UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060506 |
|---|---|
| Receipt number | R000067137 |
| Scientific Title | Human studies on the immune function of Sendan alpha (Melia azedarach) |
| Date of disclosure of the study information | 2026/01/29 |
| Last modified on | 2026/01/29 08:59:30 |
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Basic information
Public title
Human studies on the immune function of Sendan alpha
Acronym
Human studies on the immune function of Sendan alpha
Scientific Title
Human studies on the immune function of Sendan alpha (Melia azedarach)
Scientific Title:Acronym
Human studies on the immune function of Sendan alpha
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sendan alpha is a product containing extracts derived from the plant Melia azedarach, and has been shown to have potent anti-cancer activity in human tumor cells and in mouse and dog tumor models. Sendan alpha is also sold as a supplement claiming to have immune-modulating and anti-tumor effects, but scientific proof from large-scale human clinical trials is still insufficient. Therefore, we decided to conduct a human trial of Sendan alpha and examine the immunostimulatory effects of this product on immune function through blood tests.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NK cell activity
Key secondary outcomes
IgA, IgG, CH50, IL-2R
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The test product used was commercially available Sendan alpha (a 50ml bottle containing 2.5mg of Melia azedarach leaf extract, as well as small amounts of erythrityl, monk fruit extract/seasoning (amino acids, etc.), acidulant, flavouring (derived from apple), sweetener (stevia, acesulfame K), L-arginine, preservative (sodium benzoate), calcium pantothenate, nicotinamide, and vitamins B1, B6 and B2).
Interventions/Control_2
The diluted product used is commercially available Sendan alpha (a 50ml bottle contains 1.5mg of Melia azedarach leaf extract, and also contains small amounts of erythrityl, monk fruit extract/seasoning (amino acids, etc.), acidulant, flavouring (derived from apple), sweetener (stevia, acesulfame potassium), L-arginine, preservative (sodium benzoate), calcium pantothenate, nicotinamide, and vitamins B1, B6 and B2).
Interventions/Control_3
The placebo does not contain Melia azedarach leaf extract, but the other ingredients are the same as those of the test product.
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
| 50 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women aged 50-79
Key exclusion criteria
Participants who meet any of the following criteria will be excluded:
1. Participants currently undergoing treatment for neoplastic, infectious, or immune-related diseases.
2. Participants who consume specified health foods, health foods, supplements, or nutritional drinks daily or frequently.
3. Participants with food or drug allergies.
4. Participants with difficulty communicating.
5. Participants whose physicians have otherwise determined that enrollment in this study is inappropriate.
Target sample size
60
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 Knight' Laboratory Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NEROME INSTITUTE OF BIOLOGICAL RESOURCES
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
| 2026 | Year | 01 | Month | 29 | 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
60
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 | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 29 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067137
