CTRI/2022/07/044267 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On:
14/06/2022
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Single Arm Study
Public Title of Study
Effect of Ayurveda treatment in the Management of Tamaka Shwasa(Bronchial Asthma)
Scientific Title of Study
Clinical trial to study the Effect of Vyoshadi Granules, Vasadi Kashaya & Erand Bhrishta Haritaki in Tamaka Shwasa (Bronchial Asthma)
Trial Acronym
Ayurveda treatment in Bronchial Asthma
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rahul Kumar Duchaneya
Designation
MD SCHOLAR
Affiliation
National Institute of Ayurveda
Address
P.G. Department of Kayachikitsa National Institute of Ayurveda,
Jaipur-302002
P.G. Department of Kayachikitsa National Institute of Ayurveda,
Jaipur-302002 Jaipur RAJASTHAN 302002 India
Phone
8769834903
Fax
Email
rahulkumarpinkcity@gmail.com
Details of Contact Person Scientific Query
Name
Dr Abhishek Upadhyay
Designation
Assistant Professor
Affiliation
National Institute of Ayurveda
Address
PG Department of Kayachikitsa, National Institute of Ayurveda, Johawar Singh Gate,
Amer road, Jaipur National Institute of Ayurveda, Johawar Singh Gate,
Amer road, Jaipur Jaipur RAJASTHAN 302002 India
Phone
9915613039
Fax
Email
dr.abhishek82@gmail.com
Details of Contact Person Public Query
Name
Dr Abhishek Upadhyay
Designation
Assistant Professor
Affiliation
National Institute of Ayurveda
Address
PG Department of Kayachikitsa, National Institute of Ayurveda, Johawar Singh Gate,
Amer road, Jaipur National Institute of Ayurveda, Johawar Singh Gate,
Amer road, Jaipur Jaipur RAJASTHAN 302002 India
Phone
9915613039
Fax
Email
dr.abhishek82@gmail.com
Source of Monetary or Material Support
National Institute of Ayurveda, Deemed to be University
Primary Sponsor
Name
National Institute of Ayurveda
Address
Johawar Singh gate,
Amer road, Jaipur, Rajasthan
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
Rahul Kumar Duchaneya
National Institute of Ayurveda
OPD NO, 1, 7 18, 22, 25, PG Department of Kayachikitsa, NIA, Mhadav Vilas Palace, Amer Road, Jairpur, Jaipur RAJASTHAN
8769834903
rahulkumarpinkcity@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics committee, National Institute of Ayurveda
• Patients willing to participate and sign consent in the clinical trial.
• Patients in the age group of 18-65 yrs.
• Patients with Intermittent, mild-persistent & moderate-persistent asthma and are not on regular medication for Asthma.
• Patients having FEV1 > 60% of predicted value
• Patients of Rhinitis with spirometric evidence of reversible airflow obstruction.
• Patients who have not received any AYUSH intervention in last 15 days for related symptoms
ExclusionCriteria
Details
• Patients having severe persistent (FEV1 <60 % of predicted) and Acute exacerbation of asthma
• Diagnosed cases of tuberculosis, pneumonia, COPD and other acute and chronic pulmonary disorders
• K/c/o malignancies of the respiratory and other system.
• Patients who have consumed AYUSH intervention for related complaints in last 15 days.
• Patients on regular anti allergic medications, on regular inhaled, intranasal or oral steroids.
• Patients on immunotherapy for allergy.
• Patients with Haemoglobin less than 9 mg/dl.
• Patients having concomitant systemic illness like uncontrolled Hypertension, Poorly controlled Diabetes Mellitus, Renal failure, Malignancy, Acute or Chronic liver disease.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
• Forced Expiratory Volume in first second (FEV1) from baseline values.
56 days
Secondary Outcome
Outcome
TimePoints
• Improvement in Peak expiratory flow rate (PEFR).
