UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054724 |
|---|---|
| Receipt number | R000062525 |
| Scientific Title | Study to confirm the safety of continuous intake of diosgenin |
| Date of disclosure of the study information | 2024/06/21 |
| Last modified on | 2025/01/10 12:45:29 |
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Basic information
Public title
Study to confirm the safety of continuous intake of diosgenin
Acronym
Study to confirm the safety of continuous intake of diosgenin
Scientific Title
Study to confirm the safety of continuous intake of diosgenin
Scientific Title:Acronym
Study to confirm the safety of continuous intake of diosgenin
Region
| Japan |
Condition
Condition
Healthy male/female volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this clinical trial is to examine the safety of diosgenin in healthy adult male and female subjects given continuously intake of diosgenin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events and side effects, including abnormal changes in laboratory values.
Key secondary outcomes
Body measurements: weight, BMI and blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of tablets containing diosgenin
Interventions/Control_2
Intake of soft capsules containing diosgenin
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Japanese male and female aged 40 years and older at the time of informed consent
2) Females must be menopausal
3) Subjects who have been fully informed of the purpose and content of the study and who have signed a consent form prior to the start of the study
Key exclusion criteria
1)Non-menopausal women
2)Subjects on medication due to a history or current history of intestinal disease (irritable bowel syndrome, Crohn's disease), liver disease, renal disease, cardiovascular disease (brain and heart), diabetes, dyslipidemia, hypertension, epileptic seizures, sleep apnea syndrome, or other chronic diseases
3)Subjects with a history of gastrointestinal tract surgery (except for appendectomy)
4)Subjects who are regularly using health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items
5)Subjects who are unable to discontinue the intake of pharmaceuticals (excluding intravenous administration), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study
6)Heavy alcohol drinkers (average net alcohol consumption: 60 g/day or more)
7)Subjects who have an extremely irregular eating habits
8)Shift or night shift workers
9)Regular users of any kind of medication (including intestinal medicines, herbal medicines, and OTC drugs)
10)Subjects who plan to take any medication during the period of consumption of the test food (including painkillers such as headache medication)
11)Subjects who are allergic to yams
12)Subjects with perennial atopic dermatitis or allergy (e.g. rhinitis)
13)Subjects with a history of anaphylactic shock in the past
14)Subjects who are deemed inappropriate by the investigators and sub investigators
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kuriyama |
Organization
Anti-Aging Pro, Co., Ltd
Division name
Research and Development Division
Zip code
151-0053
Address
1-57-2 Yoyogi,Shibuya-ku,Tokyo,Japan
TEL
03-6300-0816
kuri@a2-pro.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Otake |
Organization
feileB Co., Ltd
Division name
Clinical Research Support dev.
Zip code
170-0013
Address
1-18-1 Higashiikebukuro Toshima-ku Tokyo Japan
TEL
03-4332-1770
Homepage URL
otake@feileb.jp
Sponsor or person
Institute
NihonbashiSakura Clinic
Institute
Department
Personal name
Funding Source
Organization
Anti-Aging Pro Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NISHI-UMEDA Clinic for Asian Medical Collaboration Ethics Review Committee
Address
Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, Kita-ku, Osaka, Osaka, Japan
Tel
06-4797-5660
morimoto@amc-clinic.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
| 2024 | Year | 06 | Month | 21 | 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
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
| 2024 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062525
