Camillian Saint Mary's Hospital Luodong
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- alleviating darkness of shiners
研究概览
简要总结
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
详细描述
Background:
Shiners results from the accumulation of body fluid in the infraorbital groove. The physiology and pathology in children include nasal congestion, inflammation of nose and eyes, trauma to the nose or the forehead, facial surgery, or facial cancer. In patient with either allergic rhinitis or non-allergic rhinitis, nasal congestion arouses venous stasis, leading to the blue-gray to purple discoloration under the bilateral lower eyelids, called shiners. In patients with allergic rhinitis, allergic shiners, termed by Marks since 1954, have been regarded as a significant sign of allergic rhinitis generally.
In 2009, Chiang and members established a digital-analyzed tool to quantify allergic shiners, and the results demonstrated the darkness and the area values of allergic shiners correlate with the severity of allergic rhinitis.
A stepwise approach for the treatment of allergic rhinitis and non-allergic rhinitis is documented, including oral antihistamine, intranasal antihistamine, intranasal corticosteroids, intranasal decongestant, oral or intranasal leukotriene antagonist, as well as nasal irrigation, but the response of shiners after treatment, and the efficiency of the therapies to alleviate the shiners were unknown. In this study, the primary outcome is to answer whether the levels of shiners can be alleviated by using nasal therapies in patients with allergic rhinitis or non-allergic rhinitis. And the secondary outcome is to figure out which nasal therapies work most effectively.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The independent researchers will carry out the digital image analyze.
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of moderate to severe rhinitis, either allergic rhinitis or non-allergic rhinitis.
排除标准
- •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
研究组 & 干预措施
Oral Levocetirizine
Patients in Levocetirizine group will use oral antihistamine (Levocetirizine) only
干预措施: Oral Levocetirizine (Drug)
Combined Intranasal Mometasone Furoate with oral Levocetirizine
Patients in combined Intranasal Mometasone Furoate with oral Levocetirizineintranasal group will use combined intranasal corticosteroids (intranasal Mometasone Furoate) with oral antihistamine (Levocetirizine)
干预措施: Combined Intranasal Mometasone Furoate with oral Levocetirizine (Drug)
Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline
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)
干预措施: Combined Intranasal Mometasone Furoate with oral Levocetirizine plus intranasal Oxymetazoline (Drug)
结局指标
主要结局
alleviating darkness of shiners
时间窗: Change from baseline darkness of shiners at 4 weeks after treatment.
Change from baseline of the darkness of shiners at 4 week after treatment.
alleviating area value of shiners
时间窗: Change from baseline area value of shiners at 4 week after treatment.
Change from baseline of the area value of shiners at 4 week after treatment.
次要结局
- alleviating area value of shiners among groups(Change from baseline area value of shiners at 4 week after treatment.)
- alleviating darkness of shiners among groups(Change from baseline darkness of shiners at 4 week after treatment.)