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CLINICAL RESEARCH
Year : 2015  |  Volume : 36  |  Issue : 3  |  Page : 271-277  

Efficacy of Vasa Avaleha and its granules on Tamaka Shwasa (bronchial asthma): Open-label randomized clinical study


1 Department of Rasa Shastra and Bhaishajya Kalpana, J.S. Ayurveda Mahavidyalaya, Nadiad, Gujarat, India
2 Department of Rasa Shastra and Bhaishajya Kalpana including Drug Research, Institute for Postgraduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India

Date of Web Publication20-May-2016

Correspondence Address:
Ankit M Paneliya
Lecturer, Dept. of RS and BK, J. S. Ayurveda Mahavidyalaya, Nadiad - 387 001, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-8520.182760

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   Abstract 

Introduction: Bronchial asthma is one of the chronic inflammatory disorders of the respiratory tract causing a huge number of deaths annually. Increased industrialization and pollution are the exacerbating factors for this situation. In Ayurveda, this miserable condition is comparable with Tamaka Shwasa. Synthetic drugs provide instant symptomatic relief in cases of bronchial asthma but are known to develop certain adverse drug reactions. Considering this, the current suffering population is looking hopefully towards other systems of medicine such as Ayurveda for better relief. Ayurveda has a number of formulations to treat Tamaka Shwasa and is in practice with proven efficacy. Aims: To evaluate comparative clinical efficacy of Vasa Avaleha (VA) and its granules (GVA) in cases of Tamaka Shwasa. Materials and Methods: A total of 66 patients were registered and randomly grouped into A and B. Patients of Group A were treated with VA, while Group B with GVA at dose of 6 g twice a day with lukewarm water for the duration of 28 days. Follow-up was done after 14 days. The results were assessed in terms of clinical recovery, symptomatic relief, and pulmonary function improvement. Effect of the treatment was assessed based on subjective and objective parameters. Results: Significant improvement was observed in most of the cardinal and associated symptoms. Significant increase in peak expiratory flow rate, considerable decrease in absolute eosinophil count, and increased breath holding time were noticed. Withdrawal of modern emergency drugs, decreased frequency of attacks, improved quality of life were the major observations noticed in both groups. Conclusions: This study highlights the significance of traditional herbal formulations in noncommunicable diseases such as bronchial asthma, which can be used as an effective drug in place or along with modern drugs.

Keywords: Bronchial asthma, noncommunicable disease, Tamaka Shwasa, Vasa Avaleha


How to cite this article:
Paneliya AM, Patgiri B, Galib R, Prajapati PK. Efficacy of Vasa Avaleha and its granules on Tamaka Shwasa (bronchial asthma): Open-label randomized clinical study. AYU 2015;36:271-7

How to cite this URL:
Paneliya AM, Patgiri B, Galib R, Prajapati PK. Efficacy of Vasa Avaleha and its granules on Tamaka Shwasa (bronchial asthma): Open-label randomized clinical study. AYU [serial online] 2015 [cited 2020 Oct 29];36:271-7. Available from: https://www.ayujournal.org/text.asp?2015/36/3/271/182760


   Introduction Top


Asthma is one of the most common chronic diseases. An estimated 300 million people worldwide suffer from asthma, with 250,000 annual deaths attributed to the disease.[1] The prevalence of asthma in different countries varies widely, but the disparity is narrowing due to rising prevalence in low- and middle-income countries and plateauing in high-income countries.[2] Increased rate of its prevalence may be because of changes in life-style, rapid industrialization, increase in air pollution etc. Common risk factors of asthma include exposure to allergens (such as those for work place, house dust, mites, animal fur, cockroaches, pollens, and mold), occupational irritants,[1] tobacco smoke,[3] respiratory infections, food allergies (such as milk, peanuts, and eggs), and psychological stress.[4] During asthma attack, the lining of the bronchial tubes swell, causing the airways to narrow and reducing the flow of air into and out of the lungs causing sleeplessness, daytime fatigue, reduced activity levels and school and work absenteeism.[5] This miserable condition is comparable to Tamaka Shwasa in Ayurveda.

