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临床试验/CTRI/2024/12/078194
CTRI/2024/12/078194招募中1 期

Effectiveness of nasal rehabilitation on nasal symptoms in patients with chronic allergic rhinitis: A randomized control trial

Manipal Academy of Higher Education1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年12月25日最近更新:

试验速览

阶段
1 期
状态
招募中
入组人数
120
试验地点
1
主要终点
Total nasal symptoms score

研究概览

简要总结

Allergic rhinitis and its impact on asthma [ARIA] define Allergic Rhinitis [AR]as“Type 1 hypersensitive inflammation of the nasal mucosa Induced by exposure to allergic substance.  With at least two or four cardinal nasal symptoms namely sneezing, rhinorrhoea, nasal itching and nasal block present>1 hour/day on most/many days in a year”[1]. The global prevalence of AR is found to be 5% to 50% . In India the prevalence is said to be approximately 22% in adolescents[3].

The early response to the exposure to the allergens causes sneezing, rhinorrhoea, inflammation of mucosal glands and nasal congestion which is mediated by the IgE and lasts for 5 to 15 minutes[4]. The late response which lasts for 4 to 6 hours can causes nasal mucosa production, nasal edema and nasal congestion, which is leukotriene mediated[5].   Based on the symptoms AR can be subdivided  as intermittent [acute] and persistent [chronic]. The AR is said to be acute, If the symptoms of AR are seen for less than 4 weeks or less than 4 days per week and lasting more than that is termed as chronic AR[1][4].  the symptoms of the chronic AR  is same as acute rhinitis but,  the mouth breathing pattern , blueish discoloration of lower eyelids[allergic shiners] seen in the patients with the chronic AR[6] .Mouth breathing can cause reduction in oral hydration, mucociliary clearance, local innate immune defence and mucosal homeostasis due to the lack of oscillatory mechanical pressure that happens in nasal breathing [7][8].There will be reduction in intraoral space which can cause obstruct the pharyngeal airway , nasal muscle dysfunction in mouth breathing[9] .Numerous studies have proven the adverse effect of mouth breathing[10][11][12] . Additionally, some research suggests that improving oral breathing problems does not always result from orthodontic treatment that enlarges the nasal cavity[9] .

The diagnosis of the AR is done by skin prick testing, rhinoscopy and allergic specific IgE test[2].  Pharmacological treatment in AR includes intranasal corticosteroids, antihistamines decongestants, leukotriene receptor antagonists and immunotherapy. All these drugs have several side effects and also increase dependency on drugs[3]. Surgical approach in the AR include inferior turbinate reduction, lateralization outfracture, laser vaporization, radiofrequency abalation and cobalation, sub mucosal resection, septoplasty and endoscopic sinus surgery[14]. Non pharmacological approach include nasal rehabilitation, which could be an alternative measure. There is lack of literature in  the study to evaluate both mouth breathing and nasal symptoms in patients with chronic allergic rhinitis existing literature lack assessment of mouth breathing in patients with chronic allergic rhinitis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with chronic allergic rhinitis by pulmonologist.

排除标准

  • Severe seasonal allergic rhinitis, craniofascial disorder, tracheostomy dependence, prior history of laryngeal, subglottic or pulmonary airway stenosis or surgery, severe psychological problems, other lower respiratory tract disorders, smokers.

结局指标

主要结局

Total nasal symptoms score

时间窗: Baseline and every week for five weeks

次要结局

  • Nasal obstruction symptom evaluation score(Baseline and after five weeks)
  • Rhinoconjunctivitis quality of life questionnaire(Baseline and after five weeks)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sachin Tendulkar

Manipal College of Health Professions, Manipal Academy of Higher Education

研究点 (1)

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