A Randomized Open Label Comparative Clinical Study to Evaluate the Efficacy of Pathadi Churna and Mridvikadi Churna in the Management of Tundikeri (Tonsillitis) in Children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- It will be assessed on the basis of statistical analysis applied on subjective parameter Jwara Kasa Kantha Vedna Tundikeri Vriddhi Lasika Granthi Vriddhi Gala Upardha and objective parameter CBC ESR CRP Friedman Grading Scale For Tonsillits after completion of trial
研究概览
简要总结
This randomized open-label comparative clinical study aims to evaluate the efficacy of Pathadi Churna and Mridvikadi Churna in the management of Tundikeri (Tonsillitis) in children. A total of 66 participants (33 in each group) aged 5–15 years will be enrolled using computer-assisted randomization. The intervention involves oral administration of the respective trial drugs as per pediatric dosing, twice daily after meals, for a duration of 14 days. Clinical assessment will be based on both subjective parameters (fever, cough, throat pain, dysphagia, tonsillar swelling) and objective criteria (CBC, ESR, CRP, Friedman grading). The study anticipates significant reduction in clinical symptoms, improved quality of life, and validation of Ayurvedic formulations as safe and effective alternatives in pediatric tonsillitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Parents of children willing to participate in the research trial.
- •Children of age group 05-15 years.
- •Irrespective of Caste, Sex, Religion and socioeconomic status.
- •The patient having classical sign and symptoms of Tundikeri (Tonsillitis) in children.
排除标准
- •Patients with age below 5 year and above 15 years.
- •Children having any systemic disorders like TB, DM, Cardiac and renal problems.
- •Patient having congenital anomalies Children Suffering from Peri-Tonsillar Abscess, Tonsillar Cyst, And Tonsillolith.
结局指标
主要结局
It will be assessed on the basis of statistical analysis applied on subjective parameter Jwara Kasa Kantha Vedna Tundikeri Vriddhi Lasika Granthi Vriddhi Gala Upardha and objective parameter CBC ESR CRP Friedman Grading Scale For Tonsillits after completion of trial
时间窗: 14 days
次要结局
- Improvement in quality of life in children(14th day 21th day 28th day)
研究者
Dr Vishal Kashinath Kashte
Institute for Ayurved Studies and Research Former Shri Krishna Govt. Ayurvedic College