Comparison of the Effects for Lightening the Shiners Among Different Treatments for Rhinitis

Summary

Background: Shiners are caused when blood and other fluids accumulate in the infraorbital groove. It develops resulting from lots of problems. In patient with rhinitis, either allergic rhinitis or non-allergic rhinitis, shiners are believed to be caused by venous stasis resulting from nasal congestion. This study is aiming that comparison of the effectiveness of treatment of rhinitis (either allergic rhinitis or non-allergic rhinitis) to lighten not only the rhinitis but also the shiners. Randomized control studies.

Design: The investigators will recruit children (6-12 y/0), adolescent (13-18 y/o), or adults (19-65 y/o) with either allergic rhinitis or non-allergic rhinitis, and patients will be randomly assigned to groups (oral antihistamine, combined nasal corticosteroids with oral antihistamine, combined nasal corticosteroids with oral antihistamine plus nasal decongestant, combined nasal corticosteroids with oral antihistamine plus nasal irrigation, combined oral antihistamine with nasal irrigation, or nasal antihistamine only). Digital image will be recorded and analyzed to compare the change of shiners between before and after treatment for rhinitis. The clinical data were collected including patient's data, history, laboratory data, Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Adolescent Rhinoconjunctivitis Quality of Life Questionnaire (AdolRQLQ), or mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), and medications. The primary outcome is to answer whether the levels of shiners can be alleviated by using therapies in patient with rhinitis. And the secondary outcome is to figure out which therapies work most effectively.

Keywords: allergic rhinitis, vasomotor rhinitis, shiners, nasal corticosteroids

Conditions

• Allergic Rhinitis
• Vasomotor Rhinitis

Interventions

DRUG

Oral Levocetirizine

Patients will be randomly assigned into three groups. Patients in oral Levocetirizine group will use oral antihistamine only (Levocetirizine), another in combined Intranasal Mometasone Furoate with oral Levocetirizine group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine), and the other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline). Digital images and the questionnaires, including PRQLQ, AdolRQLQ, and mini-RQLQ, of every participant will be taken at the beginning of the study. Further assessments will be taken at least 3 times, on the seventh day, fourteenth day, and twenty-eighth day after treatment.

DRUG

Combined Intranasal Mometasone Furoate with oral Levocetirizine

Patients will be randomly assigned into three groups. Patients in oral Levocetirizine group will use oral antihistamine only (Levocetirizine), another in combined Intranasal Mometasone Furoate with oral Levocetirizine group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine), and the other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline). Digital images and the questionnaires, including PRQLQ, AdolRQLQ, and mini-RQLQ, of every participant will be taken at the beginning of the study. Further assessments will be taken at least 3 times, on the seventh day, fourteenth day, and twenty-eighth day after treatment.

DRUG

Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline

Patients will be randomly assigned into three groups. Patients in oral Levocetirizine group will use oral antihistamine only (Levocetirizine), another in combined Intranasal Mometasone Furoate with oral Levocetirizine group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine), and the other in combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine) plus one-week intranasal decongestant (intranasal Oxymetazoline). Digital images and the questionnaires, including PRQLQ, AdolRQLQ, and mini-RQLQ, of every participant will be taken at the beginning of the study. Further assessments will be taken at least 3 times, on the seventh day, fourteenth day, and twenty-eighth day after treatment.

Sponsors & Collaborators

• Camillians Saint Mary's Hospital Luodong

  lead OTHER

Principal Investigators

• Cheng-Tsung Yang · Camillian Saint Mary's Hospital Luodong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-16

Primary Completion

2032-03-31

Completion

2032-03-31

Countries

• Taiwan

Study Locations