A Preclinical and double-arm clinical Study to evaluate the Therapeutic efficacy of PEICHORI KUDINEER (Internal) and SAINTHAVAATHI LEBANAM (External) in the Management of SEETHA PITHAM(URTICARIA) in the Paediatric age group.
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
研究概览
简要总结
BACKGROUND:
This study is planned as a preclinical and double-arm clinical study to evaluate the therapeutic efficacy and safety of Peichori Kudineer (internal) and Sainthavaathi Lebanam (external) in the management of Seetha Pitham (urticaria) in children. The preclinical phase will assess the safety profile of the study drugs, while the clinical phase will include paediatric patients diagnosed with Seetha Pitham. Efficacy will be evaluated based on improvement in urticarial symptoms such as wheals, pruritus, duration, and recurrence, along with safety assessment through clinical monitoring. The study aims to generate scientific evidence for the use of Siddha internal and external medicines in paediatric urticaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Urticaria symptoms like wheals,redness,pruritus, Allergic reactions which includes Foods,vegetable spices,and fruits Medications plants Food preservatives Industrial materials physical stimuli Insect bite/stings.
排除标准
- •Children below 2 years and above 12 years Auto immune cause Mastocytosis Stills disease Atopic dermatitis Infection induced urticaria Erythema multiforme.
研究者
Dr Y S SHILPAASHRI
Government Siddha Medical College and Hospital,Palayamkottai