Health Condition 1: J452- Mild intermittent asthma
Conditions
Interventions
Intervention1: 1)Individualised Homeopathic Medicine
2) Standard of
: All the subjects will be treated with Standard of Care asthma treatment as per GINA 2023 guidelines throughout the trial period.
Sponsors
Ministry of AYUSH Through CCRH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Properly completed patient informed consent 2. Male or female and transgender aged at least 18 years /Children above 12 years can be included 3. Clinical history consistent with asthma. 4. Diagnosed asthmatics who may or may not be receiving treatment shall be inclusive. 5.Willingness and ability to sign ethics committee approved Informed Consent Form shall be inclusive. In case of illiterate subjects signature of an LAR shall be acceptable.
Exclusion criteria
Exclusion criteria: 1) Infants and children below age of 12 years shall not be eligible. 2) Pregnant and nursing women shall be excluded. 3) Subjects having a history or symptoms of viral infection with in past 1 week shall be excluded. 4) Subjects having an acute exacerbation of asthma within 4 weeks shall be excluded for spirometry. 5) Subjects requiring oral corticosteroids shall be excluded. 6) Subjects not withholding prohibited drugs for the specified time period shall be excluded. 7)Subjects suffering from life threatening diseases will be excluded. 8) Subjects having a history of near fatal asthma requiring intubation and mechanical ventilation will be excluded. 9) subjects with history of hospitalisation for asthma in past 1 year will be excluded. 10) Subjects having history of anaphylactic reaction in the past will be excluded. 11) Subjects taking any homoeopathic therapy or preparation in any form shall be excluded. 12) Asthmatic with food allergy as a trigger for asthma will be excluded. 13) Subjects with COPD shall be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The change in mean overall AQLQ score from base line in 28 weeks 2) The change in FEV1 from base line in 28 weeks Timepoint: 1)Baseline data -Before Randomozation 2) Interim analysis - at the end of week 12 3) Final analysis - at the time of study completion or withdrawal | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Decrease in Total serum IgE level from baseline till the end of 28 weeks in subjects with raised total IgE levels at base line. 2) Decrease in AEC from baseline to end of 28 weeks in subjects with raised AEC at the baseline 3) Decrease in Sputum eosinophils count from baseline till end of 28 weeks in subjects with raised Sputum eosinophils count at the baseline.Timepoint: 1)Baseline data -Before Randomozation 2) Interim analysis - at the end of week 12 3) Final analysis - at the time of study completion or withdrawal | — |
Countries
India
Contacts
Public ContactDr Jignya Shah
Holistic Health Foundation
Outcome results
None listed