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

Clinical efficacy of addition of Agastya Haritaki avaleha [Classical Ayurvedic formulation] and Yoga to standard treatment care in the management of Bronchial Asthma in Children and Adolescents. A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025321

Enrollment

236

Registered

2020-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J454- Moderate persistent asthma

Interventions

Intervention1: Ayurveda and /or Yoga with Standard Care: The active treatment in group I will be Ayurveda with Standard treatment of care. The treatment in Group II will be Yoga with Standard treatmen

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Rakesh Lodha

All India Institute of Medical Sciences

rakesh_lodha@hotmail.com011-26593621

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026