Clinical trial to study the Effect of Vyoshadi Granules, Vasadi Kashaya & Erand Bhrishta Haritaki in Tamaka Shwasa (Bronchial Asthma)

Introduction:Shwasa RogainAyurveda is described as apresenting feature of Pranvahasrotodusti. Acharya Charaka hasdescribed Hridaya and *Mahasrotasa[i]*whereas Acharaya Sushrutaconsidered Hridaya and Rasavahini Dhamanyaha as the Mool of Pranvahasrotasa.[ii]Shwasa or difficulty in breathing may appear as an individual diseasetermed as Swatantra Vyadhi in Ayurveda or sometimes it mayappear as a symptom of other diseases and so long as this exists as secondaryit is termed as Partantra Vyadhi. Charaka has described 5 typesof Shwasa viz Mahashwasa, Urdhava Shwasa, Chinna**Shwasa, Tamak Shwasa and Kshudra Shwas.[iii]Out of these first three are considered as Asadhya as per  Ayurvedic Classics whereas Kshudra**Shwasa does not require any treatment and Tamaka Shwasa isconsidered as Yapya.  According toprinciples of Ayurveda, Shwasa is a Kaphavata dominant disease which originatesfrom *Pittasthana.[iv]*Obstruction in the Pranavaha Srotas due to accumulation of Kapha**Dosha causes vitiation of Vayuwhich further attains Pratilomgati to create the pathogenesis of TamakShwasa Roga.[v] Shwasa on the basis of its clinicalfeatures and etiopathogensis bears a close resemblance to bronchial asthma.Bronchial asthma is a chronic inflammatory disease of the airways that causesairway hyper responsiveness, mucosal edema, mucus production and airwayremodeling. This inflammation ultimately leads to recurrent episodes of asthmasymptoms like Cough, chest tightness, dyspnoea and wheezing.[vi]        Asthma is a majornon-communicable disease affecting both children and adults, with highmorbidity and mortality. According to WHO, in2016  235 million people were havingasthma 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 yearsand 1.00% among young women aged 15–19 years as well as men aged 15–49 years asper the latest report.[vii]Need of Study:                                                                                                              Significant number of patient visitAyurvedic health care facilities for the treatment of conditions presentingwith Shwasa. Shwasa is a broadterm 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 Shwasaaccording to Ayurveda.

Charak hasgiven following guidelines for the treatment of Shwasa:-

यतà¥à¤•à¤¿à¤žà¥à¤šà¤¿à¤¤à¥ à¤•à¤«à¤µà¤¾à¤¤à¤˜à¥à¤¨à¤®à¥à¤·à¥à¤£à¤‚ à¤µà¤¾à¤¤à¤¾à¤¨à¥à¤²à¥‹à¤®à¤¨à¤®à¥| भेषजं à¤ªà¤¾à¤¨à¤®à¤¤à¥à¤°à¤‚ à¤µà¤¾ à¤¤à¤¦à¥à¤§à¤¿à¤¤à¤‚ à¤¶à¥à¤µà¤¾à¤¸à¤¹à¤¿à¤•à¥à¤•à¤¿à¤¨à¥‡|| (Ch.chi.17/147)[viii]

वातशà¥à¤²à¥‡à¤·à¥à¤®à¤¹à¤°à¥ˆà¤°à¥à¤¯à¥à¤•à¥à¤¤à¤‚ à¤¤à¤®à¤•à¥‡ à¤¤à¥ à¤µà¤¿à¤°à¥‡à¤šà¤¨à¤®à¥||                                                                                (Ch.chi.17/121)[ix]

उदीरà¥à¤¯à¤¤à¥‡ à¤­à¥ƒà¤¶à¤¤à¤°à¤‚ à¤®à¤¾à¤°à¥à¤—रोधादà¥à¤µà¤¹à¤œà¥à¤œà¤²à¤®à¥| यथा à¤¤à¤¥à¤¾à¤½à¤¨à¤¿à¤²à¤¸à¥à¤¤à¤¸à¥à¤¯ à¤®à¤¾à¤°à¥à¤—ं à¤¨à¤¿à¤¤à¥à¤¯à¤‚ à¤µà¤¿à¤¶à¥‹à¤§à¤¯à¥‡à¤¤à¥||    (Ch.chi.17/122)[x]

As percited references Kapha-Vata Shamak, Ushna, Vatanulomana & Nitya virechana are the treatment principlesadvocated for Shwasa. It is necessary to study and interpret the effectof Ayurveda treatment principles in present day diseases presenting with Shwasa(Dyspnoea). For present clinical study, Asthma was selected to assess theeffect of Ayurveda treatment using whole system approach. Vyoshadi Granules and Vasadi kashaya havingKapha-Vata shamak and Ushnaproperties and Eranda Bhrista Haritaki having Vatanuloman andNitya Virechana qualities are selected to study their effect inpatients with Asthma. In addition to drugs, diet according to principles of Shwasa Chikitsa will beadvised to the patients during the study period.

