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

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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 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

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

Value
https://center6.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