UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044104
Receipt No. R000050337
Scientific Title A human trial to evaluate the efficacy and safety of Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder on improvement of exercise performance
Date of disclosure of the study information 2021/05/04
Last modified on 2021/05/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.