A Clinical Study of the Effects of Unani Formulation (Joshanda) with Reference to the Standard Control in the Management of Iltihab Tajawif al-Anf Muzmin (Chronic Sinusitis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms of Chronic sinusitis (Nazla Barid)
研究概览
简要总结
Sinusitis is inflammation of the sinus or nasal passage . It is classified as acute and chronic sinusitis. Sinusitis is also called Rhinosinusitis . Chronic sinusitis is chronic inflammation of the sinus or nasal passage occurring for more than 12 weeks at a time or ( chronic rhinosinusitis is defined as more than 12 weeks of symptoms without complete resolution of symptoms and can be subdivided into chronic sinusitis with nasal polyp and without nasal polyp. It is a specific clinical symptoms complex. Approximately 20% of the patients with chronic sinusitis have nasal polyposis.Chronic rhinosinusitis affects approx 5-15% of the general population. The prevalence was found to be 2-4%.According to the national health interview survey of 1996 chronic rhinosinusitis was second most prevalent health condition affecting 12.5% of the US population or 31 million patients each year. Affecting individual of all ages.There are no racial differences in prevalence but the presence of nasal polyps’ increases with age and more commonly found in men.Acute viral sinusitis is the most common cause of chronic sinusitis. According to an analysis of the 2008 National Health interview survey data, rhinosinusitis affected 1 in 7 adults.The symptoms of chronic sinusitis include purulent nasal discharge, Constant sinus pressure, chronic cough, halitosis.Since chronic rhinosinusitis is not fatal disease but its outcome is orbital cellulitis, subperiosteal abscess, cavernous sinus thrombosis, brain abscess etc.
In Unani system of medicine sinusitis is not described as such but when we go through the definitions of Nazla wa Zuka**m these seem to be quite similar to the clinical feature of sinusitis. Medical therapy is effective in reducing the symptoms but allopathic medicines do have various side effects. Unani physicians are treating the symptoms of sinusitis for centuries with safe herbal remedies. Need of the hour is to validate these safe drugs scientifically. So, in order to provide safe and effective drug for chronic sinusitis, the present study is therefore designed at investigating the effect of Unani formulation on chronic sinusitis patients.
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
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically diagnosed patients of chronic sinusitis of more than 12 weeks duration.
- •Patients Irrespective of gender.
- •Patients in the age group of 20-60 years.
- •SNOT 22 (Sinonasal Obstruction Test) more than
- •Patients who have agreed to sign the informed consent form and follow up the protocol.
排除标准
- •Subjects below the age of 20 years and above the age of 60 years -Atrophic rhinitis.
- •Deviated Nasal Septum.
- •Nasal polyps / Nasal growth / Adenoids.
- •Patients with systemic diseases like diabetes, cardiovascular, impaired renal and hepatic functions, HIV, T.B., COPD.
- •Patients who refuse to give the written consent for the study.
- •Pregnancy and lactating women.
- •Any of them not covered under inclusive criteria.
结局指标
主要结局
Relief in signs and symptoms of Chronic sinusitis (Nazla Barid)
时间窗: 45 days
次要结局
- Haematological and biochemical assessment for safety(45 days)
