UMIN-CTR Clinical Trial

Basic information
Public title	A human trial to evaluate the efficacy and safety of Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder on improvement of exercise performance
Acronym	A human trial to evaluate the efficacy and safety of Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder on improvement of exercise performance
Scientific Title	A human trial to evaluate the efficacy and safety of Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder on improvement of exercise performance
Scientific Title:Acronym	A human trial to evaluate the efficacy and safety of Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder on improvement of exercise performance
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	Evaluation of the efficacy and safety of Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder on improvement of exercise performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood index related to exercise performance
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder group: 2 capsules once daily, after breakfast for 12 weeks{700 mg/day, 450 mg/day for Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder}
Interventions/Control_2	Placebo group: 2 capsules once daily, after breakfast for 12 weeks(700 mg/day for placebo)
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	19 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Adult males and females aged 19 to 60 at the screening test 2) Persons who have agreed to exercise test
Key exclusion criteria	1) Participants who have problems in results about exercise test 2) Participants who have Body Mass Index(BMI) less than 18.5 kg/m^2 or more than 35 kg/m^2 3) Participants who have taken medication or dietary supplements related to the improvement of exercise performance within 3 months prior to screening 4) Participants who have participated in the other human trials within 3 months before the screening test 5) Participants who are judged by the investigator to be ineligible to participate in the study due to other reasons including the results of laboratory test
Target sample size	100

Research contact person
Name of lead principal investigator	1st name KYUNGLIM Middle name Last name JOA
Organization	Inha University Hospital
Division name	Department of Rehabilitation Medicine
Zip code	22332
Address	27 Inhang-ro, Jung-gu, Incheon
TEL	820328902480
Email	drjoakl@gmail.com

Public contact
Name of contact person	1st name KYUNGLIM Middle name Last name JOA
Organization	Inha University Hospital
Division name	Department of Rehabilitation Medicine
Zip code	22332
Address	27 Inhang-ro, Jung-gu, Incheon
TEL	820328902480
Homepage URL
Email	drjoakl@gmail.com

Sponsor
Institute	BTC Corporation
Institute
Department

Funding Source
Organization	BTC Corporation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Inha University Hospital,Institutional Review Board
Address	27, Inhang-ro, Jung-gu, Incheon
Tel	820328903691
Email	irb@inhauh.com

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	2021 Year 05 Month 04 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	100
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	2020 Year 02 Month 06 Day
Date of IRB	2019 Year 12 Month 23 Day
Anticipated trial start date	2020 Year 02 Month 06 Day
Last follow-up date	2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 04 Day
Last modified on	2021 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050337