|Year : 2014 | Volume
| Issue : 4 | Page : 384-390
Comparative clinical efficacy of Ashtangavaleha and Vyaghreehareetakee Avaleha on Tamaka Shwasa (bronchial asthma) in children
Arvind Kumar Dubey1, S Rajagopala2, Kalpana S Patel2
1 Department of Kaumarbhritya, JD Ayurvedic Medical College and Hospital, Aligarh, Uttar Pradesh, India
2 Department of Kaumarbhritya, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India
|Date of Web Publication||18-Jun-2015|
Arvind Kumar Dubey
Asst. Prof., Department of Kaumarbhritya, JD Ayurvedic Medical College and Hospital, Bhankari, G. T. Road, Aligarh - 202 001, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Clinical trial registration CTRI/2011/10/002059
| Abstract|| |
Background: Tamaka Shwasa is a chronic inflammatory condition of the lung airways resulting in episodic airflow obstruction. This disease is more predominant in children and aged population. Apart from being the leading cause of hospitalization for children, it is one of the most important chronic conditions causing elementary school absenteeism. The parallel disease entity in contemporary medical science to this disorder is Bronchial Asthma. Aim: This study was aimed to evaluate the clinical efficacy of Ashtangavaleha and Vyaghreehareetakee Avaleha on Tamaka Shwasa (Bronchial Asthma) in Children. Materials and Methods: The study was therapeutic interventional randomized clinical trial. Totally 100 patients suffering from Tamaka Shwasa were selected, and 74 patients completed the course of treatment. Patients were divided into two groups. Ashtangavaleha was administered in group AG and Vyaghreehareetakee Avaleha was administerd in group VG (5-15g in divided doses) for 8 weeks duration. Comaprative assesment of both the drugs was done on the signs and symptoms of the disease, pulmonary function test and quality of life parameters. Results: When the individualized overall effect of therapy was considered, more number of patients treated with Ashtangavaleha reached moderate improvement zone than the patients treated with Vyaghreehareetakee Avaleha. Conclusions : The trial showed a marginal better efficacy of Ashtangavaleha (66.66%) in comparison to Vyaghreehareetakee Avaleha (63.15%) on the overall condition of the patients even though the superiority was statistically insignificant (>0.05).
Keywords: Ashtangavaleha, bronchial asthma, randomized clinical trial, Tamaka Shwasa, Vyaghreehareetakee Avaleha
|How to cite this article:|
Dubey AK, Rajagopala S, Patel KS. Comparative clinical efficacy of Ashtangavaleha and Vyaghreehareetakee Avaleha on Tamaka Shwasa (bronchial asthma) in children. AYU 2014;35:384-90
|How to cite this URL:|
Dubey AK, Rajagopala S, Patel KS. Comparative clinical efficacy of Ashtangavaleha and Vyaghreehareetakee Avaleha on Tamaka Shwasa (bronchial asthma) in children. AYU [serial online] 2014 [cited 2020 Feb 23];35:384-90. Available from: http://www.ayujournal.org/text.asp?2014/35/4/384/158995
| Introduction|| |
Ayurveda descried five types of Shwasa Roga (pathological conditions concerned with difficulty in breathing and associated clinical conditions) and among these, Tamaka Shwasa is one. , Tamaka Shwasa is a "Swantarta0" Vyadhi, that is, independent disease entity and having its own etiology, pathophysiology, and management. It is mentioned as Yapya Vyadhi, that is, a disease of the chronic nature and difficult to cure.  Tamaka Shwasa is basically a disorder of Pranavaha Srotas while other Srotas are also vitiated.  The parallel disease entity in contemporary medical science to this disorder is Bronchial Asthma. Bronchial Asthma is a chronic inflammatory condition of the lung airways resulting in episodic airflow obstruction. 
