An Open Clinical Trial to evaluate the effectiveness of Saruva Thitha Nirgundi Thailam for the treatment of Virana Silethumam (Acute Pharyngo-Tonsillitis) in Children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of the trial drug will be assessed based on reduction in quantitative assessment scales of clinical symptoms.
研究概览
简要总结
There are more number of cases recorded with complaints of fever, dysphagia and enlarged tonsils. So this is the need of the hour to explore a
safe and effective siddha remedy to overcome this disease. The selected experimental drug for this
study SARUVA THITHA NIRGUNDI THAILAM is indicated for Annakku Thooru Thabitham in
the siddha textbook of THERAYAR THAILAVARGA SURUKKAM. The various ingredients of
SARUVA THITHA NIRGUNDI THAILAM possess heat potency to reduce the elevated Kabam, so
that it will be very effective in reducing the symptoms of VIRANA SILETHUMAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with age group of 5 to 12 years of both sex.
- •Enlarged tonsils with Brodsky scale Grade 2 and above.
- •children also having at least three of the following symptoms:
- •Throat pain
- •Difficult to swallow 4.
排除标准
- •Pneumonia
- •Oral candidiasis
- •Tuberculosis
- •Peritonsillar abscess.
结局指标
主要结局
Efficacy of the trial drug will be assessed based on reduction in quantitative assessment scales of clinical symptoms.
时间窗: Baseline at the time of enrolment - 0th day. | First follow up - 7th day. | Second follow up- 14th day. | End point 28th day.
Enlargement of tonsils will be assessed by Brodsky scale.
时间窗: Baseline at the time of enrolment - 0th day. | First follow up - 7th day. | Second follow up- 14th day. | End point 28th day.
Throat pain will be assessed by VAS score.
时间窗: Baseline at the time of enrolment - 0th day. | First follow up - 7th day. | Second follow up- 14th day. | End point 28th day.
Cough severity will be assessed by VAS score.
时间窗: Baseline at the time of enrolment - 0th day. | First follow up - 7th day. | Second follow up- 14th day. | End point 28th day.
Dysphagia will be assessed based on Bazaz dysphagia scale.
时间窗: Baseline at the time of enrolment - 0th day. | First follow up - 7th day. | Second follow up- 14th day. | End point 28th day.
Halitposis will be assessed based on organoleptic score.
时间窗: Baseline at the time of enrolment - 0th day. | First follow up - 7th day. | Second follow up- 14th day. | End point 28th day.
次要结局
未报告次要终点
研究者
Sarathi
National Institute of Siddha