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Evaluation of the Efficacy of Harb Powder Intake for Alleviating Nasal Discomfort During Cedar Pollen Dispersal - A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Study

Evaluation of the Efficacy of Harb Powder Intake for Alleviating Nasal Discomfort During Cedar Pollen Dispersal - A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Study - Evaluation of the Efficacy of Harb Powder Intake for Alleviating Nasal Discomfort During Cedar Pollen Dispersal

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056713
Enrollment
60
Registered
2025-01-14
Start date
2025-02-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Participants will consume 12 study food tablets daily with approximately 100 ml of water or lukewarm water every day for 14 weeks after breakfast or in the morning. Participants will consume 12 contro

Sponsors

IMEQRD Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 20 to 65 years (at time of consent) 2. Gender: Japanese males and females 3. BMI less than 30 kg/m^2 4. Individuals with nasal symptoms caused by cedar pollen (sneezing, runny nose, nasal congestion) deemed suitable for participation by the principal investigator 5. Individuals not taking or only occasionally taking allergy medications before and during the study. Occasional users should be less than half of all participants. 6. Individuals able to cooperate with the study food intake for 14 weeks 7. Individuals able to input electronic diaries via smartphone or PC 8. Individuals who have received sufficient explanation about the study's purpose and content, understood it well, voluntarily agreed to participate, and provided written consent 9. Individuals deemed healthy and suitable for the study by the principal investigator

Exclusion criteria

Exclusion criteria: 1. Currently under medical treatment (occasional use permitted) 2. Acute rhinitis, sinusitis, nasal polyps, or deviated nasal septum 3. History of nasal surgery 4. Bronchial asthma 5. Severe liver, kidney, heart, respiratory, endocrine, or metabolic diseases (except appendicitis) 6. Undergoing specific desensitization therapy 7. Regular intake of lactic acid bacteria products (3+ days/week), unless discontinued during the study 8. Regular intake of anti-allergic foods like sweet tea or Benifuuki tea (3+ days/week) unless ceasing during the study 9. Regular intake of foods or supplements claimed to have health benefits unless discontinued during the study 10. Allergic reactions to the study food 11. History of drug or food allergies 12. Excessive alcohol consumption (40g+ pure alcohol/day) 13. Smoking habits (less than 1 year of cessation) 14. Shift work with night shifts 15. Planning significant lifestyle changes during the study 16. Planning travel abroad during the study 17. Pregnant, breastfeeding, or planning pregnancy during the study 18. Participation in another clinical study within 1 month before consent or currently participating or planning to participate during the study 19. History of discomfort or health deterioration from blood sampling 20. Considered unsuitable for the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Nasal Symptom Score of JRQLQ

Secondary

MeasureTime frame
Eye Symptom Score and Quality of Life (QOL) Score of JRQLQ Nasal Cavity Evaluation (inferior turbinate mucosal swelling, color of inferior turbinate mucosa, watery secretion volume, nasal discharge properties) Specific IgE (Cedar, Cypress), Non-specific IgE

Countries

Japan

Contacts

Public ContactHirokuni Kayama

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp0367045968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026