Detailed description of Tamaka Shwasa including pathogenesis, signs and symptoms, and treatment is available in Ayurveda classics.[6] The symptoms of Tamaka Shwasa are Asinolabhate Soukhyam (comfortable in sitting posture), Pratamyati Vegataha (tachypnea), Kasa (cough), Kanthodhwansa (hoarseness of voice), Parshwa Graham (stiffness in flanks), etc., and are similar to the symptoms of bronchial asthma. Although modern system of medicine has their own lines of treatment for this condition, they are known to develop various adverse reactions. Observing all these, the scenario is hopefully looking toward traditional systems of medicine such as Ayurveda for better answers.

Vasa Avaleha (VA) is herbal formulation used commonly in the treatment of various diseases of respiratory system.[7] In the current study, it has been planned to evaluate comparative clinical efficacy of VA and its granules (GVA) in Tamaka Shwasa.


   Materials And Methods Top


Patients of both sex, between the age of 12 and 70 years with mild persistent cases of bronchial asthma, were registered in the trial from outdoor and indoor patient department IPGT and RA Hospital, Jamnagar. The study obtained Institutional Ethics Committee clearance (PGT/7-A/2012-2013/1964/22 dated 21/09/2012) and registered at Clinical Trial Registry of India (CTRI/2012/12/003184). A written informed consent from each patient was taken before enrolling in the clinical trial.

Exclusion criteria

Dyspnea resulting from other diseases such as left ventricular failure, chronic obstructive pulmonary disease (chronic bronchitis, emphysema), upper respiratory tract obstruction, patients with anemia, pneumonia, tuberculosis, lung cancer, lung abscess, and other such complicated conditions were excluded from the study.

Investigations

Routine hematological, especially white blood cell, erythrocyte sedimentation rate, absolute eosinophil count (AEC), and urine examination were carried out in all the patients. Biochemical investigations such as random blood sugar, serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase, and chest X-ray were carried out as per the need to exclude other pathologies. Breath holding time (BHT) and peak expiratory flow rate (PEFR) were also recorded in all the patients before and after treatment.

Diet and restrictions

Patients were advised to avoid cause and aggravating factors such as curd, cold drinks, fish and meat, tobacco chewing and smoking, alcohol, excessive physical work, day sleep, and exposure to dust, smoke, pets, and pollens. Patients were advised to use lukewarm water after meal and at bed time. They were also advised for light diet, breathing exercises such as Pranayama, use of mask while working, to avoid exposure to dust and smoke, etc.

Trial drugs

The raw material was procured from Pharmacy, Gujarat Ayurved University, Jamnagar and authenticated in the Pharmacognosy Laboratory, IPGT and RA, Jamnagar. Both trial drugs were prepared in the Department of Rasashastra and Bhaishajya Kalpana, IPGT and RA, Jamnagar by following classical guidelines. Formulation composition of both trial drugs that is VA and GVA is shown in [Table 1].
Table 1: Formulation composition of Vasa Avaleha and Granules of Vasa Avaleha

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Grouping and posology

A total of 66 patients were randomly grouped into A and B using computer generated randomization [Chart 1 [Additional file 1]], Group A (n = 32) received VA, while Group B (n = 34) received GVA at dose of 6 g twice a day with lukewarm water in the morning and evening for the duration of 28 days. Follow-up period was 14 days in both groups.

Criteria for assessment

Efficacy of the trial drugs was analyzed by specific grading pattern including asthma control questionnaire (ACQ) and asthma control test (ACT)[8],[9],[10] in terms of relief observed in cardinal signs and symptoms before and after treatment. Changes in PEFR, BHT, and AEC were also considered in evaluating comparative efficacy of the trial drugs.

Statistical analysis

Obtained data were statistically analyzed using Wilcoxon signed rank test, Paired t-test, Unpaired t-test, and Chi-square test.


   Observations And Results Top


It was observed that 51.51% patients were of Vata-Kapha Prakriti followed by Vata-Pitta Prakriti (30.30%) and Pitta-Kapha Prakriti (18.18%). About 7.57% of patients registered in the study were addicted to tobacco smoking. Chronicity of 1–5 years duration was reported in 33.33% patients.

