UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046674 |
|---|---|
| Receipt number | R000053021 |
| Scientific Title | The effects of ingestion of Panax genus plants, extracts, or ginsenosides intake on muscle damage- A systematic review with Meta-analysis. |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/07/21 10:30:28 |
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Basic information
Public title
The effects of ingestion of Panax genus plants, extracts, or ginsenosides intake on muscle damage- 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 ginsenosides intake on muscle damage- A systematic review with Meta-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 muscle damage after exercise 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
Serum creatine kinase as marker for muscle damage.
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: Serum creatine kinase as marker for muscle damage.
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 or illness which impact their physical exercise ability or their serum creatine kinase. 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 disease which impact their physical exercise ability or their serum creatine kinase: central nervous system, muscular, 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
40
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
+81847526262
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
+81847526262
Homepage URL
s-ikeuchi@maruzenpcy.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
None
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
-
-
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
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053021
Publication of results
Published
Result
URL related to results and publications
https://www.pieronline.jp/content/article/0386-3603/51010/47
Number of participants that the trial has enrolled
201
Results
Seven studies met the inclusion criteria. The number of participants was 201, with 105 in the ingestion-Panax genus plants(PGPs) group and 104 in the controlgroup, because including crossover-design trials. Ingestion of PGPs group significantly suppresses the elevated serum creatin kinase(CK) 72 hours after exercise (SMD, 0.58; 95% CI, 0.22-0.95) but with a high I2 value (I2=91%), and not 60 min or 24 hours.
Results date posted
| 2023 | Year | 07 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 20 | Day |
Baseline Characteristics
The participants of this systematic review were 'healthy adults (> 18 years old) who had no underlying problems (dysfunction or diseases), had no children; not pregnant or planning to conceive, and were not breastfeeding'. People younger than 18 years old were excluded as they were still in the growth phase and their serum CK data might have influenced the results. People who had any acute or chronic diseases which affects serum CK, such as diseases of the cardiovascular were excluded. However, people who have diseases related to the motor function of the limbs but have the capacity to physically exercise were included.
Participant flow
We searched the literature along with the PICOS mentioned above, and limitations were not set for the year of publication, language, form of publication, or for the retrieval of the complete article. However, we searched literature in English and Japanese because we could not adequately understand other languages. We also searched gray literature, including academic abstracts, administrative documents, and other forms of documents or literature.
The data on studies in English literature databases (Web of science, SCOPUS, PubMed, Cochrane Library, and AGRIS), English and Japanese literature databases (J-Dream3 and Ichu-shi Web), and clinical trial registration databases (ICTRP, ClinicalTrials.gov, ISRCTN, and UMIN-CTR) were planned to be collected by reviewer SI and researcher MK, and to be manually searched in journals and general web search engines (Google, Yahoo! JAPAN, and Bing) and possessed by reviewers SI and MM. We planned to contact the corresponding authors if it was possible, because of the lack of data and other reasons.
We selected studies based on their titles and abstracts.
Exclusion criteria were:
1. Reports using effective materials other than PGPs or ginsenoside.
2. The PICOS criteria are not met.
3. The study is an in vitro or in vivo animal (not human) test.
After screening, each article content was checked to assess the selection criteria. Screening and checking articles were conducted by reviewers S.I. and M.M. individually and selected if there was consensus and no conflicts. However, if a conflict of opinion occurred between the reviewers, the article was selected based on consensus with T.N.
Adverse events
In the literature included in this study, PGPs, or their extracts were considered to be safe because no adverse events were reported. The participants of six studies were adults (20-40 years old), had no diseases, and consumed no medication. On the other hand, Yi et al 18). recruited middle-aged people (51.80 +- 12.03 years old in the test group and 53.02 +- 9.54 years old in the placebo group). Accordingly, ingestion of PGPs was considered safe and effective. Thus, the benefits outweigh the harms. Since the supporting evidence for this conclusion, we need to conduct more clinical trials, specifically studies in elderly people, to validate the efficacy and safety of PGPs.
Outcome measures
The primary outcome was `blood serum CK after exercise'. There were no secondary outcomes. Studies that performed load exercise workload (resistance exercise or aerobic exercise) as an intervention were included. On the other hand, studies that did not perform load exercise workload were excluded.
We evaluated the data at 60 min, 24 hours, and 72 hours after exercise because serum CK levels change by time after exercise.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 25 | 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 11 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 5.4. 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
| 2022 | Year | 01 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053021
