UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of a herbal drug "Kyushin capsule F" on indefinite complains in women experiencing typical symptom of menopause
Title of the study (Brief title)	Effect of "Kyushin capsule F" on indefinite complains
Region	Japan

Condition
Condition	indefinite complains
Classification by specialty	Cardiology Endocrinology and Metabolism Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	confirm effectiveness of "Kyushin capsule F" on indefinite complains of women experiencing typical symptom of menopause
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	improvement factor of indefinite complains (on 2 weeks and 4 weeks after first administration)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	one capsule 3 times a day for 4 weeks
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	Not applicable
Gender	Female
Key inclusion criteria	Simplified menopause score has over 26
Key exclusion criteria	under treatment by other medicine
Target sample size	20

Research contact person
Name of lead principal investigator	Keiichi Sudoh
Organization	Kyushin Pharmaceutical Co., Ltd.
Division name	Research and development
Address	1-22-10 Wada Suginami-ku Tokyo
TEL	03-5385-3211
Email	sudo@kyushin.co.jp

Public contact
Name of contact person	Yasuharu Shimizu
Organization	Kyushin Pharmaceutical Co., Ltd.
Division name	Research and development
Address	1-22-10 Wada Suginami-ku Tokyo
TEL	03-5385-3211
Homepage URL
Email	y-shimizu@kyushin.co.jp

Sponsor
Institute	CPCC Co., Ltd.
Institute
Department

Funding Source
Organization	Kyushin Pharmaceutical Co., Ltd.
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	チヨダパラメディカルケアクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 01 Month 30 Day
Last follow-up date	2017 Year 02 Month 27 Day
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	2017 Year 01 Month 18 Day
Last modified on	2017 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029606