asal spray with licorice extract to treat inflammation of the nose and sinuses

Phase 2

• Conditions: Treatment of patients with allergic rhinitis; Respiratory

• Registration Number: ISRCTN13188211
• Lead Sponsor: Chiayi Chang Gung Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-01
• Last Update Posted: 12 September 2022
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients with allergic rhinitis; the diagnostic criteria require a visual analogue scale (0-100) in the four categories of sneezing, itchy nose, rhinorrhea and nasal obstruction with a summed score greater than 120, and immunoglobulin E greater than 120 kU/L, and more than one inhalation allergen, such as dust.

Exclusion Criteria

1. Patients aged less than 20 years
2. A history of allergy to licorice or corticosteroid
3. Pregnancy
4. A history of malignancies of the sinuses or nasopharynx
5. Patients who had undergone turbinate, septum or sinus surgery
6. If steroids or antihistamines is used in the month prior to inclusion, one month of cessation is required to conduct the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The four main symptoms of allergic rhinitis (sneezing, itchy nose, rhinorrhea, and nasal obstruction) are evaluated using a visual analogue scale (0-100) before treatment, at two weeks and four weeks. In addition, SNOT-22 is also used to evaluate 22 allergic rhinitis-related symptoms in patients, and the scores are summed to compare the improvement of the total score before treatment and at two and four weeks.

Secondary Outcome Measures

Name	Time	Method
We used acoustic rhinometry to assess the improvement in nasal resistance before and after treatment, record and compare the improvement of the inferior turbinate hypertrophy before and after treatment with endoscopy, and collect nasal secretions to investigate the changes of intranasal microenvironment before and after treatment were analyzed and compared. All three measurements are assessed before treatment and at two and four weeks of treatment.