A trial to study the effect of Ayurveda & Yoga in the treatment of Bronchial Asthma in Children and Adolescents.

Phase 3

Conditions: Health Condition 1: J454- Moderate persistent asthma

Registration Number: CTRI/2020/05/025321

Lead Sponsor: Centre for Integrative Medicine and Research CIMR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Diagnosed cases of Bronchial Asthma with follow up of > 6 weeks and at least 3 episodes of asthma symptoms during the previous year.

2. Moderate stable asthma defined by FEV 1 more than 60 percent and less than 80 percent of that predicted by Polgar equation.

3. Able to generate a peak inspiratory flow rate of 60 L per minute.

4. Symptoms/exacerbation (Wheeze, cough and breathlessness) more than once a week but less than once a day in frequency.

5. Night symptoms twice a month but less than once a week.

6. Parents or legal guardians willing to give written informed consent.

7. Able and willing to follow all study related instructions

Exclusion Criteria

1. Evidence of active concomitants pulmonary disease other than asthma e.g. Tuberculosis etc.

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

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

4. Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurological, immunological).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assessment of Lung Function- FEV 1, PEFR by SpirometerTimepoint: At the end of 8 weeks & 16 weeks of therapy and 4 weeks after completion of therapy

Secondary Outcome Measures

Name	Time	Method
1. Asthma Control Questionnaire & Asthma Control Questionnaire- Interviewer administered <br/ ><br>2. Fractional conc. of NO in exhaled air <br/ ><br>3. Bronchodilator reversibility <br/ ><br>4. Breath Holding time <br/ ><br>5. Paediatric Asthma QOL questionnaire <br/ ><br>6. Future Risk Monitoring <br/ ><br>a. Reduction of Asthma exacerbations <br/ ><br>b. Need for the use of short burst oral corticosteroid medication <br/ ><br>c. Average short acting beta agonist medication use <br/ ><br>7. Improvement in allergic rhinitisTimepoint: At the end of 8 weeks, & 16 weeks of therapy and 4 weeks after completion of therapy