Clinical Trial: Effects of daily consumption of dried finely powdered asparagus on the reduction of eye and nasal discomfort for 8 weeks: A randomized, double-blind, placebo-controlled parallel-group comparison study (Japan)

Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059055) titled 'Effects of daily consumption of dried finely powdered asparagus on the reduction of eye and nasal discomfort for 8 weeks: A randomized, double-blind, placebo-controlled parallel-group comparison study' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - University of Miyazaki

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of daily consumption of dried finely powdered asparagus on the reduction of eye and nasal discomfort in healthy subjects who regularly experience nasal and eye discomfort of a certain severity but are not receiving any drug treatment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Subjects take 10g dried finely powdered asparagus per day for 8 weeks. Interventions/Control_2 - Subjects take 10g placebo food per day for 8 weeks.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who have regular nasal or ocular discomfort of a certain severity (responded with any of the symptoms in "I. Nasal and Ocular Symptoms" on the JRQLQ No. 1 and with a total score of 5 or higher) and who do not regularly use medicines for symptom relief. 3. Subjects who have no clinical abnormality by screening tests. 4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study. Key exclusion criteria - 1.Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular, dermatological, and/or mental disease, or who have history of those disease. 2.Subjects who have a serious injury or surgical history within 12weeks prior to this study. 3.Pre-or post-menopausal women having obvious changes in physical condition. 4. Subjects who unable to ingest asparagus. 5.Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 6. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence. 7.Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 8.Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study or subjects who plan to donate blood during this study. 9. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study. 10.Subjects who have cognitive disorder or who have possibility of the disorder. 11.Subjects who participate and take the study drug in other clinical trials within four weeks prior to this study. 12.Subjects who are judged as unsuitable for this study by the principal investigator or sub investigators. Target Size - 40

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 08 Month 21 Day Date of IRB - 2025 Year 09 Month 24 Day Anticipated trial start date - 2025 Year 09 Month 30 Day Last follow-up date - 2026 Year 03 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067544

Disclaimer: Curated by HT Syndication.