UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation studies of high dose intake of capsules including herb extract
Title of the study (Brief title)	Safety evaluation studies of high dose intake of capsules including herb extract
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive ingestion of foods containing herb extract, 5-fold quantity of recommended daily intake.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/ body mass index Doctor's questions Adverse event Evaluate at points of 2 week and 4 week of ingestion and 2 weeks after the end of ingestion period
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	Oral ingestion of the test product 10 grains per day, 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	20 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult males and females from 20 to 64 years of age
Key exclusion criteria	(1) Subjects who routinely use health food richly containing herb extract (2) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (3) Subjects having possibilities for emerging allergy related to the study (4) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required (5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (6) Subjects who have participated in other clinical studies (7) Subjects who intend to become pregnant or lactating (8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (9) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	10

Research contact person
Name of lead principal investigator	Hirohide Sakaguchi
Organization	Nippon Shinyaku Co.,Ltd.
Division name	Food Development Labs.
Address	14,Nishinosho-monguchi-cho,Kisshoin, Minami-ku,Kyoto
TEL	075-321-9027
Email	h.sakaguchi@po.nippon-shinyaku.co.jp

Public contact
Name of contact person	Kunihiko Wasaki
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.wasaki@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Nippon Shinyaku 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	2017 Year 09 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 24 Day
Anticipated trial start date	2017 Year 09 Month 08 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	2017 Year 09 Month 04 Day
Last modified on	2018 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033166