Actively Recruiting

Phase Not Applicable
Age: 6Years - 65Years
All Genders
ID05348148

Comparison of Effects for Lightening Shiners Among Different Treatments for Rhinitis in Children, Adolescents, and Adults

Led by Camillians Saint Mary's Hospital Luodong · Updated on 2022-04-27

450

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying children, adolescents, and adults aged 6 to 65 years old who have moderate to severe allergic or non-allergic rhinitis to understand how different treatments affect the dark circles under the eyes known as shiners. These shiners are caused by fluid buildup due to nasal congestion common in rhinitis. The study aims to determine if treatments can reduce shiners and which treatment is most effective. Participants are randomly assigned to one of three treatment groups. One group receives oral antihistamine (Levocetirizine) alone. The second group receives a combination of intranasal corticosteroids (Mometasone Furoate) with oral Levocetirizine. The third group receives the same combination plus a one-week course of intranasal decongestant (Oxymetazoline). Digital images and questionnaires about quality of life related to rhinitis are collected before and after treatment at 1, 2, and 4 weeks. Throughout the study, researchers take standardized photos of the shiners and analyze their darkness and area using digital tools. Participants complete quality of life questionnaires appropriate for their age group. Data on patient history and medications are also collected. The main outcomes measured are changes in the darkness and size of the shiners at 1, 2, and 4 weeks after treatment. The study monitors how these changes relate to the effectiveness of the treatments for rhinitis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of moderate to severe rhinitis, either allergic rhinitis or non-allergic rhinitis
Not Eligible

You will not qualify if you...

  • Chronic rhinosinusitis
  • Trauma to the forehead or nose
  • Face surgery
  • Malignancy
  • Pregnancy
  • Respiratory tract infections within a week before beginning the study
  • Usage of medications for rhinitis within a week before beginning the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants are randomly assigned to one of three treatment groups using different combinations of oral and intranasal medications for rhinitis. They receive treatments including oral antihistamine only, combined intranasal corticosteroids with oral antihistamine, or combined intranasal corticosteroids with oral antihistamine plus a one-week intranasal decongestant. Digital images and questionnaires are collected to evaluate the effects on shiners.

1 baseline visit and 3 follow-up visits on Days 7, 14, and 28

Trial Site Locations

Total: 1 location

1

Camillian Saint Mary's Hospital Luodong

Luodong, Yilan, Taiwan, 26546

Actively Recruiting

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Research Team

C

Cheng-Tsung Yang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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