UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060796 |
|---|---|
| Receipt number | R000069493 |
| Scientific Title | A Clinical Study Evaluating Cordyceps cicadae Mycelium Supplementation for Ocular and Nasal Discomfort - A Randomized, Double-Blind, Placebo-controlled Parallel-Group Trial - |
| Date of disclosure of the study information | 2026/03/03 |
| Last modified on | 2026/03/02 10:17:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Clinical Study Evaluating Cordyceps cicadae Mycelium Supplementation for Ocular and Nasal Discomfort - A Randomized, Double-Blind, Placebo-controlled Parallel-Group Trial -
Acronym
A Clinical Study Evaluating Cordyceps cicadae Mycelium Supplementation for Ocular and Nasal Discomfort
Scientific Title
A Clinical Study Evaluating Cordyceps cicadae Mycelium Supplementation for Ocular and Nasal Discomfort - A Randomized, Double-Blind, Placebo-controlled Parallel-Group Trial -
Scientific Title:Acronym
A Clinical Study Evaluating Cordyceps cicadae Mycelium Supplementation for Ocular and Nasal Discomfort
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of the study food on alleviating ocular and nasal discomfort in healthy Japanese men and women aged 20 to 65 who experience such symptoms due to pollen, dust, or house dust.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JRQLQ questionnaire, before and after intake of the test food capsules
Key secondary outcomes
Blood tests (histamine levels, white blood cell count and differential), nasal eosinophil count, and allergy symptom questionnaires, before and after intake of the test food capsules
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants take two capsules of the test food once daily with water, for 4 weeks.
Interventions/Control_2
Participants take two capsules of placebo food once daily with water, for 4 weeks.
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
1. Aged 20 to 65 years
2. Japanese men and women
3. BMI less than 30.0 kg/m^2
4. Experience hay fever symptoms every March-April and, at consent, meet one of the following:
a. Healthy: Have had ocular/nasal allergic reactions to pollen, dust, or house dust for the past two years and have not used allergy medication
b. Mild: Have had ocular/nasal allergic reactions to pollen, dust, or house dust for the past two years and occasionally* use allergy medication (not regularly*)
*Occasionally: Used as needed, less than three times per week, only when symptoms are severe
*Regularly: Taken routinely even when asymptomatic
5. Able to enter electronic diaries via smartphone or PC
6. Voluntarily consented in writing after receiving sufficient explanation and understanding the study
Key exclusion criteria
1. Currently receiving medication for chronic disease
2. Currently under dietary or exercise therapy supervised by a physician
3. Current or past history of serious illness
4. Taking over-the-counter drugs, quasi-drugs, health foods, supplements, Foods for Specified Health Uses, or Foods with Functional Claims (participation allowed if discontinued after consent and during the study)
5. going outside for more than an hour at a time less than once per week
6. Current or past history of food or drug allergies
7. Habitual excessive alcohol intake (>=40g pure alcohol/day)
8. Habitual excessive smoking (>=21 cigarettes/day)
9. Irregular lifestyle, such as shift or night work
10. Plans to significantly change lifestyle (diet, sleep, exercise) during the study, e.g., long trips
11. Pregnant, breastfeeding, or planning pregnancy during the study
12. Participating in another clinical trial, within four weeks after another trial, or planning to join another trial after consenting to this study
13. Deemed unsuitable for participation by the principal or sub-investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shan |
| Middle name | |
| Last name | Lin |
Organization
Grape King Bio Ltd.
Division name
Biotech Research Institute
Zip code
325002
Address
No.68, Longyuan 1st Rd., Longtan Dist., Taoyuan City 325, Taiwan (R.O.C.)
TEL
+886(3)49930935802
shan.lin@grapeking.com.tw
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Grape King Bio Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.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 | 03 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069493
