Ayurvedic management approaches for respiratory diseases

Phase 2/3

Not yet recruiting

Conditions: 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

Registration Number: CTRI/2017/11/010585

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: Chronic obstructivepulmonary disease (COPD) is a common preventable and treatable disease that ischaracterized by persistent respiratory symptoms and airway limitation due toalveolar abnormalities caused by significant exposure to noxious particles and gases.The main risk factors for COPD are tobacco smoking, indoor air pollution,occupational exposure,outdoor air pollution,genetic factor. COPD ischaracterized by chronic inflammation of the airways,lung tissue and pulmonaryblood vessels as a result of exposure to inhaled irritants such as tobaccosmoke. Airway re-modelling in COPD is a direct result of the inflammatoryresponse associated with COPD and leads to narrowing of the airways. Mostcommon respiratory symptoms in COPD include dyspnoea,cough and sputumproduction. COPD may be punctuated by periods of acute worsening of respiratorysymptoms called exacerbations.

COPD is a major cause ofchronic morbidity throughout the world.Currently it is the fourth leading causeof death in the world.More than 3 million people died of COPD in 2012accounting for 6% of all deaths globally. According to WHO 65 million of peoplehave moderate to severe COPD worldwide.

The prevalence estimatesof COPD in India have ranged from 2 to 22% in men and 1.2 to 19% in women.There are significant differences in prevalence of COPD in different groups andsubpopulation, the cumulative prevalence with the disease onset after 35-40years of age increases with age. It is distinctly more common amongst men andsmokers.This is largely attributed to the indoor air pollution from domesticcombustion of solid fuels for cooking and heating to which women aresignificantly more exposed. This is particularly so in the rural and hillyareas where the solid biomass fuels are primarily used. Exposure toenvironmental tobacco smoke(passive smoking)from male smokers in the house isanother important risk factor for COPD in non smoker women.An estimated 25â€“45%of patients with COPD have never smoked; the burden of non-smoking COPD istherefore much higher than previously believed. About 3 billion people, halfthe worldwide population, are exposed to smoke from biomass fuel compared with1Â·01 billion people who smoke tobacco, which suggests that exposure to biomasssmoke might be the biggest risk factor for COPD globally.

Despite of having enormous works on respiratory diseases likeBronchial Asthma, Bronchitis, etc., surprisingly no sufficient works have beendone on COPD. As per survey of researches conducted on past few decade inAyurvedic field, it is found that there have been no researches done inthe past 10 or 20 years that shows effect of inhalation therapy on COPD throughselected drugs. Looking into this need, the current study has beenplanned.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

a.Age- 18-60 years.
b.Both male and female c.Smokers and ex-smoker with smoking historyâ‰¥10 pack-years d.Newly diagnosed COPD (GOLD stage I & II): post-bronchodilator FEV1/FVC ratio <0.7); FEV1 â‰¥50 and <80% of predicted normal; MRC dyspnoea score â‰¥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.
No acute exacerbation of COPD.
Clinically being stable for one month and longer.
h.Not undergoing exercise training program or any other lung rehabilitation therapy.

Exclusion Criteria

a.COPD of GOLD stage III & IV with FEV1<50%.
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.
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< 30% ).
l.Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in component of PFT including FEV1, FEVI/FVC, and PEFR.	75 days

Secondary Outcome Measures

Name	Time	Method
Change in COPD assessment test score, Modified Medical Research Council (mMRC)Questioner, St. George Respiratory disease questionnaire, SF-36 and BODE Index	75 days

Trial Locations

Locations (1): All India Institute of Ayurveda
🇮🇳
Delhi, DELHI, India
All India Institute of Ayurveda
🇮🇳Delhi, DELHI, India
Dr Divya Kajaria
Principal investigator
9643826221
divyakajaria@gmail.com