CTRI/2021/01/030216已完成2 期
Clinical evaluation of the effect on oral administration of VILVA ENNAI for the treatment of VALI KANAM.
Dr K Ragavi Sayi Saranya1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年5月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Decreases the body temperature, cough, vomitting, constipation and other clinical symptoms.
研究概览
简要总结
The study is a single arm clinical trial to evaluate the therapeutic efficacy of VILVA ENNAI for the treatment of VALI KANAM. The trial drug will be administered orally at the dose of 4 ml before the food once a day at morning for a period of 10 days in 56 patients. The trial period of 24 months will be carrying out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu.
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
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •subjects with any of the following symptoms will be included in the study
- •Fever associated with Respiratory symptoms, Urinary tract symptoms and Gastrointestinal symptoms
- •Loss of appetite
- •Vomitting
- •Decreased urine output
- •Dryness of mouth
- •Constipation.
排除标准
- •Children below 3 years and above 12 years
- •Fever due to malignancy, trauma, psychological factors
- •High grade fever
- •Cough with hemoptysis
- •Fever associated with other complications such as HIV, meningitis, Tuberculosis
- •Cardiac diseases
- •Chronic Renal diseases
- •Severe Dehydration.
结局指标
主要结局
Decreases the body temperature, cough, vomitting, constipation and other clinical symptoms.
时间窗: 10 days
次要结局
未报告次要终点
研究者
研究点 (1)
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