An open label randomized comparative clinical study to evaluate the efficacy of Zasdamrut in Acute Upper Respiratory Tract Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment on the basis of Jackson Downing URTI scale
研究概览
简要总结
Upper respiratory Tract infection (URTIs) is one of the most common diseases among adults, who generally experience infections for two to five times a year. Upper respiratory tract infections such as laryngitis, pharyngitis, nasopharyngitis, and rhinitis, are among the most common diseases in primary medical care. The majority of URTI’s are of viral origin, due to rhinovirus, parainfluenza virus, corona virus, adenovirus, coxsackie virus, and influenza virus. Only 10% of URTI has beenattributed to bacterial etiology. The management of URTI of viral origin involvessymptomatic treatment like antihistamines, antipyretics or anti-inflammatory agents, coughsuppressants, expectorants and decongestants. Antibiotic treatment is beneficial only if symptoms persist for 10-14 days without improvement. Hence it poses a challenge to the clinicians to differentiate between viral and bacterial origin of URTI. In India, several studies have reported that 45% to 86% of URTI cases are treated with antibiotics. This is despite large amounts of evidence on the self-limiting nature of acute URTI. Problems associated with the overuse of antibiotics include development of bacterial resistance, increasing the burden of chronic disease, raising the cost of health services and the development of side effects. Hence there is need of better alternative treatment for the management of URTI. In this study, Zasdamrut tablet will be given to the patients with URTI for 7 days, and assessment will be done on the basis of Jackson Downing scale and on different blood parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
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 of either gender between 18 and 60 years (Both years inclusive) 2 Patients with symptoms on the basis of Jackson Downing URTI scale 3 Those who gives consent and assent as per requirement.
排除标准
- •1 Patients with Chronic bronchial asthma 2 Patients with tuberculosis 3 Patients with severe lower RTI (pneumonia, emphysema, bronchiectasis) or associated with other systemic illness.
结局指标
主要结局
Assessment on the basis of Jackson Downing URTI scale
时间窗: Assessment will be done on day 0, day 3rd or 4th, day 7th and day 14th (without medicine)
次要结局
- Assessment on the basis of CBC, CRP, AEC, MP (Malarial Parasite), Dengue NS-1(Assessment will be done on baseline (day 0) and day 7th)
