Clinical study on therapeutic effects of seasonal allergic rhinitis treatment sheet (HATS-03)
- Conditions
- seasonal allergic rhiniti
- Registration Number
- JPRN-jRCT2032210618
- Lead Sponsor
- Okazaki Narumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 370
(1) Seasonal allergic rhinitis (three main signs of paroxysmal recurrent sneezing, watery rhinorrhea, nasal congestion) for the past two years, and who is taking drug therapy or pollen antigen removal therapy (mask, nasal irrigation) .
(2) Patients with serum-specific IgE antibody (cedar score of 2 or more)
(3) Patients with more than 8 points in total nasal symptom score (sneezing attack score, nasal discharge score, nasal congestion score, nasal pruritus score, i.e. 4TNSS) at the beginning of the period I and with more than 7 at the beginning of the period II by principal- or sub- investigators.
(4) Patients who can stop drug therapy or concomitant therapy for the treatment of allergic rhinitis after obtaining consent.
(5) Patients who have opportunities to go out on a daily basis.
(6) Patients who can enter subjective symotoms into e-PRO by themselves
(7) Persons aged 20 to 65 at the time of consent acquisition.
(8) Participants who can receive explanations of the study in advance, understand the contents, and obtain the written consent of the subject oneself.
(1) Perennial allergic rhinitis patients who have nasal discharge or nasal congestion throughout the year
(2) Patients with bronchial asthma within 2 years before obtaining consent
(3) Patients who meet the following within one year before the start of the treatment period
1) Allergen immunotherapy (subcutaneous, sublingual) for the treatment of hay fever. Provided that ; those who used steroid collunarium during ceder pollinosis season (January to May) are excluded.
2) Allergen immunotherapy (subcutaneous, sublingual) for the treatment of hay fever.
3) Patients who have undergone surgery (including laser treatment) on the nose
(4) Patients with inflammation of the upper or lower respiratory tract, nasal diseases (nasal mushrooms, nasal septum curvature, hypertrophic rhinitis) affecting the efficacy at the beginning of the period I and at the beginning of the period II or Person who used immunological suppressor
(5) A person who has a skin disease or a wound on the site (nose, cheek, lips, chin) where the test device and the device holder
(6) Persons who have a predisposition to metal (silver, titanium) allergy
(7) Participants in other clinical trials within 12 weeks before obtaining consent
(8) Participants in other clinical trials within 12 weeks before obtaining consent
(9) Pregnant and possibly pregnant (pre-menopausal women confirmed by pregnancy test), patients wishing to become pregnant or nursing during the study period
(10) Any other person judged by the investigator or investigator to be inappropriate for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method