To Evaluate the Efficacy of Sharbat-e-Ustukhuddus in the management of Waram Tajawif al-Anf Muzmin (Chronic Rhinosinusitis): An open label interventional clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analog Scale(VAS)
研究概览
简要总结
Chronic Rhinosinusitis) is defined as a group of disorders characterized by inflammation of paranasal mucosa and it is due to various aetiologies. Since inflammation of sinuses nearly always involves the nasal mucosa. Rhinosinusitis is now generally preferred term for this condition. Rhinosinusitis is a significant health problem which seems to the mirror the increasing frequency of allergic rhinitis and is an umbrella covering multiple disease entities, including acute Sinusitis, chronic Sinusitis with nasal polyps and chronic Sinusitis without polyps.
Chronic Rhinosinusitis affects approximately 15% of the general population .The National Institute of Allergy and Infectious Diseases (NIAID) estimates 134 million Indians suffer from Chronic rhinosinusitis. Among Indians the disease is more widespread than diabetes, asthma or coronary artery disease. which results in a large financial burden on society. It is one of the most common reason for an individual seeking medical care.
Medical management of Chronic Rhinosinusitis often require combining multiple medications including antibiotics, nasal decongestant, topical nasal steroid or oral steroids and saline irrigation.
There are several single as well as compound Unani drugs which are in use for centuries for effectively treating Chronic Rhinosinusitis but many of them have not been evaluated clinically on scientific parameters further, the limitations of management of Chronic Rhinosinusitis available in modern medicine necessitate a scientific search for safe, effective and convenient medications for the disease.
Keeping this in view, the present study is designed to evaluate the efficacy of Sharbat Ustukhuddus in case of Chronic Rhinosinusitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Mild to Moderate case of Chronic Rhinosinusitis 2 Duration of the disease More Than 12 weeks 3 Patient having at least two out of four cardinal symptom (facial pain/pressure, hyposmia or anosmia, nasal obstruction, and nasal discharge for at least 12 consecutive weeks 4 Patient having any of the following symptoms like rhinorrhea, nasal congestion, frontal headache, nasal itching, impaired sense of smell and frequent sneezing for more than 12 weeks 5 X-ray PNS with Positive finding (Thickened mucosal lining, opacity of sinus).
排除标准
- •1 Patient aged less than 18years or more than 50years.
- •2 Patient with deviated nasal septum (DNS).
- •3 Local pathology such as mucocele, cyst, Antrochoanal polyp, facial trauma.
- •4 Diabetes mellitus and any other illness requiring long term treatment.
- •5 Pregnant or Lactating Women.
- •6 Significant Pulmonary or Cardiovascular or Hepatorenal Dysfunction.
- •7 Patient not willing to attend regular treatment and follow-up for the entire duration of study.
- •9 Patient having history of trauma to nose or sinus area.
- •10 Patient of pulmonary Koch’s or having history of epistaxis.
- •11 Any medical condition where physician feels that participation in the study could be detrimental to patient’s wellbeing.
结局指标
主要结局
Visual Analog Scale(VAS)
时间窗: 2nd, 4th, and 6th Week from baseline.
SNOT-22:CRSspecificQoL
时间窗: 2nd, 4th, and 6th Week from baseline.
次要结局
- X-RAY (PNS)- Water’s View(AEC(Absolute Eosinophil Count))
研究者
Mohd Salman
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016