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临床试验/CTRI/2021/12/038922
CTRI/2021/12/038922尚未招募3 期

A Comparative Clinical Study of Shatyadi Churna and Shunthi Pushkaramooladi Churna on Tamaka Shwasa (Bronchial Asthma) in Children

ITRA1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Changes in the laboratory investigations for eg Hb TLC DLC ESR and AEC

研究概览

简要总结

This is an open labelled randomized comparative clinical trial to Compare the efficacy of Shatyadi Churna and  Shunti Pushkarmooladi Churna on Tamaka Shwasa in Children, in which the medicine will be given through the oral route.There are two groups for the study purpose: Group A - Shatyadi Churna and in Group B - Shunti Pushkarmooladi Churna with 10 participants in each group with a duration of 8 weeks (56 days) with anupana as Honey. Follow up period for this study is 4 weeks for both the groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
5.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of bronchial asthma Patients having signs and symptoms of Tamaka Shwasa.

排除标准

  • Children of either sex belonging to age ground below 5 years and above 16yrs Evidence of requirement for intubation or had been hospitalized within or before 1 month unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 4 weeks Patients suffering from systemic illness such as TB HIV and other chronic debilitating disease Evidence of active pulmonary disease other than asthma Patients using any oral corticosteroids Astemizole Nedocromil Cromolyn and Long acting B agonist Ketotifen or Theophylline.

结局指标

主要结局

Changes in the laboratory investigations for eg Hb TLC DLC ESR and AEC

时间窗: after 8 weeks

Improvement in peak flow meter and spirometry parameter

时间窗: after 8 weeks

Less frequency of Asthma attack and relief in dyspnea

时间窗: after 8 weeks

次要结局

  • Improvement in clinical signs and symptoms of Tamaka Shwasa for eg Ghurghurakam Kricchrashaknoti bhasitum Kasa(Day 0 and Day 56)

研究者

发起方
ITRA
申办方类型
Research institution and hospital

研究点 (1)

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