UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044104 |
|---|---|
| Receipt number | 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 10:07:24 |
* 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
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
drjoakl@gmail.com
Sponsor or person
Institute
BTC Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050337
