UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the safety of excessive consumption of saw palmetto extract.
Title of the study (Brief title)	A clinical study for evaluating the safety of excessive consumption of saw palmetto extract.
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive consumption of saw palmetto extract
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Doctor's questions, Physical measurement, Physical examination, Blood test, Urinalysis, Adverse event
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Saw palmetto extract, 4 weeks excessive consumption
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	20 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females aged 20 to 64 years-old. (2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects who were diagnosed with serious disease (e.g., liver disease, kidney disease, digestive disease, heart disease, and/or peripheral vascular disease). (2) Subjects with abnormal parameters in liver and/or kidney function. (3) Subjects who had a gastrointestinal surgery. (4) Subjects with a disease currently under treatment. (5) Subjects with anemic. (6) Subjects who play high intensity sports and/or are on a diet. (7) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods. (8) Subjects who are under treatment with medications (including OTC or prescribed medication). (9) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement. (10) Subjects who are planning to become pregnant after imformed consent for the current study, pregnant or lactating. (11) Subjects who are participating in other studies or planning to participate during the current study period. (12) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	22

Research contact person
Name of lead principal investigator	Naoki Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Japan
TEL	06-6135-5200
Email	mterashima@miula.co.jp

Public contact
Name of contact person	Makoto Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Japan
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Oneness support Co., Ltd.
Institute
Department

Funding Source
Organization	BGG 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)

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	2019 Year 10 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 23 Day
Anticipated trial start date	2018 Year 07 Month 30 Day
Last follow-up date
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	2018 Year 07 Month 27 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038242