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
|
|
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
|
|
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. |