UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018842
Receipt number R000021486
Scientific Title 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 2022/07/21 11:54:00

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Basic information

Public title

Improvement effects of a food containing royal jelly hydrolysate on menopause symptom

Acronym

Improvement effects of a food containing royal jelly hydrolysate on menopause symptom

Scientific Title

Improvement effects of a food containing royal jelly hydrolysate on menopause symptom

Scientific Title:Acronym

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

1st name
Middle name
Last name Takashi Takeda

Organization

Research Institute of Traditional Asian Medicine, Kinki University

Division name

Women's health

Zip code


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

1st name
Middle name
Last name Hidenori Matsuzaki

Organization

Research Center for Immunological Analysis, Inc.

Division name

none

Zip code


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 or person

Institute

Research Center for Immunological Analysis, Inc.

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 31 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

2015 Year 07 Month 21 Day

Date of IRB

2015 Year 08 Month 07 Day

Anticipated trial start date

2015 Year 08 Month 29 Day

Last follow-up date

2016 Year 02 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 28 Day

Last modified on

2022 Year 07 Month 21 Day



Link to view the page

Value
https://center6.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