跳至主要内容
临床试验/CTRI/2024/05/067252
CTRI/2024/05/067252尚未招募3 期

An open label non comparative prospective clinical trial on the efficacy of BalRasayana syrup as an immunomodulator and its role in recurrent respiratory tract infections in children

GURUKRUPA AMRUTA AYURVEDA LLP1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年5月20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
32
试验地点
1
主要终点
Improvement in symptoms of respiratory tracrt infections cough cold immunomodulation frequency of cough cold nasal discharge fever

研究概览

简要总结

This study an open label non comparative and prospective trial will be conducted to evaluate the efficacy and safety of Balrasayana syrup doses decided according to age and weight of chilldren in 3 to 16 years  as an immunomodulator and its role in recurrent respiratory tract infections  primary outcome measures will be improvement in symptoms of respiratory tract infections  at 6 weeks the secondary outcome will be improvement in time recovery and hospitalisation during the treatment phase  at 12 weeks

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
3.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed as suffering from Vataja Pratishyaya on Ayurvedic parameters Age group of 3 to 16 years.
  • Cardinal features of recurrent respiratory tract infections History of at least 3 episodes in the last six months.

排除标准

  • Individuals below 3 years and above 16 years Severe and Complicated respiratory allergic disorders like Bronchitis Pneumonia Tuberculosis Emphysema Lung abscess Bronchiectasis Patients who are diagnosed as Chronic asthma Nasal polyposis Congenital anomalies related to the respiratory system Patients on inhaled or systemic steroids Patients who are suspected of any of the diseases mentioned in exclusion criteria on the basis of history and examination will be excluded.

结局指标

主要结局

Improvement in symptoms of respiratory tracrt infections cough cold immunomodulation frequency of cough cold nasal discharge fever

时间窗: 6 weeks

次要结局

  • Improvement in laboratory parameters improvement in hospitalization during treatment phase(12 Weeks)

研究者

发起方
GURUKRUPA AMRUTA AYURVEDA LLP
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Shubhangi Thakur

R A Podar medical college AYU Worli Mumbai

研究点 (1)

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