• Changes in IgE & Absolute Eosinophil count
• Degree of improvement in asthma related symptoms on the basis of Asthma control questionnaire (ACQ)
• Degree of Improvement in Total Nasal Symptom Score (TNSS)
56 days
Target Sample Size
Total Sample Size="30" Sample Size from India="30" 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
Date of First Enrollment (India)
01/09/2022
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="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Non Yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Introduction:
ShwasaRoga
inAyurveda is described as a
presenting feature of Pranvahasrotodusti.Acharya Charaka has
described Hridaya and Mahasrotasa[i]whereas Acharaya Sushruta
considered Hridaya and RasavahiniDhamanyaha as the Mool of Pranvahasrotasa.[ii]
Shwasa or difficulty in breathing may appear as an individual disease
termed as SwatantraVyadhi in Ayurveda or sometimes it may
appear as a symptom of other diseases and so long as this exists as secondary
it is termed as PartantraVyadhi. Charaka has described 5 types
of Shwasa viz Mahashwasa, UrdhavaShwasa, ChinnaShwasa, TamakShwasa and KshudraShwas.[iii]
Out of these first three are considered as Asadhya as per AyurvedicClassics whereas KshudraShwasa does not require any treatment and TamakaShwasa is
considered as Yapya. According to
principles of Ayurveda,Shwasa is a Kaphavata dominant disease which originates
from Pittasthana.[iv]
Obstruction in the PranavahaSrotas due to accumulation of KaphaDosha causes vitiation of Vayu
which further attains Pratilomgati to create the pathogenesis of Tamak
Shwasa Roga.[v] Shwasa on the basis of its clinical
features and etiopathogensis bears a close resemblance to bronchial asthma.
Bronchial asthma is a chronic inflammatory disease of the airways that causes
airway hyper responsiveness, mucosal edema, mucus production and airway
remodeling. This inflammation ultimately leads to recurrent episodes of asthma
symptoms like Cough, chest tightness, dyspnoea and wheezing.[vi]
Asthma is a major
non-communicable disease affecting both children and adults, with high
morbidity and mortality. According to WHO, in
2016 235 million people were having
asthma worldwide, out of which 15–20 million people are from India. In India,
the prevalence of self-reported Asthma is 2.00% among women aged 15–49 years
and 1.00% among young women aged 15–19 years as well as men aged 15–49 years as
per the latest report.[vii]
Need of Study:
Significant number of patient visit
Ayurvedic health care facilities for the treatment of conditions presenting
with Shwasa. Shwasa is a broad
term and can be due to multi system disorders like Asthma, COPD, pneumonia, tuberculosis, sarcoidosis, heart failure,
pleural effusion, pericardial effusion, anemia, renal failure etc. Shodhan,
Shaman, Brihmana and Vatanulomana are the main treatment principles of Shwasa
according to Ayurveda.
Charak has
given following guidelines for the treatment of Shwasa:-
As per
cited references Kapha-VataShamak, Ushna, Vatanulomana & Nitya virechana are the treatment principles
advocated for Shwasa. It is necessary to study and interpret the effect
of Ayurveda treatment principles in present day diseases presenting with Shwasa
(Dyspnoea). For present clinical study, Asthma was selected to assess the
effect of Ayurveda treatment using whole system approach. Vyoshadi Granules and Vasadi kashaya having
Kapha-Vata shamak and Ushna
properties and Eranda Bhrista Haritaki having Vatanuloman and
Nitya Virechana qualities are selected to study their effect in
patients with Asthma. In addition to drugs, diet according to principles of Shwasa Chikitsa will be
advised to the patients during the study period.
Aims and Objective:
Aim:
•To study
the effect of Vyoshadi Granules, Vasadi Kashaya & Erand bhrishta haritaki
in Tamaka Shwasa(Bronchial Asthma).
Objective:
•To
study the effect of “Vyoshadi Granules, Vasadi Kashaya
& Erand Bhrishta Haritakiâ€
on FEV1 & PEFR in patients of Bronchial Asthma.
•To
study the effect of “Vyoshadi Granules, Vasadi Kashaya
& Erand Bhrishta Haritakiâ€
in signs & symptoms of Tamak Shwasa/Bronchial Asthma.
•To study the effect of “Vyoshadi
Granules, Vasadi Kashaya & Erand Bhrishta Haritaki†on signs & symptoms of Pratishyaya (Allergic
Rhinitis).
