Tokyo, March 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060796) titled 'A Clinical Study Evaluating Cordyceps cicadae Mycelium Supplementation for Ocular and Nasal Discomfort - A Randomized, Double-Blind, Placebo-controlled Parallel-Group Trial -' on March 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 20
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 Size - 60
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069493
Disclaimer: Curated by HT Syndication.