Effect of therapy on cardinal symptoms

Statistically highly significant results were observed in all the cardinal symptoms. Group A showed better improvement than Group B in breathlessness, frequency and intensity of attack and cough whereas in Group B, better effect on duration of attack, wheezing, tachypnea and night symptoms was found [Table 2]. The difference between the groups was statistically insignificant [Table 3].
Table 2: Effect of Vasa Avaleha and Granules of Vasa Avaleha on chief complaints

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Table 3: Effect of test drugs Group A on chief complaints in comparison to Group B

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Effect of therapy on associated symptoms

Effect of both trail drugs on associated symptoms was also highly significant except dryness of oral cavity in Group B [Table 4].
Table 4: Effect of Vasa Avaleha and Granules of Vasa Avaleha drugs on associated symptoms

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Effect of therapy on objective parameters

Effect of both trail drugs on objective parameters such as need of any reliever, BHT, and PEFR was statistically highly significant [Table 5]. ACT showed highly significant results in both groups whereas ACQ showed significant results in both groups [Table 6].
Table 5: Effect of Vasa Avaleha and granules of Vasa Avaleha on objective criteria

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Table 6: Effect of Vasa Avaleha and granules of Vasa Avaleha on asthma control test and asthma control questionnaire

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Overall effect of therapy

Complete remission was not found with any of the drugs. At the end of treatment, moderate improvement was found in 25.93% patients in Group A while 32.26% in Group B; mild improvement was found in 66.67% in Group A while 64.52% in Group B.


   Discussion Top


Ayurveda emphasizes on Srotorodha (obstruction of channels) in the manifestation of Shwasa Roga, which is the resultant of disturbance in the equilibrium of Vata and Kapha. Hence, drugs that are beneficial in removing the obstruction and maintain the physiological equilibrium of Vata and Kapha are useful in pacifying Tamaka Shwasa. Acharyas have also provided specific guidelines in the management of Tamaka Shwasa with drugs having Vata-Kapha Hara, Ushna, and Vatanulomana properties.[11]

VA, an herbal formulation indicated in respiratory diseases, acts on the disease by Vata-Kaphaghna property. Sukshma and Tikshna Guna of Vasa (Adhatoda vasica Nees.), Pippali (Piper longum Linn.), Madhu (honey) help in Kaphanihsarana and remove Upalepa of Kapha in Kantha (throat) and Ura (chest). Vatahara drugs such as Sita, Go-Ghrita (cow ghee), Pippali cause Vatanulomana and passify Vimarga Kupita Vata caused due to Vimargagami Prana and Apana Vayu. Go-Ghrita, Pippali also act on Pitta Sthana improving the function of Agni thus normalizing Vatakarma. This process sets right the digestion, assimilation, and metabolism. Further, Go-Ghrita[12] and Pippali help in improving immunity of the body with their Rasayana (rejuvinative) effect, thus preventing the recurrences of symptoms.

Vasa, a major component of VA, is indicated in diseases such as Shwasa, Rajayakshma (tuberculosis), Raktapitta, Shotha (edema), and Jwara (fever).[13] Vasicine and vasicinone, the bitter alkaloids available in the plant, has bronco-dilatory effect. Few studies have proven 6–10 times greater efficacy of vasicinone against aminophylline in cases of bronchial asthma.[14]

Pippali enhances bioavailability,[15] which helps in maintaining the major therapeutic principles in the systemic circulation for longer duration that is responsible for the anti-asthmatic activity of the formulation.

Statistically highly significant (P < 0.001) results were obtained in both groups on cardinal symptoms such as breathlessness, paroxysm of breathlessness, intensity of the attack, frequency of attack, cough, nasal symptoms, pain in ribs, night symptoms, and immediate relief after expectoration. However, the percentage change was more in Group A. Whereas in symptoms such as duration of attack, wheezing, tachypnea and night symptoms, more percentage change was found in Group B. Statistically insignificant difference was found on cardinal symptoms and vital parameters in between the groups.

Effect of both trail drugs shows highly significant result in comfort in sitting and desire on warmness. Significant result was observed in sweating on forehead and dryness in oral cavity (Group A), whereas in Group B, insignificant result was observed in dryness of oral cavity.