Aims and Objective:  Aim:•      To studythe effect of Vyoshadi Granules, Vasadi Kashaya & Erand bhrishta haritakiin Tamaka Shwasa(Bronchial Asthma).

 Objective:

 â€¢        Tostudy the effect of “*Vyoshadi Granules, Vasadi Kashaya& Erand Bhrishta Haritaki**â€*on FEV1 & PEFR in patients of Bronchial Asthma.

•        Tostudy the effect of “*Vyoshadi Granules, Vasadi Kashaya& Erand Bhrishta Haritaki**â€*in signs & symptoms of Tamak Shwasa/Bronchial Asthma.

•        To study the effect of “VyoshadiGranules, Vasadi Kashaya & Erand Bhrishta Haritaki**†on signs & symptoms of Pratishyaya (AllergicRhinitis).

Previous work done:

Literature review has shown that at NIA Jaipur, Department of   Kayachikitsa around 13 researchesworks have been done on Tamaka Shwasa (Bronchial Asthma) till 2019. Most the works have beencarried out using the single drugs or comparing Shodhan and Shaman*.* The researchworks 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 Churna†with different Anupana in the management of Bronchial Asthma

|2012

Mundada S.R.

Clinical Evaluation of “Vyaghari Haritiki†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 Nagar Kwatha 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 Krishnadi Churna And Vasadi Kwatha in Tamaka Shwasa w.s.r. to Bronchial Asthma

|2018

Shakya N.

Clinical Evaluation of Haridradi Avleha and Virechana Karma in the managment of Tamaka Shwasa 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 andMethods:

Followingmaterials and methods will be adopted for conducting the present clinicaltrial.

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 ofAllergic rhinitis viz. nasal congestion, runny nose, itchy nose, or sneezingwill be screened and those meeting the criteria of inclusion will be includedin the study.

•        Spirometry will be performed inpatients presenting with above mentioned complaints. Those showing reversiblechanges (>12% or >200 ml improvement in FEV1) post bronchodilator will bediagnosed as bronchial asthma. Severity will be classified as per the GINA (Global Initativefor Asthma) guidelines. (Table 1)

•        Written informed consent of the patientwill be taken before the procedure and careful history, physical examinationand necessary investigations will be performed.

Table 1: Classificationof 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:

Asoft clip will be placed on the nose of the patients to keep both nostrilsclosed. Patients will be instructed to take a deep breath in, hold it for a fewseconds, and then exhale as hard as patient can into the mouthpiece ofspirometer. The procedure will be repeated three times to record the readingsto make sure the values are consistent. Patients will be then given an inhaledshort acting bronchodilator through nebulizer. The procedure will be repeatedagain after 15 minutes to record another three recordings. Pre and postbronchodilators values will be compared.

•        Increasein FEV1 by >200 ml and >12% from the baseline value after inhaling abronchodilator, will be considered as significant bronchodilator responsivenessor reversibility.

 

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[i] Agnivesha, Charakasamhita, VimanSthana,SrotovimanAdhyaya, 5/7,     Vidyotinihindi commentary by Pt.KashinathaShastri & Dr. GorakhanathaChaturvedi, Part -1, ChaukhambhaBharatiAcademy, Varanasi, 2006; 710.

[ii] Susruta, Susruta Samhita, SharirSthan,DhamnivyakarnaSharir, 9/12,  edited byAyurveda 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, ChaukhambhaBharatiAcademy, Varanasi, 2006; 389.

[iv] Agnivesha, Charakasamhita, ChikitsaSthana, HikkashwasaChikitsa Adhyaya, 17/8-9, Vidyotinihindi commentary by Pt.KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharatiAcademy, Varanasi, 2006.

[v] Agnivesha, Charakasamhita, ChikitsaSthana, HikkashwasaChikitsa Adhyaya, 17/55-62, Vidyotinihindi commentary by Pt.KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharatiAcademy, Varanasi, 2006; 567.

[vi] According to the global initiative forAsthma (GINA)  : O Byrne p. GINAExecutive 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 Heterogeneityin the Prevalence of Asthma among Young Women in India. BMC Pulm Med **20,**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, ChaukhambhaBharatiAcademy, Varanasi, 2006; 525.

[ix] Agnivesha, Charakasamhita, ChikitsaSthana, HikkashwasaChikitsa Adhyaya, 17/121, Vidyotinihindi commentary by Pt. KashinathaShastri&Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharati Academy, Varanasi,2006; 525.

[x] Agnivesha, Charakasamhita, ChikitsaSthana, HikkashwasaChikitsa Adhyaya, 17/122, Vidyotinihindi commentary by Pt.KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharatiAcademy, Varanasi, 2006; 525.

 [x]Weitzman RE, Feng AL,Justicz N, Gadkaree SK, Lindsay RW. Unilateral Nasal Obstruction Causes SymptomSeverity Scores Similar to Bilateral Nasal Obstruction. Facial Plast Surg. 2020Aug;36(4):487-492. doi: 10.1055/s-0040-1714265. Epub 2020 Jul 27.