Health Condition 1: O- Medical and Surgical
Conditions
Interventions
None listed
Sponsors
All India Institute Of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants aged between 21 and 65 years, irrespective of gender, will be included in the study 2.Having sign and symptoms of Tamakshwasa– swasakruchhrata (dyspnea), kanthodhwansa (speak with difficulty), kasa (cough), ghurghurka sabda (wheezing/rhonchi) 3.Newly Diagnosed COPD (GOLD stage I & II): post-bronchodilator FEV1/FVC ratio less than 0.7); FEV1 greater than or equal to 50 and lesser than 80% of predicted normal; MRC dyspnoea scores greater than or equal to 2. 4.History of smoking of at least 10 pack-years. 5.Patients Having Smoking Index (greater than or equal to 200) 6.Elevated Exhaled CO levels (greater than or equal to 2ppm) measured by Smokerlyzer 7.Patients willing to provide informed written consent and comply with study procedures. 8.Not undergoing any other lung rehabilitation therapy
Exclusion criteria
Exclusion criteria: 1.COPD with life threatening complications like cor-pulmonale, respiratory failure, pneumothorax and polycythemia 2.Patient taking steroid therapy (systemic or inhaled corticosteroid) 3.Known Case of asthma. 4.History of cystic fibrosis. 5.Past or current malignancy within 5years. 6.Pregnant women and lactating mothers. 7.History of any adverse drug reactions. 8.Patients having positive HIV1 and 2 or positive Hepatitis B. 9.Patients having end stage hepatic dysfunction (defined aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 4 times of the upper normal limit) or severe renal dysfunction (defined as S. creatinine more than 1.2 mgdl),severely compromised cardiac function (EF less than 30% ). 10.Patient with poorly controlled Hypertension ( greater than 160/100 mm Hg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement(10-20%) in lung function parameter in FEV1 and FEV1/FVCTimepoint: Baseline After 15th Days After 30th Days After 45th Days After 60th Days After 75th Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction in exhaled carbon monoxide levels(10-20%) via Smokerlyzer indicating smoking cessation or reduction 2.Reduction in exhaled fractional nitric oxide(20-25%) by FeNO 3.Change in clinical scores & questionnaires: a.COPD Assessment Test (CAT) b.Modified Medical Research Council (mMRC) Questioner c.St. George’s Respiratory Questionnaire (SGRQ) d.SF-36 questionnaire (COPD-specific) 4.Change in laboratory parameters: a.CBC With ESR 5.Exercise tolerance & functional capacity: a.6-Minute Walk Distance (6MWD) b.Oxygen saturation during exercise c.Dyspnea level (BODE Index) Timepoint: Baseline After 15th days After 30th days After 45th days After 60th days After 75th days | — |
Countries
India
Contacts
Public ContactDr Divya Kajaria
All India Institute of Ayurveda
Outcome results
None listed