A Clinical Study of Waram-e-Tajaweef-e-Anf Muzmin†(Chronic Rhinosinusitis) and the Comparative Evaluation of Sharbat-e-Banafsha and Joshandha Gaozaban in its Management
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1 reduction in AAO-HNS criteria
研究概览
简要总结
The term sinusitis is replaced by rhinosinusitis because sinusitis is often preceded by rhinitis and rarely occurs without concurrent nasal airway inflammation. Thus, the refers to inflammation of the mucosal lining of nose and paranasal sinuses. Chronic rhinosinusitis is very common condition and has been estimated to affect approximately 5-15% of general population. It is often very frustrating and difficult to treat therefore many patients have undergone with repeated courses of antibiotics, long term use of oral or topical steroids and multiple sinus surgeries increasing their risk of colonization with antibiotic resistant agent, various side effects of steroids and of surgical complications. Approximately 200000 U.S adult undergo sinus surgery per year for chronic rhinosinusitis, most commonly because of failing medical therapy. As far as economic impact is concerned, CRS accounts for substantial healthcare expenditure in terms of doctor’s visits, antibiotic prescribed, lost work days and missed school days. In unani literature there is no specific description of *Waram-e-Tajaweef-e-*Anf Muzmin (chronic rhinosinusitis) but the features described byunani physicians under nazla barid and nazla muzmin in various books corresponds with signs and symptoms of sinusitis.
Unani system of medicine provides abundance of single and compound drugs which can be given in nazla barid for longer duration without any known side effect.
The goal of the research work is to provide economical, effective and consecutive management of chronic rhinosinusitis and to protect the patient from known side effects of modern medicine. Moreover, to achieve and maintain clinical control, avoid complications and to minimize the surgical requirement by using two different Unani formulations Sharbat-e-Banafsha and Joshandha Gaozaban (**Gaozaban Gul-e-gaozaban, Asl-us-soos Qand safed), two separate groups and also to compare their effects on relieving the symptoms of chronic rhinosinusitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients fulfilling AAO-HNS criteria that is at least two major criteria (Nasal obstruction or blockage, anterior or posterior nasal discharge, Facial pain /congestion, Purulence in a nasal cavity on examination, Anosmia/ Hyposmia) or one major and two minor criteria (Halitosis, earache, dental pain, cough, fatigue) 2 patients had an opacity of X-ray paranasal sinuses (waters view) ranging from +1 (Mucosal thickening) to +3 (complete opaque antrum) grading.
- •3 Patients of either sex.
- •4 Patients in the age group of 18 to 60 years.
- •5 Patients with involvement of any sinus.
- •6 Those who give written consent.
排除标准
- •1 Child below 18 years of age.
- •2 Patients above 60 years of age.
- •3 Pregnant & lactating mothers.
- •4 Patients who fail to give consent.
- •6 Mentally retarded persons.
- •7 Patients with Malignancy of the nose or paranasal sinuses.
- •8 Patients have a history of any surgery of the nose or paranasal sinuses.
- •3Patient have a history of trauma to the nose or sinus areas.
- •10 Patients suffering from any congenital or acquired structural abnormality of the nasal cavity.
- •11 Any medical condition where the physician feels that participation in the study could be detrimental to patientsÂ’ wellbeing.
- •12 Patients of pulmonary Kochs or patients having history of epistaxis.
结局指标
主要结局
1 reduction in AAO-HNS criteria
时间窗: 0 and 6 week
2 reduction in X-ray paranasal sinuses (waters view) ranging from +1 (Mucosal thickening) to +3 (complete opaque antrum) grading.
时间窗: 0 and 6 week
次要结局
- improvement in clinical features(0 and 6 week)