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临床试验/CTRI/2022/06/043567
CTRI/2022/06/043567已完成2 期

An open non randomized single arm single centric clinical trial to determine the effectiveness of Swasakudori Mathirai in the management of Sooli Kanam(childhood asthma) in children.

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月7日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Effectiveness of the trial drug is measured by peak expiratory flow meter.

研究概览

简要总结

INTRODUCTION: This is an open non randomized clinical trail to determine the effectiveness of siddha herbal formulation Swasakudori Mathirai.  Sooli Kanam has been described in the siddha literatures as the diseases frequently occuring in children . According to siddha texts, It is characterized  by prolonged expiration and expiratory wheeze,  prolonged cough, abdominal bloating and discomfort du to mouth breathing. It canbe closely compared with childhood Asthma. Asthma is a chronic inflammatory disease characterized by airwayobstruction, airway hyper responsiveness manifest as wheeze, cough, shortness ofbreath and chest tightness. .Asthma tends to affect about 10% childrenglobally. Recent data have shown that asthma continues to affect 6 millionschool aged children with approximately half of these children experiencing asthma attackeach year. MATERIALS AND METHODS: A total of 30 patients within age limit of 3-12 years willing to participate in the study by signing consent and assent form will be enrolled in the study. Both male and female children are included. RESULTS AND  DISCUSSIONS: Effectiveness of the trial drugis measured by peak expiratory flowmeter. Reduction of clinicalsymptoms by using PASS SCORE. And the results will be statistically analysed.

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
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • children with minimum 3-4 clinical symptoms of bronchial asthma may be included, 1.Cough 2.Wheezing 3.Tightness of chest 4.Abdominal bloating, shortness of breath.
  • 5.Peak expiratory flow rate more than 50%(mild, moderate exacerbation).

排除标准

  • 1.Peak expiratory flow rate less than 50%(severe exacerbation) 2.Congenital heart diseases 3.Pneumonia 4.H/o pulmonary tuberculosis 5.Any other serious illness.

结局指标

主要结局

Effectiveness of the trial drug is measured by peak expiratory flow meter.

时间窗: Screening - 3 months | Patient Enrolment - 3 months | Trial Drug - 4 months | Data Analysis - 1 month | Follow up - 1 month

PRIMARY OUTCOME:

时间窗: Screening - 3 months | Patient Enrolment - 3 months | Trial Drug - 4 months | Data Analysis - 1 month | Follow up - 1 month

次要结局

  • Reduction of clinical symptoms by using PASS SCORE.

研究者

申办方类型
Research institution and hospital

研究点 (1)

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