UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025843
Receipt number R000029718
Scientific Title Inositol treatment for polycystic ovary syndrome (PCOS): Systematic review and meta-analysis
Date of disclosure of the study information 2017/02/01
Last modified on 2019/01/10 17:43:15

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Basic information

Public title

Inositol treatment for polycystic ovary syndrome (PCOS): Systematic review and meta-analysis

Acronym

Inositol treatment for PCOS

Scientific Title

Inositol treatment for polycystic ovary syndrome (PCOS): Systematic review and meta-analysis

Scientific Title:Acronym

Inositol treatment for PCOS

Region

Japan


Condition

Condition

polycystic ovary syndrome

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of inositol on outcome in PCOS.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Parameters of glucose metabolism
Ovarian function

Key secondary outcomes

Serum sex hormone


Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

All randomized controlled trial comparing inositol with placebo intake in PCOS are included in this study.

Key exclusion criteria

We exclude studies that is not report our primary and secondary outcomes.
We also exclude studies that did not set appropriate control group, is review article and is not clinical study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Nakano

Organization

Yokohama University of Pharmacy

Division name

General Health Medical Center

Zip code


Address

601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN

TEL

045-859-1300

Email

m.nakano@hamayaku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kohsuke Hayamizu

Organization

Yokohama University of Pharmacy

Division name

Laboratory of Food Chemistry

Zip code


Address

601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN

TEL

045-859-1300

Homepage URL


Email

k.hayamizu@hamayaku.ac.jp


Sponsor or person

Institute

Yokohama University of Pharmacy

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2017 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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 01 Month 13 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Preparing to submit a paper


Management information

Registered date

2017 Year 01 Month 25 Day

Last modified on

2019 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name