Health Condition 1: J452- Mild intermittent asthma
Conditions
Interventions
Intervention1: AYUSH-A: ayurvedic coded drug in a dose of 2gm TDS orally [3tablets (one tab. with active ingredient of 666.7mg) at a time, thrice daily] with lukewarm water after food for twelve weeks
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES MINISTRY OF AYUSH GOVERNMENT OF INDIA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of any gender with age between 18 to 60 years. 2. Patients with mild tomoderate stable Bronchial Asthma (TamakaSwasa) (as per GINA Guidelines 2020 recommendations) and on regular and stable dose of inhaled therapy (medium â?? high dose ICS alone or ICS+LABA) for at least 4 weeks prior to study entry. 3. Patients willing to participate and provide written consent.
Exclusion criteria
Exclusion criteria: 1. Patients with H/O acute exacerbation of respiratory symptoms during last four weeks 2. Patients with evidence of malignancy. 3. Chronic obstructive pulmonary disease, pneumonia, lung cancer and other chronic lung diseases 4. Patients under treatment for Pulmonary TB or with a diagnosis of Pulmonary TB. 5. Patients with uncontrolled Diabetes Mellitus assessed by fasting blood sugar or HbA1c >7.5%. 6. Patients with unstable cardiovascular disease. 7. Patients suffering from other major systemic illness necessitating long term drug treatment (eg: Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 8. Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases 9. Patients with concurrent serious hepatic disorder or Renal Disorders 10. Active smokers, alcoholics and/or any form of drug abusers 11. H/o hypersensitivity to the trial drug or any of its ingredients. 12. Pregnancy or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in FEV1 and FVC measured every four weeksTimepoint: â?¢ Change in FEV1 and FVC measured every four weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change in PEFR measured every four weeks â?¢Change in Asthma Quality of Life Questionnaire (AQLQ) from the baseline and every follow-up. â?¢Reduction in usage of rescue medication â?¢Number of unscheduled hospital / emergency visits or hospitalizations during the study period â?¢Incidence of treatment emergent adverse events â?¢Proportion of participants who required hospital visits/ hospitalization (other than the routine planned study follow-ups) during the study period Timepoint: EVERY FOUR WEEK | — |
Countries
India
Contacts
Public ContactProf Anant Mohan
All India Institute of Medical Sciences
Outcome results
None listed