UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059713 |
|---|---|
| Receipt number | R000067132 |
| Scientific Title | Human safety test of Macaranga tanarius fruit extract |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 09:53:25 |
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Basic information
Public title
Human safety test of Macaranga tanarius fruit extract
Acronym
Human safety test of Macaranga tanarius fruit extract
Scientific Title
Human safety test of Macaranga tanarius fruit extract
Scientific Title:Acronym
Human safety test of Macaranga tanarius fruit extract
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Macaranga tanarius (scientific name: Macaranga tanarius) grows wild south of the Ryukyu Islands. The prenylflavonoids contained in Macaranga tanarius exhibit strong antibacterial and antioxidant properties, and have been reported to have antibacterial, anti-inflammatory, antioxidant, anti-cancer properties, promote glucose uptake in skeletal muscle cells, and promote tooth germ formation.
Furthermore, Macaranga tanarius fruit ethanol extract has been shown to suppress weight gain and blood sugar levels in obese and diabetic model mice. Safety tests showed no safety issues when administered to rats and mice at 2g/kg of Macaranga tanarius fruit extract (test product). Thus, if Macaranga tanarius fruit extract is commercialized, it is expected to promote health through its anti-inflammatory, blood sugar-lowering, and anti-obesity properties. Therefore, in this study, we first conducted human safety tests.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
General blood tests and blood biochemistry tests
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
The test product will be a No. 2 hard capsule (made of hydroxypropyl methylcellulose) containing 100 mg of Macaranga tanarius fruit extract.
The administration period will generally be four weeks, and the drug will be taken once daily in the morning.
Interventions/Control_2
The placebo will be a No. 2 hard capsule containing dextrin.
The administration period will generally be four weeks, and the drug will be taken once daily in the morning.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Basically, healthy men and women aged 20 to 65
Key exclusion criteria
Participants who meet any of the following criteria will be excluded.
1) Participants currently receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction.
2) Participants with a pacemaker or implantable cardioverter-defibrillator.
3) Participants currently receiving treatment for the following chronic diseases: arrhythmia, liver damage, chronic kidney disease, cerebrovascular disease, rheumatic disease, diabetes,
dyslipidemia, hypertension, cardiovascular disease, and other chronic diseases.
4) Participants currently taking foods for specified health uses or foods with functional claims.
5) Participants currently taking or using medicines (including herbal medicines) or supplements.
6) Participants with allergies (to medicines or foods related to the test food).
7) Participants currently pregnant, breastfeeding, or intending to become pregnant during the study period.
8) Participants who have participated in other clinical trials within the 28 days prior to the consent acquisition date,
or who plan to participate in such trials during the study period.
9) Participants deemed inappropriate for this study by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Southen Knights' Laboratory Co., Ltd.
Division name
Representative Director
Zip code
904-0113
Address
823 Arture Mihama, 1-1 Miyagi, Chatan, Okinawa, Japan
TEL
09049987459
sugaya0822@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Southen Knights' Laboratory Co., Ltd.
Division name
Representative Director
Zip code
904-0113
Address
823 Arture Mihama, 1-1 Miyagi, Chatan, Okinawa, Japan
TEL
09049987459
Homepage URL
sugaya0822@yahoo.co.jp
Sponsor or person
Institute
Southen Knights' Laboratory Co., Ltd.
Institute
Department
Personal name
Kimio Sugaya
Funding Source
Organization
Natu Pharma Ryukyu Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendan Medical Corporation Kitakami Central Hospital Ethics Committee
Address
631-9 Kamisedo, Chatan, Okinawa, Japan
Tel
0989365111
kitakami@ryucom.ne.jp
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
| 2025 | Year | 11 | Month | 10 | 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
30
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
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
| 2025 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067132