The prevalence of Bronchial Asthma has increased continuously since the 1970s, and now affects an estimated 4-7% of the people worldwide.  There has been an increase in the prevalence, and a similar trend is observed in India. Asthma prevalence rates in Karnataka, Gujarat, Haryana, Uttar Pradesh, and Madhya Pradesh are above the national level.  This disease is more predominant in children and aged population. At the age of 6-7 years, the prevalence ranges from 4% to 32%. Apart from being the leading cause of hospitalization for children, it is one of the most important chronic conditions causing elementary school absenteeism. ,
Despite advancements in the understanding of asthma and the development of new therapeutic strategies, the morbidity and mortality rates due to asthma have increased.  Prognosis is poor if asthma develops in younger age. On the management side, chemotherapy is effective in controlling the severity of attacks and prevents the episodes, but, no disease-modifying effect of chemotherapy is present after the treatment is discontinued. 
Though environmental control measures are important to avoid or eliminate factors that induce or trigger asthma flare-ups; various formulations such as Ashtangavaleha,  Vyaghreehareetakee Avaleha,  Shireesha Avaleha, etc., are available in Ayurvedic classics to manage the condition. The present study is aimed to compare the efficacy of Ashtangavaleha (AG) and Vyaghreehareetakee Avaleha (VG) on Tamaka Shwasa in children.
| Materials and Methods|| |
Children with clinical features of Tamaka Shwasa with the age limit of 2-16 years of either sex were the research population of the study. The subjects were selected as per the selection criteria from Out Door Patient Department of Kaumarbhritya, IPGT and RA, Gujarat Ayurved University, Jamnagar.
The clinical trial was carried out after obtaining Institutional Ethics Committee (IEC) clearance (PGT/7-A/Ethics/2010-2011/3381 dated. 07/10.01.2011). The trial was registered in Clinical Trial Registry-India (CTRI/2011/10/002059-Trial registered retrospectively). It is a therapeutic, interventional, randomized clinical trial. Computer generated randomization  method was used for generating randomization sequence (seed 22412) and an open trial design was followed. Randomization plan was created on Wednesday March 23 2011 11:40:22 GMT + 0530 (India Standard Time). 100 subjects were randomized into 2 blocks.
- Diagnosed cases of Tamaka Shwasa - Bronchial Asthma with at least 3 episodes of asthma symptoms (cough, breathlessness) during the previous year
- Severity as mild to moderate stable asthma defined by Forced Expiratory Volume in 1 s (FEV 1 ) >60% and <80% of that predicted by Polgar equation
- Able to generate a peek inspiratory flow rate of 60 L/min 
- Patients on other drug therapy will be included only after completion of the wash out period prescribed.
- Evidence of active concomitants pulmonary disease other than asthma
- Evidence of requirement of intubations for asthma, or had been hospitalized for asthma within 1-month before. Had unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 3 weeks
- More than 4 short courses of oral corticosteroids within the year preceding the screening visit or any oral corticosteroids in the preceding 4 weeks. Use of astemizole, nedocromil, cromolyn, long acting β agonists, ketotifen, or theophylline within 2 weeks before
- Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological).
Grouping and posology
- Group I (Intervention agent): Ashtangavaleha (AG)
- Group II (Comparator agents) : Vyaghreehareetakee Avaleha (VG).
The dose of drug administration was calculated based on Sharngadhara Samhita's dose fixation guidelines.  The dose was 5-15 g for both groups depending on the age. In 2-4 years of age group, the dose was 3 g while it was 6 g in 5-7 years, 9 g in 8-10 years, 12 g in 11-13 years and 15 g in Above 13 years age group. The drug was advised to administer in two divided doses Pragbhakta (before food) in morning and evening with luke warm water orally. Both the test drugs were procured from Pharmacy, Gujarat Ayurved University, Jamnagar.
- Complete hemogram and total eosinophils count
- Serum IgE
- Pulmonary function tests by spirometry and peak expiratory flow (PEF) meter
- Urine examination - routine and microscopic
- Stool examination - routine and microscopic (in suspected cases of worm infestation only).
The assessment was based on the following parameters.
I Improvement in signs and symptoms of Tamaka Shwasa vis-a-vis Bronchial Asthma.
