Effect of Ayurveda treatment in the Management of Tamaka Shwasa(Bronchial Asthma)
- Conditions
- Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH,
- Registration Number
- CTRI/2022/07/044267
- Lead Sponsor
- National Institute of Ayurveda
- Brief Summary
Introduction:*Shwasa* *Ro*gainAyurveda is described as apresenting feature of *Pranvahasrotodusti.* *Acharya Charaka* hasdescribed *Hridaya* and *Mahasrotasa[**[i]**](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn1)*whereas *Acharaya Sushruta*considered *Hridaya* and *Rasavahini* *Dhamanyaha* as the *Mool* of *Pranvahasrotasa*.[[ii]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn2)*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]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn3)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]**](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn4)*Obstruction in the *Pranavaha* *Srotas* due to accumulation of *Kapha**Dosha* causes vitiation of *Vayu*which further attains *Pratilomgati* to create the pathogenesis of *TamakShwasa Roga*.[[v]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn5) *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]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn6) 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]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn7)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 *Shwasa*according to Ayurveda.
*Charak* hasgiven following guidelines for the treatment of *Shwasa*:-
यतà¥à¤•à¤¿à¤žà¥à¤šà¤¿à¤¤à¥ कफवातघà¥à¤¨à¤®à¥à¤·à¥à¤£à¤‚ वातानà¥à¤²à¥‹à¤®à¤¨à¤®à¥| à¤à¥‡à¤·à¤œà¤‚ पानमतà¥à¤°à¤‚ वा तदà¥à¤§à¤¿à¤¤à¤‚ शà¥à¤µà¤¾à¤¸à¤¹à¤¿à¤•à¥à¤•à¤¿à¤¨à¥‡|| (Ch.chi.17/147)[[viii]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn8)
वातशà¥à¤²à¥‡à¤·à¥à¤®à¤¹à¤°à¥ˆà¤°à¥à¤¯à¥à¤•à¥à¤¤à¤‚ तमके तॠविरेचनमà¥|| (Ch.chi.17/121)[[ix]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn9)
उदीरà¥à¤¯à¤¤à¥‡ à¤à¥ƒà¤¶à¤¤à¤°à¤‚ मारà¥à¤—रोधादà¥à¤µà¤¹à¤œà¥à¤œà¤²à¤®à¥| यथा तथाऽनिलसà¥à¤¤à¤¸à¥à¤¯ मारà¥à¤—ं नितà¥à¤¯à¤‚ विशोधयेतà¥|| (Ch.chi.17/122)[[x]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_edn10)
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* having*Kapha-Vata* shamak and *Ushna*properties and *Eranda Bhrista Haritaki* having *Vatanuloman* and*Nitya 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 haritaki*in *Tamaka Shwasa*(Bronchial Asthma).
**Objective:**
• 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**â€* 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 V*irechana 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]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref1) Agnivesha, Charakasamhita, VimanSthana,SrotovimanAdhyaya, 5/7, Vidyotinihindi commentary by Pt.KashinathaShastri & Dr. GorakhanathaChaturvedi, Part -1, ChaukhambhaBharatiAcademy, Varanasi, 2006; 710.
[[ii]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref2) Susruta, Susruta Samhita, SharirSthan,DhamnivyakarnaSharir, 9/12, edited byAyurveda TattvaSandipika, Commentary by KavirajaAmbikaduttaShastri,Part-1,Chaukhambha Sanskrit Sansthan, Varanasi, 2009; 96.
[[iii]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref3) Agnivesha, Charakasamhita, SutraSthana,AshtoudariyaAdhyaya, 19/4, Vidyotinihindi commentary by Pt.KashinathaShastri& Dr. GorakhanathaChaturvedi, Part -1, ChaukhambhaBharatiAcademy, Varanasi, 2006; 389.
[[iv]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref4) Agnivesha, Charakasamhita, ChikitsaSthana, HikkashwasaChikitsa Adhyaya, 17/8-9, Vidyotinihindi commentary by Pt.KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharatiAcademy, Varanasi, 2006.
[[v]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref5) Agnivesha, Charakasamhita, ChikitsaSthana, HikkashwasaChikitsa Adhyaya, 17/55-62, Vidyotinihindi commentary by Pt.KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharatiAcademy, Varanasi, 2006; 567.
[[vi]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref6) 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]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref7) 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]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref8)Agnivesha, Charakasamhita, ChikitsaSthana,Hikkashwasa Chikitsa Adhyaya, 17/147, Vidyotinihindi commentary by Pt.KashinathaShastri& Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharatiAcademy, Varanasi, 2006; 525.
[[ix]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref9) Agnivesha, Charakasamhita, ChikitsaSthana, HikkashwasaChikitsa Adhyaya, 17/121, Vidyotinihindi commentary by Pt. KashinathaShastri&Dr. Gorakhanatha Chaturvedi, Part -2, ChaukhambhaBharati Academy, Varanasi,2006; 525.
[[x]](file:///C:/Users/dell/Desktop/Rahul/rahul%20asthma%20synopsis%20(2).docx#_ednref10) 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
- •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.
- •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Forced Expiratory Volume in first second (FEV1) from baseline values. 56 days
- Secondary Outcome Measures
Name Time Method •Improvement in Peak expiratory flow rate (PEFR). •Changes in IgE & Absolute Eosinophil count
Trial Locations
- Locations (1)
National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Ayurveda🇮🇳Jaipur, RAJASTHAN, IndiaRahul Kumar DuchaneyaPrincipal investigator8769834903rahulkumarpinkcity@gmail.com