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临床试验/NCT07063082
NCT07063082尚未招募不适用

Efficacy Of Erythromycin Phonophoresis on Chronic Rhinosinusitis

Cairo University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Sinusitis symptom score (SSS)

研究概览

简要总结

The purpose of the study is to evaluate the therapeutic effect of erythromycin phonophoresis in reducing chronic rhinosinusitis.

详细描述

Chronic rhinosinusitis (CRS) is defined as "inflammation of the nose and the paranasal sinuses characterized by two or more symptoms, one of which should be either nasal blockage, obstruction, congestion or nasal discharge (anterior or posterior nasal drip) with/without facial pain or pressure, reduction or loss of smell, endoscopic signs of nasal polyps, mucopurulent discharge primarily from middle meatus, oedema, mucosal obstruction primarily in middle meatus and computed tomography (CT) changes (mucosal changes within the osteomata complex and/or sinuses)".

CRS may be a benign disorder, but it has significant morbidity. If not treated, the quality of life is poor. The condition is known to exacerbate asthma and can even lead to meningitis and brain abscess formation- which increases morbidity and mortality. Patients with chronic sinusitis who are treated usually have satisfactory outcomes. Symptom relief can be obtained after functional endoscopic sinus surgery in about 75% of patients who fail to respond to medical management. In rare cases, chronic sinusitis can result in orbital and intracranial infections, leading to visual and neurological deficits.

This study will design to provide a guideline about effect of erythromycin phonophoresis on chronic rhinosinusitis and to assist in planning ideal treatment program.

The treatment for chronic rhinosinusitis is realized through the use of medications such as corticosteroids, antibiotics and antimycotics or surgical procedures. However, treatments are not always effective, which makes patients adhere to other therapeutic modalities, including medicinal herbs, homeopathy and probiotics. A modality that stands out is the use of therapeutic ultrasound, which has shown promising results for its anti-inflammatory and antinociceptive activity.

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
None

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range between 25-50 years.
  • Male and female patients will participate in the study.
  • All patients have chronic rhinosinusitis.
  • All patients enrolled in the study will have their informed consent.
  • CT will include at least affection of maxillary sinus.

排除标准

  • Patients with pacemaker
  • Patients diagnosed with cancer.
  • Pregnant women
  • Patients with impaired vascular circulation
  • Patients who suffer from mental or psychological disorders.
  • Patients with any systemic diseases that may interfere with the objectives of the study.
  • Congenital defects on face and nose.
  • Fracture of nose or face.
  • Polypoidal patients.
  • Allergic patients.
  • Previous nasal surgery.

研究组 & 干预措施

Ultrasound + Topical Erythromycin + Medical treatment

Active Comparator

This group will include 30 patients with chronic rhinosinusitis who will receive ultrasound followed by topical use of Erythromycin gel on nose 12 session , 3 days per week and medical treatment (saline nasal wash) 3 times daily for a month.

干预措施: Medical treatment (Other)

Medical treatment

Other

This group includes 30 patients with chronic rhinosinusitis who will receive their medical treatment (saline nasal wash) 3 times daily for a month

干预措施: Medical treatment (Other)

Erythromycin Phonophoresis + Medical treatment

Experimental

This group will include 30 patients with chronic rhinosinusitis who will receive Erythromycin phonophoresis 12 session, 3 days per week, and medical treatment (saline nasal wash) 3 times daily for a month.

干预措施: Erythromycin Phonophoresis (Other)

Erythromycin Phonophoresis + Medical treatment

Experimental

This group will include 30 patients with chronic rhinosinusitis who will receive Erythromycin phonophoresis 12 session, 3 days per week, and medical treatment (saline nasal wash) 3 times daily for a month.

干预措施: Medical treatment (Other)

Ultrasound + Topical Erythromycin + Medical treatment

Active Comparator

This group will include 30 patients with chronic rhinosinusitis who will receive ultrasound followed by topical use of Erythromycin gel on nose 12 session , 3 days per week and medical treatment (saline nasal wash) 3 times daily for a month.

干预措施: Ultrasound (US) (Device)

Ultrasound + Topical Erythromycin + Medical treatment

Active Comparator

This group will include 30 patients with chronic rhinosinusitis who will receive ultrasound followed by topical use of Erythromycin gel on nose 12 session , 3 days per week and medical treatment (saline nasal wash) 3 times daily for a month.

干预措施: Topical Erythromycin (Drug)

结局指标

主要结局

Sinusitis symptom score (SSS)

时间窗: one month

Sinusitis Symptom Scores will be based on a visual analogue scale (VAS) well established. In this method, the six symptoms will be assessed using a scale of 0±10, where zero represents no symptom and 10 represents the most severe symptom imaginable

次要结局

  • Computerized tomography scan (CTS)(one month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

nahla mahmoud mohamed elkassas

Principal Investigator

Cairo University

研究点 (1)

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