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CTRI Number  CTRI/2017/11/010585 [Registered on: 21/11/2017] Trial Registered Prospectively
Last Modified On: 21/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management approaches for respiratory diseases 
Scientific Title of Study   Evaluating clinical efficacy of ayurvedic inhalation therapy(aerosol) and rasayan therapy in the management of COPD-a randomised cohort control clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Kajaria 
Designation  Assistant Professor 
Affiliation  All India Institute of Ayurveda 
Address  OPD Room No. 1, Hospital Block, All India Institute of Ayurveda, Mathura Road, Gautam puri, Sarita vihar, New Delhi

New Delhi
DELHI
110076
India 
Phone    
Fax    
Email  divyakajaria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divya Kajaria 
Designation  Assistant Professor 
Affiliation  All India Institute of Ayurveda 
Address  OPD Room No. 1, Hospital Block, All India Institute of Ayurveda, Mathura Road, Gautam puri, Sarita vihar, New Delhi

New Delhi
DELHI
110076
India 
Phone    
Fax    
Email  divyakajaria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nasreen Ahmed 
Designation  P.G Scholar 
Affiliation  All India Institute of Ayurveda 
Address  OPD Room No. 1, Hospital Block, All India Institute of Ayurveda, Mathura Road, Gautam puri, Sarita vihar, New Delhi

New Delhi
DELHI
110076
India 
Phone    
Fax    
Email  nasreen0902@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautam puri sarita vihar mathura road new delhi-110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Kajaria  All India Institute of Ayurveda  OPD Room No. 1, Hospital Block, All India Institute of Ayurveda, Mathura Road, Gautam puri, Sarita vihar, New Delhi
New Delhi
DELHI 
9643826221

divyakajaria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Duoline and Deriphyllin retard.Asthalin tab and Foracort inhaler  Duoline 2mg twice in a day and Deriphyllin retard(115+35mg) twice in a day for 15 days and then sos.asthalin 4mg tab and foracort inhaler 1 cap twice in a day will be given in the patient for 1 month. 
Intervention  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 haritaki rasayan in the dose of 10g with luke warm milk twice in a day for 1 month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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 ≥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. 
 
ExclusionCriteria 
Details  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.
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< 30% ).
l. Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in component of PFT including FEV1, FEVI/FVC, and PEFR.  75 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in COPD assessment test score, Modified Medical Research Council (mMRC)Questioner, St. George Respiratory disease questionnaire, SF-36 and BODE Index  75 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/04/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The outcomes of the study will be communicated to peer reviewed journals for wider dissemination 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  


Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease that is characterized by persistent respiratory symptoms and airway limitation due to alveolar 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 is characterized by chronic inflammation of the airways,lung tissue and pulmonary blood vessels as a result of exposure to inhaled irritants such as tobacco smoke. Airway re-modelling in COPD is a direct result of the inflammatory response associated with COPD and leads to narrowing of the airways. Most common respiratory symptoms in COPD include dyspnoea,cough and sputum production. COPD may be punctuated by periods of acute worsening of respiratory symptoms called exacerbations.

 

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

 

The prevalence estimates of 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 and subpopulation, the cumulative prevalence with the disease onset after 35-40 years of age increases with age. It is distinctly more common amongst men and smokers.This is largely attributed to the indoor air pollution from domestic combustion of solid fuels for cooking and heating to which women are significantly more exposed. This is particularly so in the rural and hilly areas where the solid biomass fuels are primarily used. Exposure to environmental tobacco smoke(passive smoking)from male smokers in the house is another 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 is therefore much higher than previously believed. About 3 billion people, half the worldwide population, are exposed to smoke from biomass fuel compared with 1·01 billion people who smoke tobacco, which suggests that exposure to biomass smoke might be the biggest risk factor for COPD globally. 


Despite of having enormous works on respiratory diseases like Bronchial Asthma, Bronchitis, etc., surprisingly no sufficient works have been done on COPD. As per survey of researches conducted on past few decade in Ayurvedic field, it is found that there have been no researches done in the past 10 or 20 years that shows effect of inhalation therapy on COPD through selected drugs. Looking into this need, the current study has been planned.

 
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