Health Condition 1: null- Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects aged between 18 and 60 years and of both sexes and suffering from GOLD stage I to III COPD and subjects giving written informed consent will be included in the study
Exclusion criteria
Exclusion criteria: Very severe cases GOLD stage IV with FEV1 less than 30 percent predicted or less than 50 percent with chronic respiratory failure Presence of severe concomitant diseases Patient developing chronic respiratory failure or cor pulmonale as detected clinically Failure of vital organs or systems like heart lungs liver kidney etc. Continuing systemic glucocorticoid therapy since last 3 months Uncontrolled hypertension or diabetes mellitus Presence of any systemic endocrinal cardiovascular locomotor neurological hematological metabolic or serious infectious disease like tuberculosis pneumonia etc. already diagnosed or detected clinically or by routine laboratory investigations Immune-compromised patients Diagnosed cases of developmental defects or congenital abnormalities Patients with pregnancy breast feeding and likelihood of pregnancy History of drug or alcohol abuse Inability to comply with the study protocol including psychiatric diseases and If any exclusion criteria develop during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in dyspnea VAS, modified Borg scale, shortness of breath questionnaire, cough VAS, Leicester cough questionnaire, COPD assessment test, Saint George respiratory questionnaire, clinical COPD questionnaire, baseline and transitional dyspnea index, sleep VAS, medical outcome study sleep, patients global impression of change scale, 6 minute walk testTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum interleukin 6 level, FEV1, IC/TLC, number of acute exacerbations, extent of lowering of dosage of conventional medicineTimepoint: 12 months | — |
Countries
India
Contacts
Medical College Kolkata