跳至主要内容
临床试验/CTRI/2017/11/010585
CTRI/2017/11/010585尚未招募2/3 期

Evaluating clinical efficacy of ayurvedic inhalation therapy(aerosol) and rasayan therapy in the management of COPD-a randomised cohort control clinical study

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月4日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Change in component of PFT including FEV1, FEVI/FVC, and PEFR.

研究概览

简要总结

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 25–45%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 with1·01 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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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 <0.7); FEV1 ≥50 and <80% of predicted normal; MRC dyspnoea score ≥
  • 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.

排除标准

  • 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).

结局指标

主要结局

Change in component of PFT including FEV1, FEVI/FVC, and PEFR.

时间窗: 75 days

次要结局

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

研究者

申办方类型
Research institution and hospital

研究点 (1)

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