Previous work done:
Literature review has shown that at NIA Jaipur, Department of Kayachikitsa around 13 researches
works have been done on Tamaka Shwasa (Bronchial Asthma) till 2019. Most the works have been
carried out using the single drugs or comparing Shodhan and Shaman. The research
works done on Tamaka Shwasa are as follows
1986
Chikkara
V.V.
A clinical study of Shodhanottara Bharangyadi Kwatha in Tamak Shwasa(Br.
Asthma)
1986
Sharma
R.K.
Pushkarmula, Lavanga Evem
Talisha Patra Ka Shwasahara Karmatamaka Adhayana.
1989
Sharma
(Ms)S.
Tamaka Shwasa Mein Sudharka Yoga Ki Karmukata
1991
Joshi
S.L.
Tamaka Shwasa Mein Shodhanottara Shwasa Kuthar Rasa Ka Chitikitsatamaka
Adhayana
1993
Tripati
A.N.
Tamaka Shwasa Main Shwasa Kasari Kasa Ka Shodana Purva Evem Paschata
Chikitsakiya Tulnatamaka Adhayana.
2008
Kajaria
D.
Clinical
Evaluation of the Bharangi – Nagaradi Yoga
and Herbal Nebuliser in the Managament of Tamaka
Shwasa.
2011
Sharma
S.K.
Clinical
Evaluation of “ Shringyadi Churnaâ€
with different Anupana
in the management of Bronchial Asthma
2012
Mundada
S.R.
Clinical
Evaluation of “Vyaghari Haritikiâ€
in the management of Bronchial Asthma.
2014
Mutha
R.
A
Clinical Evaluation of Haridradi Leha
And Vasadi Kashaya in the
Management of Tamaka Shwasa (Bronchial Asthma)
2015
Kaur
M.
A
Comparative Study of Efficacy and safety of Pushkarmooladi
Yoga and Bharangi NagarKwatha in Management of Tamaka Shwasa w.s.r. to Chronic Obustructive Pulmonary
Disease (COPD)
2116
Bairwa
D.K.
Comparative
Study of Efficacy and safety of KrishnadiChurna And Vasadi Kwatha
in TamakaShwasa
w.s.r. to Bronchial Asthma
2018
Shakya
N.
Clinical
Evaluation of Haridradi Avleha
and Virechana Karma
in the managment of TamakaShwasa w.s.r. to Bronchial
Asthma.
2019
Meena Babita
A Randomized Comparative Clinical Trial To Evaluate
The Efficacy of Kulattha Guda With
and Without Virechana Karma in The
Management of
Tamaka
shwasa (Bronchial Asthma)
STUDY OUTCOMES:
Material and
Methods:
Following
materials and methods will be adopted for conducting the present clinical
trial.
A)
Selection of Cases:
•The patients presenting to OPD &
IPD of National Institute of Ayurveda, Hospital, Jaipur with Shwasa
(dyspnoea), cough, chest tightness, wheezing and one or more symptoms of
Allergic rhinitis viz. nasal congestion, runny nose, itchy nose, or sneezing
will be screened and those meeting the criteria of inclusion will be included
in the study.
•Spirometry will be performed in
patients presenting with above mentioned complaints. Those showing reversible
changes (>12% or >200 ml improvement in FEV1) post bronchodilator will be
diagnosed as bronchial asthma. Severity will be classified as per the GINA (Global Initative
for Asthma) guidelines. (Table 1)
•Written informed consent of the patient
will be taken before the procedure and careful history, physical examination
and necessary investigations will be performed.
