UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009282
Receipt number R000010832
Scientific Title Efficacy of Royal jelly in women with premenstrual syndrome: A randomized controlled pilot study
Date of disclosure of the study information 2013/01/01
Last modified on 2016/05/10 14:40:50

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Basic information

Public title

Efficacy of Royal jelly in women with premenstrual syndrome: A randomized controlled pilot study

Acronym

Efficacy of Royal jelly in women with premenstrual syndrome

Scientific Title

Efficacy of Royal jelly in women with premenstrual syndrome: A randomized controlled pilot study

Scientific Title:Acronym

Efficacy of Royal jelly in women with premenstrual syndrome

Region

Japan


Condition

Condition

PMS

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of Royal Jelly versus placebo on PMS symptoms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Severity of PMS/PMDD

Key secondary outcomes

Severity of PMS symptoms
Salivary cortisol
Salivary amylase


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Control (placebo)

Interventions/Control_2

Royal jelly 8T/day

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

45 years-old >=

Gender

Female

Key inclusion criteria

PMS symptoms (moderate to severe PMS or PMDD)
Regular menstrual cycles (25-38 days)

Key exclusion criteria

Severe complication (liver disease, kidney disease, heart disease, lung disease, blood disease, malignancy, etc.)

Asthma, food allergy
Psychiatric disease

Target sample size

72


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&#39;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 Takashi Takeda

Organization

Research Institute of Traditional Asian Medicine, Kinki University

Division name

Women&#39;s health

Zip code


Address

377-2, Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan

TEL

072-366-0221

Homepage URL


Email

take@med.kindai.ac.jp


Sponsor or person

Institute

Research Institute of Traditional Asian Medicine, Kinki University

Institute

Department

Personal name



Funding Source

Organization

Yamada bee farm

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

近畿大学東洋医学研究所(大阪府)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 01 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

2012 Year 11 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2015 Year 11 Month 30 Day

Date of closure to data entry

2015 Year 12 Month 31 Day

Date trial data considered complete

2015 Year 12 Month 31 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 11 Month 07 Day

Last modified on

2016 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010832


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name