Health Condition 1: null- Patients of either sex with age between 18 to 60 years, smokers and ex-smokers with smoking history of more than 10 pack years and newly diagnosed COPD with GOLD stage I and II
Conditions
Interventions
Intervention1: H-4 Ayurvedic Nebulizer(shrish,nagarmotha,kantakari,tulsi).Agastya Haritaki Rasayan: H-4 Ayurvedic compound in the dose of 2.5ml twice in a day for first 15 days then sos.agastya harita
Sponsors
All India Institute of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: a. Age- 18-60 years. b. Both male and female c. Smokers and ex-smoker with smoking history>=10 pack-years d. Newly diagnosed COPD (GOLD stage I & II): post-bronchodilator FEV1/FVC ratio =50 and =2. e. Ability to demonstrate compliance with handy-inhaler, a salbutamol Meter Dose Inhaler, and the activity monitor; perform acceptable Pulmonary FunctionTests; an exercise stress test and can follow study procedures. f. No acute exacerbation of COPD. g. Clinically being stable for one month and longer. h.Not undergoing exercise training program or any other lung rehabilitation therapy.
Exclusion criteria
Exclusion criteria: a. COPD of GOLD stage III & IV with FEV1 b. COPD with life threatening complications like cor-pulmonale, respiratory failure, pneumothorax and polycythemia. c. Any history of previous chronic infectious respiratory disease like tuberculosis, URTI, acute bronchitis, pneumonia. d. Patient taking steroid therapy from long duration (systemic or inhaled corticosteroid) e. Diagnosis of asthma. f. History of cystic fibrosis. g. Past or current malignancy within 5years. h. Pregnant ladies and lactating mothers. i. History of any adverse drug reactions. j. Patients having positive HIV1 and 2 or positive Hepatitis B. k. Patients having end stage hepatic dysfunction (defined asaspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 4 times of the upper normal limit) or severe renal dysfunction (defined as S. creatinine > 1.2 mg/dl),severely compromised cardiac function (EF l. Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in component of PFT including FEV1, FEVI/FVC, and PEFR.Timepoint: 75 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in COPD assessment test score, Modified Medical Research Council (mMRC)Questioner, St. George Respiratory disease questionnaire, SF-36 and BODE IndexTimepoint: 75 days | — |
Countries
India
Contacts
Public ContactDr Nasreen Ahmed
All India Institute of Ayurveda
Outcome results
None listed