UMIN-CTR Clinical Trial

Basic information
Public title	A systematic review of the effects of pine bark intake on quality of life in menopausal women
Acronym	A systematic review of the effects of pine bark intake on quality of life in menopausal women
Scientific Title	A systematic review of the effects of pine bark intake on quality of life in menopausal women
Scientific Title:Acronym	A systematic review of the effects of pine bark intake on quality of life in menopausal women
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of pine bark intake on quality of life in healthy menopausal women.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quality of life
Key secondary outcomes

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	40 years-old <=
Age-upper limit	90 years-old >
Gender	Female
Key inclusion criteria	Healthy adult femele
Key exclusion criteria	Sick Person
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Key Middle name Last name Mochida
Organization	RCT Japan Co., Ltd.
Division name	R&D
Zip code	150-0002
Address	Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan
TEL	03-3400-3200
Email	info@rctjapan.org

Public contact
Name of contact person	1st name Key Middle name Last name Mochida
Organization	RCT Japan Co., Ltd.
Division name	R&D
Zip code	150-0002
Address	Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan
TEL	03-3400-3200
Homepage URL
Email	info@rctjapan.org

Sponsor
Institute	Kino-Ken
Institute
Department

Funding Source
Organization	RCT Japan 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	RCT Japan Co., Ltd.
Address	Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan
Tel	03-3400-3200
Email	info@rctjapan.org

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	2022 Year 10 Month 19 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date	2022 Year 10 Month 19 Day
Last follow-up date	2023 Year 10 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Key words: menopaudr, quolity of life, pine bark

Management information
Registered date	2022 Year 10 Month 17 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056075