Evaluation of Clinical efficacy of Uraimathirai as Immunomodulator
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
- Reduction in Recurrence of Resp Infections
研究概览
简要总结
Urai mathirai is a Siddha formulation found in Hospital pharmacopoeia of Govt siddha medical college Palayamkottai and in use for the past 3 decades. It is observed in Pediatric general practice that Children nursed with Uraimathirai are free from repeated respiratory infection and Uraimathirai is claimed to have Immuno modulating properties. However this Claim is left untested and this PhD study will help to establish the efficacy of the drug comparing with Traditional Siddha formulation Thaleesathy Chooranam 1 gm Bid and Uraimathirai 50 mg daily for continuously for Six months.Before entering into Clinical study Preclinical studies are being carried out to establish the safety and standard of the Drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of either gender aged 6 MONTHS to 6 Years with a history of recurrent URTIs and presenting with URTI at hospital treatment.
- •Â The definition used for recurrent URTIs was three or more such episodes during the last 12 months.
- •Â The current episode required for study eligibility was Defined by the presence of at least two of the following Rhinitis Pharyngitis cough hoarseness, Temperature More than 38.5°C, Prescription of an antibiotic for a URTI, occurring after an asymptomatic Period of at least 1 week without antibiotics.
排除标准
- •occurrence of otitis media and/or sinusitis and/or infection of the lower respiratory tract (ie, bronchitis, pneumonia)and/or proven group A streptococcal angina at the enrollment Further main exclusion criteria were allergic asthma, significant systemic disease (eg, hepatic and/or renal disease, malignancy), immune system disorders, suspected Malabsorption, major surgical procedure within 3 months of commencement of the study recent immunosuppressive or immunostimulant therapy, or corticosteroids.
结局指标
主要结局
Reduction in Recurrence of Resp Infections
时间窗: 6 months
Clinical Improvement
时间窗: 6 months
No Antibiotic treatment
时间窗: 6 months
Increase in Anti bodies IgA/IgG
时间窗: 6 months
Decrease in Phagocytosis
时间窗: 6 months
次要结局
- Safety of trial drug(6 months)