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临床试验/CTRI/2024/06/069090
CTRI/2024/06/069090尚未招募2 期

An pilot study to assess the effectiveness of Bringaraja thailam for the management of childhood bronchial asthma

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
10
试验地点
1
主要终点
Effectiveness of the trial drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline

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 Bringaraja thailam. 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 due to mouth breathing. It can be closely compared withchildhood Asthma. Asthma is a chronic inflammatory disease characterized by airway obstruction, airway hyper responsiveness manifest as wheeze, cough, shortness of breath and chest tightness. .Asthma tends to affect about 10% children globally. Recent data have shown that asthma continues to affect 6 million school aged children with approximately half of these children experiencing asthma attack each year. MATERIALS AND METHODS: A total of 10 patients within age limit of 6 to 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 drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline and also assess  the  improvement in the symptoms by GINA Global Initiative for Asthma Guidelines 2022 and St. Georges respiratory questionnaire.

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

入选标准

  • 1 Children of both sex in the age group of 6 to 12 years 2 Is diagnosed with asthma by following the Global Initiative for Asthma (GINA) guidelines and St Georges respiratory questionnaire 3 Children having FEV1 greater than 60 percentage TO less than 80 percentage 4 Patient willing to co-operate for spirometry test 5 Parent willing to sign the informed consent form.

排除标准

  • 1 H/O Pulmonary tuberculosis 2 H/O Bronchiectasis 3 Subject unable to do Spirometry 4 Any other serious illness.

结局指标

主要结局

Effectiveness of the trial drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline

时间窗: Effectiveness of the trial drug will be assessed by spirometry before and after treatment

次要结局

  • Improvement in the symptoms assessed by GINA Global Initiative for Asthma Guidelines 2022 and St Georges Respiratory questionnaire

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Karthika Prakasan

Research and hospital, National institute of siddha

研究点 (1)

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