Effect of Ashtaangaavaleha and Vyaaghreeharetakee Avaleha (herbal drug combination in semisolid form) in Asthmatic Childre

Phase 2

Recruiting

• Conditions: Health Condition 1: null- Tamaka Shwaasa (Bronchial Asthma)

• Registration Number: CTRI/2011/10/002059
• Lead Sponsor: The Director

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Diagnosed cases of Tamaka Shwasa Bronchial Asthma with at least 3 episodes of asthma symptoms during the previous year

Severity as mild to moderate stable asthma defined by FEV 1 more than 60 persent and less than 80 persent of that predicted by Polgar equation

Able to generate a peek inspiratory flow rate of 60 L per minute

Patients on other drug therapy will be included only after completion of wash out period prescribed

Parents legal guardians willing to give written informed consent

Exclusion Criteria

Evidence of active concomitants pulmonary disease other than asthma

Evidence of requirement of intubations for asthma, or had been hospitalized for asthma within one month before

Had unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 3 weeks

More than 4 short courses of oral corticosteroids within the year preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks

Use of Astemizole, Nedocromil, Cromolyn, long acting β agonists, Ketotifen, or Theophylline within 2 weeks before

Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Tamaka Shwasa vis a vis Bronchial Asthma, <br/ ><br> <br/ ><br>Improvement in pulmonary function tests parameters, <br/ ><br> <br/ ><br>Improvement in frequency and severity in daytime asthma symptoms, overnight asthma symptoms cough, wheezing, trouble breathing and activity limitation <br/ ><br> <br/ ><br>Timepoint: Both groups will be assessed before treatment period and after eight weeks of treatment period <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Positive changes in blood picture, <br/ ><br> <br/ ><br>Reduction in Eosinophils count in blood chemistry, <br/ ><br> <br/ ><br>Improvements in Ig E antibody levels in serum, <br/ ><br> <br/ ><br>The improvement in QOL (Quality of life Parameters) <br/ ><br>Timepoint: Both groups will be assessed before treatment period and after eight weeks of treatment period