepage URL
Email info@menekibunseki.com

Sponsor
Institute Research Center for Immunological Analysis, Inc.
Institute
Department

Funding Source
Organization Yamada Bee Farm Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2016 Year 03 Month 31 Day

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 07 Month 21 Day
Anticipated trial start date
2015 Year 08 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2015 Year 08 Month 28 Day
Last modified on
2016 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021486

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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