To evaluate the medical device Wellrhino's relief effect of allergic rhinitis symptoms with single center, double blind, randomized, parallel design(contrast with Sham device) safety and efficacy pivotal study on allergic rhinitis patients with moderate allergic rhinitis (Total Nasal Symptom Score 0~9)

Optowell0 个研究点目标入组 50 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Patients with allergic rhinitis (rhinorrhea, sneezing and nasal itching) who were allergic to the allergen within 12 months
•2. Patients with total nasal Symptom score (TNSS) of 0 to 9 on the screening visit date
•3. Aged = 19 years
•4. Those who have no problem in expressing their opinions
•5. Voluntary written consent to the subject consent form.

•1. Patients who are expected to be inadmissible for the use of concomitant medication prescribed in the protocol
•2. Person who received laser treatment for allergic rhinitis within the last 14 days
•3. A person who has a serious disease such as malignant tumor, anemia, active pulmonary tuberculosis, infection or systemic disease
•4. A person with anatomical obstruction or deformation in the nasal cavity or surgical history (within the last 6 months)
•5. A person with active respiratory disease such as asthma
•6. A person with hypertension or diabetes
•7. A person who have received immunotherapy or systemic adrenal cortical hormone treatment within the last 6 months
•8. A person who is sensitive to laser light or is taking medications
•9. A person who have a wound on the irradiated area
•10. Women who are pregnant or breast-feeding or are likely to become pregnant
•11. A person who have participated in other clinical trials within the past month
•12. A person who judged by other investigator to be unable to perform clinical trials properly

发起方

Optowell