Validation of homoeopathic drugs for bronchial asthma

Phase 3

• Conditions: Health Condition 1: null- Bronchial Asthma

• Registration Number: CTRI/2018/04/013152
• Lead Sponsor: Central Council for Research in Homoeopathy New Delhi Ministry of AYUSH Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Willing to report for follow up even after most troublesome symptom(s) are gone.

2. Consider a diagnosis of asthma and perform spirometry if any of these indicators are present:

a. The symptoms of dyspnoea, cough and/or wheezing, especially nocturnal, difficulty in breathing or chest tightness;

b. With acute episodes: hyperinflation of thorax, decreased breath sounds, high pitched wheezing, and use of accessory muscles;

c. Symptoms worse in presence of exercise, viral infections, inhaled allergens, irritants, changes in weather, strong emotional expression, stress, menstrual cycles;

d. Reversible airflow obstruction: FEV1 >12% or >200 ml from baseline or increase in FEV1 >10% of predicted after inhalation of bronchodilator, if able to perform spirometry.

Exclusion Criteria

1. Pregnant or lactating women

2. Other diseases causing pulmonary obstruction

3. Other associated pathologies (like heart diseases, T.B.)

4. On allopathic drugs, other than for hypertension or diabetes mellitus

5. Other ongoing treatment which is likely to interfere with the course of this treatment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the change in spirometry measurement FEV1, in all patients more than 5 years old when asthma is stable at the end of 1 year of treatment.Timepoint: Baseline, 1 year

Secondary Outcome Measures

Name	Time	Method
1. To observe the change in spirometry measurements (FVC, FEV1/FVC) in all patients more than 5 years old when asthma is stable at the end of 1 year of treatment. <br/ ><br>2. To observe the change in Asthma symptom utility index at the end of 1 year of treatment. <br/ ><br>3. To observe the change in Quality of life (WHO-QoL) score at end of 1 year of treatment. <br/ ><br>Timepoint: Baseline, 1 year