UMIN-CTR Clinical Trial

Basic information
Public title	The effects of ingestion of Panax genus plants, extracts, or ginsenosides intake on exercise endurance- A systematic review with Meta-analysis.
Acronym	A systematic review of Panax genus plants or ginsenosides.
Scientific Title	The effects of ingestion of Panax genus plants, extracts, or ginseno-sides intake on exercise endurance- A systematic review with Me-ta-analysis.
Scientific Title:Acronym	A systematic review of Panax genus plants or ginsenosides.
Region	Japan

Condition
Condition	Adult volunteers who have no problems with motor and metabolic functions.
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The object of this review is to evaluate the effect on exercise endurance by ingestion of food containing Panax genus plants, extracts or ginsenosides compared with the intake of placebo food.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Exercise endurance.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Participants: Adult volunteers who have no problems with motor and metabolic functions. *1 Intervention: One-time or continuous intake of food containing Panax genus plants, or their extract (more than 100mg/day), or ginsenosides (more than 4mg/day) *2 Comparison: Intake of placebo food. Outcome: Primary outcome: exercise endurance. Study design: randomized, double-blind, placebo-controlled parallel group trial / randomized, double-blinded, placebo-controlled cross-over trial/ quasi-randomized, double-blind, placebo-controlled controlled trial. The literature to be included will be made up of original papers, information on clinical trial registered databases, abstracts, and grey literature. The keywords used in the literature search will be in English or Japanese only. Hand-search will also be conducted on some scientific journals. *1: Studies with participants who have characteristic exercise ability like athletes, belong sports teams or military will be included but will be subgroup analysis. Studies with participants who have disease or illness will be included, except those affected by disease impacting their physical exercise ability. Participants with diseases related to motor function of the limbs judged to have physical exercise ability will be included. *2: According to previous study, single intake and continuous intake up to 12 weeks was included.
Key exclusion criteria	Literature which does not meet key inclusion criteria will be excluded. Participants who are planning or currently pregnant or breastfeeding, and children (persons under 18 years), will be excluded from this study. If participants have conditions such as any acute or chronic diseases: cardiovascular, pulmonary, endocrine system, gastrointestinal system, and other organ dysfunction, or cancer, they will be excluded. The studies will be excluded from using special dosage form food like foods to avoid digestion or absorption by the gastrointestinal system as intervention foods. For the control group, no intervention is excluded. Literature not written in English or Japanese will be excluded due to inability to verify and perform data extraction.
Target sample size

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Ikeuchi
Organization	Maruzen Pharmaceuticals Co.,Ltd.
Division name	Research & Development div.
Zip code	729-3102
Address	1089-8, Sagata, Shinnichi-cho, Fukuyama city, Hiroshima, Japan
TEL	0847526262
Email	s-ikeuchi@maruzenpcy.co.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Ikeuchi
Organization	Maruzen Pharmaceuticals Co.,Ltd.
Division name	Research & Development div.
Zip code	729-3102
Address	1089-8, Sagata, Shinnichi-cho, Fukuyama city, Hiroshima, Japan
TEL	0847526262
Homepage URL
Email	s-ikeuchi@maruzenpcy.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., LTD.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Professor Hiroharu Kamioka, Graduate School of Tokyo University of Agriculture The lead principal investigator is enrolled in the doctoral program at the Graduate School of Tokyo University of Agriculture.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NA
Address	NA
Tel	NA
Email	NA@NA

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 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/2072-6643/14/6/1185
Number of participants that the trial has enrolled	123
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	Main results already published
Date of protocol fixation	2021 Year 02 Month 15 Day
Date of IRB	2021 Year 02 Month 15 Day
Anticipated trial start date	2021 Year 02 Month 15 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(Search) Reviewer A, searcher B, and an outsourcing searcher will search 12 databases and 3 internet search engines for studies from the beginning of each database to the search date. Reviewers A and C will independently search journals in the possession of Maruzen Pharmaceuticals Co., Ltd. (Data extraction) Reviewers A and C will independently apply all criteria to the full text of articles that have passed the first eligibility screening. Disagreement and uncertainties will be resolved by discussion with researcher D. (Risk of bias assessment and Indirectness evaluation) Reviewers A and C will independently assess the quality of articles and evaluate the indirectness of articles. A full quality appraisal of these papers will be made using a check list (7 items) from the Cochrane Handbook for interventional trials. Disagreements and uncertainties will be resolved by discussion with researcher D. (Meta-analysis) Only when no or limited heterogeneity is found in multiple randomized controlled trials, will reviewers A and C perform a meta-analysis of Panax species using RevMan 5.3. After the meta-analysis is carried out, the results will be confirmed by research collaborator E, who is an expert in systematic review. Meta-analysis will be conducted with a random effect model considering the differences among studies, using standardized mean difference for effect estimate and 95%CI. Estimated heterogeneity will be judged with forest plot, P or Cochrane Q, and I2. Additional analysis will be performed according to the characteristics of the literature to be evaluated. (Other bias risk) Imprecision, inconsistency, and publication bias of this study will be evaluated with the GRADE system. (Protocol) The protocol of this study cannot be completely explained here because of limitations of this site. Protocol details are archived at the organization of the "Principal investigator". For full protocol details, contact the "Contact person" directly.

Management information
Registered date	2021 Year 02 Month 16 Day
Last modified on	2022 Year 03 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049484