The usage of trial drugs, the duration, frequency, and dosage of the emergency allopathic medicines including steroids were significantly reduced and in few cases, they were withdrawn. Vital parameters in both groups treated patients shown highly significant reduction in respiratory rate and highly significant increase was found in BHT and PEFR. Effect of therapy on ACT and ACQ shows highly significant results in both treated groups. Most of the patients in their follow-up too did not felt the need of any emergency medication.


   Conclusions Top


The current study revealed that both trial drugs are effective in the treatment of Tamaka Shwasa without manifesting any adverse reactions. Use of modern medicines was also curtailed or withdrawn during the treatment with increased quality of life. Hence, safety can be added as a couplet to the conventional anti-asthmatic drugs.

Financial support and sponsorship

IPGT & RA, GAU, Jamnagar, Gujarat.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
World Health Organization. Global Surveillance, Prevention and Control of Chronic Respiratory Diseases: A Comprehensive Approach; 2007. Available from: target="_blank" href aaaai/newsroom/asthma-statistics.aspx. [Last accessed on 2014 Apr 10].  Back to cited text no. 1
    
2.
World Allergy Organization (WAO) White Book on Allergy; 2011. Available from: target="_blank" href="http://" target="_blank" href="www.aaaai.org/about-theaaaai/newsroom/asthma-statistics.aspx". [Last accessed on 2014 Apr 10].  Back to cited text no. 2
    
3.
Jindal SK, Gupta D. The relationship between tobacco smoke and bronchial asthma. Indian J Med Res 2004;120:443-53.  Back to cited text no. 3
    
4.
Chen E, Miller GE. Stress and inflammation in exacerbations of asthma. Brain Behav Immun 2007;21:993-9.  Back to cited text no. 4
    
5.
World Health Organization. Signs and Symptoms of Asthma; 2008. Available from: target="_blank" href="http://"www.who.int/respiratory/asthma/en/. [Last accessed on 2014 Apr 10].  Back to cited text no. 5
    
6.
Acharya YT, editor. Charaka Samhitha of Agnivesha, Chikitsa Sthana. Reprint Edition. Ch. 17, Ver. 55-66. Varanasi: Chaukhamba Surbharati Prakashana; 2011. p. 535.  Back to cited text no. 6
    
7.
Mishra SN, editor. Bhaishajya Ratnavali of Govind Das Sen. 20th ed.., Ch. 14, Ver. 37-39. Varanasi: Chaukhambha Surbharti Prakashan; 2011. p. 408.  Back to cited text no. 7
    
8.
Yadav SS, Galib R, Patgiri B, Prajapati PK. Clinical efficacy of two different samples of Shirishavaleha in Tamaka Shwasa (Bronchial Asthma). Ayu 2012;33:255-60.  Back to cited text no. 8
[PUBMED]  Medknow Journal  
9.
Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J 1999;14:902-7.  Back to cited text no. 9
    
10.
Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, et al. Development of the asthma control test: A survey for assessing asthma control. J Allergy Clin Immunol 2004;113:59-65.  Back to cited text no. 10
    
11.
Acharya YT, editor. Charaka Samhitha of Agnivesha, Chikitsa Sthana. Reprint Edition. Ch. 17, Ver. 147. Varanasi: Chaukhamba Surbharati Prakashana; 2011. p. 539.  Back to cited text no. 11
    
12.
Acharya YT, editor. Charaka Samhitha of Agnivesha, Sutra Sthana. Reprint Edition. Ch. 13, Ver. 14. Varanasi: Chaukhamba Surbharati Prakashana; 2011. p. 82.  Back to cited text no. 12
    
13.
Sharma PV. Dravyaguna Vijnana (Hindi). Vol. 2. Varanasi: Chaukhambha Bharti Academy; 2006. p. 242.  Back to cited text no. 13
    
14.
Atal CK. Chemistry and Pharmacology of Vasicine: A New Oxytocic and Abortifacient. Jammu: Regional Research Laboratory; 1980. p. 49.  Back to cited text no. 14
    
15.
Dev S. “Approaches to Herbal Drug Research”, Ranbaxy Science Foundation, 7th Round Table Conference; 2006. p. 80.  Back to cited text no. 15
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]


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