跳至主要内容
临床试验/CTRI/2024/04/065609
CTRI/2024/04/065609招募中2 期

A single arm clinical study to evaluate the efficacy of Pankajakasthuri Breathe Eazy excel powder in managing various respiratory Disorders

Pankajakasthuri Herbals India Pvt Ltd P1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年4月22日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Any marked change in safety parameters

研究概览

简要总结

Respiratory disorders impose a significant burden on individuals’ health and well-being globally. Herbal formulations have gained attention for their potential in managing such conditions. This single-arm clinical study aimed to evaluate the efficacy of Pankajakasthuri Breathe Eazy Excel Powder in managing various respiratory disorders. A total of 200 participants diagnosed with respiratory disorders, including asthma, chronic bronchitis, and allergic rhinitis, were enrolled in the study. Participants were administered Pankajakasthuri Breathe Eazy Excel Powder according to the recommended dosage for a duration of 6 months. Primary outcomes included improvements in respiratory symptoms, lung function parameters, and quality of life scores, assessed through standardized tools. Secondary outcomes comprised safety profiles and adverse events associated with the intervention. Statistical analyses were conducted to assess the significance of changes observed pre- and post-intervention. The results demonstrated statistically significant improvements in respiratory symptoms, lung function parameters, and quality of life scores following the administration of Pankajakasthuri Breathe Eazy Excel Powder. Moreover, the intervention exhibited a favorable safety profile with minimal adverse events reported. These findings suggest that Pankajakasthuri Breathe Eazy Excel Powder holds promise as an effective and safe adjunctive therapy for managing various respiratory disorders. Further randomized controlled trials with larger sample sizes are warranted to corroborate these findings and establish the clinical utility of this herbal formulation.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age 18 Years and above Patients willing to take Breathe Eazy Excel Powder in a dose of 1 Tea spoon twice daily after food continuously for a minimum period of 3 months.
  • Subjects willing to enroll in study by signing Informed consent.
  • Subjects presenting with Allergic bronchitis, Allergic rhinitis, COPD, Sinusitis, Eosinophilia and other Respiratory tract infections.

排除标准

  • 1 Patients allergic to the any of the ingredients of Breathe Eazy Excel Powder.
  • Pregnant and Lactating mother.

结局指标

主要结局

Any marked change in safety parameters

时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.

measured during the administration of the

时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.

product.

时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.

• Reporting the effectiveness of this product in

时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.

the management of Allergic bronchitis, Allergic

时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.

rhinitis, COPD, Sinusitis, Eosinophilia and other

时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.

Respiratory tract infections and associated

时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.

complaints.

时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.

次要结局

  • Additional therapeutic advantages of the product(0th-baseline1st-first time blood investigations and)

研究者

发起方
Pankajakasthuri Herbals India Pvt Ltd P
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

DrJHareendran Nair

Pankajakasthuri Herbal research Foundation

研究点 (1)

Loading locations...

相似试验

A clinical Study to evaluate the safety and efficacy... | 临床试验