Health Condition 1: J454- Moderate persistent asthma
Conditions
Interventions
Intervention1: Docosahexaenoic acid: This is single arm trial, Docosahexaenoic acid (1000 mg/day) supplementation along with inhaled budesonide with or without LABA (400 to 1000 micg/day) for 2 months
Morning 2 capsule, after noon 2 capsule and night 1 capsule for 2 months. Then based on the lung function and symptoms score, the dose of budesonide will be gradually reduced to low dose till the achi
Sponsors
Council of Scientific and Industrial Research
Eligibility
Inclusion criteria
Inclusion criteria: â??Steroid refractory asthmaâ?? should be diagnosed as per American Thoracic Society workshop that was conducted in year 2000 (for the convenience the contents of Table 1 of published report â??Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations, and unanswered questions. American Thoracic Society. [No authors listed] Am J Respir Crit Care Med. 2000 Dec;162(6):2341-51.â?? has been given here). The workshop had devised two major and seven minor criteria. According to the workshop, a patient can be defined as steroid refractory if that patient has one or both major and minimum two minor criteria. Major criteria: To attain a control to a level of mild-moderate persistent asthma patient, will be based on: 1. Treatment with continuous or near continuous ( >50% of year) oral corticosteroids 2. Requirement for treatment with high-dose inhaled corticosteroids Minor Criteria: 1. Requirement for daily treatment with a controller medication in addition to inhaled corticosteroids, e.g., long-acting β-agonist, theophylline, or leukotriene antagonist 2. Asthma symptoms requiring short-acting β-agonist use on a daily or near daily basis 3. Persistent airway obstruction (FEV1, 80% predicted; diurnal PEF variability >20%) 4. One or more urgent care visits for asthma per year 5. Three or more oral steroid "bursts" per year 6. Prompt deterioration with 7. Near fatal asthma event in the past.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Patients with liver disease 3. Patients with coronary artery disease or any other serious heart diseases like arrhythmias, heart attacks, strokes and heart failures 4. Alcoholic intake in the last year before recruitment. 5. Life-threatening asthmatic condition in the last one year before the recruitment. 7. Hospitalized for asthmatic attack/exacerbation or severe lung infection in the last one month before recruitment. 8. Use of DHA capsules or other nutritional supplements that contains DHA at the time of recruitment. 9. Allergic to fish foods/oils 10. Active smokers with at least 10 pack years in case of asthma 11. Known case of HIV and other lung diseases like lung cancer, tuberculosis, Broncho pulmonary aspergillosis, cystic fibrosis, and bronchiectasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 25 % reduction in the dose of steroids 2. Improvement in Lung functions (FEV1) Timepoint: Every 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The controlled asthma with the â??Asthma Control Questionnaireâ?? score less than 1. 5. [asthma control questionnaire, a valid score in clinical practice of asthma, is based on 7-point scale considering 6 questions like night time waking and lung function test]. 2. Reduction in serum inflammatory mediators like IL-17A and other steroid responsive cytokines like IL-8, RANTES, MIP-2 etc. 3. The expression of RXR in PBMC (peripheral blood mononuclear cells) Timepoint: Every 30 days | — |
Countries
India
Contacts
Public ContactU Mabalirajan
CSIR-Indian Institute of Chemical Biology
Outcome results
None listed