Table 1: Classification
of Asthma Severity as per GINA guidelines
Components of
severity
Classification of Asthma
severity
Intermittent
Mild persistent
Moderate persistent
Severe persistent
Symptoms
≤ 2 days/week
>2 days/week but not daily
Daily
Throughout day
Nighttime awakenings
≤ 2 times/month
3-4times/month
>1times/week, but not nightly
Often 7 times a week
SABA use
≤ 2 days/week
>2 days/week but not>1 time/day
Daily
Several times per day
Intereferance with activity
None
Minor limitation
Some limitation
Extremely limited
Lung function
FEVI >80%
FEV1/FVC normal
FEV1 ≥80% predicated FEV1/FVC normal
FEV1 60-80% predicated
FEV1/FVC reduced 5%
FEV1 <60% predicated
FEV1/FVC
reduced >5%
Method of spirometry:
A
soft clip will be placed on the nose of the patients to keep both nostrils
closed. Patients will be instructed to take a deep breath in, hold it for a few
seconds, and then exhale as hard as patient can into the mouthpiece of
spirometer. The procedure will be repeated three times to record the readings
to make sure the values are consistent. Patients will be then given an inhaled
short acting bronchodilator through nebulizer. The procedure will be repeated
again after 15 minutes to record another three recordings. Pre and post
bronchodilators values will be compared.
•Increase
in FEV1 by >200 ml and >12% from the baseline value after inhaling a
bronchodilator, will be considered as significant bronchodilator responsiveness
or reversibility.
[i]Agnivesha, Charakasamhita, VimanSthana,
SrotovimanAdhyaya, 5/7, Vidyotinihindi commentary by Pt.
KashinathaShastri & Dr. GorakhanathaChaturvedi, Part -1, ChaukhambhaBharati
Academy, Varanasi, 2006; 710.
[ii]Susruta, Susruta Samhita, SharirSthan,
DhamnivyakarnaSharir, 9/12, edited by
Ayurveda TattvaSandipika, Commentary by KavirajaAmbikaduttaShastri,
Part-1,Chaukhambha Sanskrit Sansthan, Varanasi, 2009; 96.
[iii]Agnivesha, Charakasamhita, SutraSthana,
AshtoudariyaAdhyaya, 19/4, Vidyotinihindi commentary by Pt.
KashinathaShastri& Dr. GorakhanathaChaturvedi, Part -1, ChaukhambhaBharati
Academy, Varanasi, 2006; 389.
[iv]Agnivesha, Charakasamhita, ChikitsaSthana, Hikkashwasa
Chikitsa Adhyaya, 17/8-9, Vidyotinihindi commentary by Pt.
KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharati
Academy, Varanasi, 2006.
[v]Agnivesha, Charakasamhita, ChikitsaSthana, Hikkashwasa
Chikitsa Adhyaya, 17/55-62, Vidyotinihindi commentary by Pt.
KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharati
Academy, Varanasi, 2006; 567.
[vi]According to the global initiative for
Asthma (GINA) : O Byrne p. GINA
Executive Committee. Global strategy for asthma management and prevention,2004.
National Institutes of Health. Publication N0 02-3659.
[vii]Singh, S.K., Gupta, J., Sharma,
H. et al. Socio-economic Correlates and Spatial Heterogeneity
in the Prevalence of Asthma among Young Women in India. BMC Pulm Med20, 190
(2020). https://doi.org/10.1186/s12890-020-1124-z
[viii]Agnivesha, Charakasamhita, ChikitsaSthana,
Hikkashwasa Chikitsa Adhyaya, 17/147, Vidyotinihindi commentary by Pt.
KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharati
Academy, Varanasi, 2006; 525.
[ix]Agnivesha, Charakasamhita, ChikitsaSthana, Hikkashwasa
Chikitsa Adhyaya, 17/121, Vidyotinihindi commentary by Pt. KashinathaShastri&
Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharati Academy, Varanasi,
2006; 525.
[x]Agnivesha, Charakasamhita, ChikitsaSthana, Hikkashwasa
Chikitsa Adhyaya, 17/122, Vidyotinihindi commentary by Pt.
KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharati
Academy, Varanasi, 2006; 525.
[x]Weitzman RE, Feng AL,
Justicz N, Gadkaree SK, Lindsay RW. Unilateral Nasal Obstruction Causes Symptom
Severity Scores Similar to Bilateral Nasal Obstruction. Facial Plast Surg. 2020
Aug;36(4):487-492. doi: 10.1055/s-0040-1714265. Epub 2020 Jul 27.