- Shwasakashtata (breathlessness)-(MRC dyspnoea scale) 
- Not troubled by breathlessness except on
strenuous exercise 1
- Short of breath when hurrying or walking up
a slight hill 2
- Walks slower than contemporaries on level
ground because of breathlessness or have to
stop for breath when walking at own pace 3
- Stops for breath after walking about
100 meters or after a few minutes on level ground 4
- Too breathless to leave the house or breathless
when dressing or undressing 5
- Frequency of Shwasa Vega
- No attack during one month 0
- Frequency of attack once in a month 1
- Frequency of attack once in two weeks 2
- Frequency of attack once in a week 3
- Frequency of attack twice in a week 4
- Frequency of attack once or more than once
in a day 5
- Ghurghurakam (wheezing)
- No wheezing 0
- Wheezing during attack 1
- Very often wheezing 2
- Always wheezing found 3
- Kasa (cough)
- No Kasa 0
- Kasa Vega sometimes but not troublesome 1
- Troublesome Kasa, but does not disturbing the sleep 2
- Very troublesome Kasa, does not even allowing to sleep at night 3
- No Kaphastheevan 0
- Occasional Kaphastheevan 1
- Very often Kaphastheevan 2
- Always Kaphastheevan 3
- Parshvashula (chest pain)
- No pain 0
- Pain on exertion 1
- Pain on cough 2
- Pain during attack 3
- Persistent pain 4
- Peenasa (coryza)
- No Peenasa 0
- Peenasa along with attack 1
- Peenasa even without attack 2
- Peenasa persisting 3
- Na Chapi Nidram Labhate (night symptoms)
- No night symptoms 0
- Sleep disturbed because of slight breathlessness 1
- Awekening because of breathlessness 2
- No sleep difficulty of breathlessness whole night 3
- Kanthodhvamsa (irritation in throat)
- No Kanthodhvamsa 0
- Occasional Kanthodhvamsa 1
- Very often Kanthodhvamsa 2
- Always Kanthodhvamsa 3
- Krichchhrabhashitam (difficulty in speaking)
- No difficulty in speaking 0
- Difficulty in speaking during attack 1
- Difficulty continuous soon after attack 2
- Difficulty continuous for more time 3
II Improvement in pulmonary function tests parameters
III Improvement in frequency and severity in daytime asthma symptoms, overnight asthma symptoms (cough, wheezing, trouble breathing, and activity limitation)
IV Global Initiative for Asthma (GINA) level of asthma control,  Asthma control test (ACT),  Asthma control questioner ACQ. 
- Positive changes in the blood picture
- Reduction in Eosinophils count
- Improvements in IgE antibody levels in serum.
Both groups were assessed before and after the treatment period.
Assessment of total effect of therapy
The improvement in quality of life (QOL parameters)  were considered in all the below mentioned categories for final assessment.
- Improved: 100% relief of signs and symptoms
- Markedly improved: Improvement between >75% and 99%
- Moderately improved: Improvement between >50% and 75%
- Mild improvement: Improvement between 25% and 50%
- Unchanged: No relief in signs and symptoms.
Peak Flow Meter and Spirometry was carried out to those who can perform the test to explore the condition. The follow-up period was of 8 weeks, with fortnight intervals of patient visit for any recurrence of symptoms of Tamaka Shwasa.
Comparative efficacy in group AG and VG was assessed by applying the unpaired Student's t-test.
| Observations|| |
Total 74 patients completed the course of treatment. In group Ashtangavaleha (AG), 36 patients while in group Vyaghreehareetakee Avaleha (VG), 38 patients completed the course of treatment.
In general obcservations out of 100, maximum number of patients that is 27% belonged to 5-7 years age group, 71% male, 87% of Hindu religion, 48% were from middle group of socioeconomic status. In chief complaints Shwaskashtata (breathlessness), Kasa (cough) and Peenas was noted in 100% patient. Ghurghurakam (audible breathing) was complained by 90% patients, expectoration was noted in 70% of patients, 64% patients reported disturbed sleep and Urah-Parshwa Peeda (chest pain/chest tightness). Chronicity of Tamaka Shwasa (1-5 years) was noted in 65% of patients, family history of asthma was reported in 69% patients.
| Results|| |
Effect on cardinal symptoms of Tamaka Shwasa
The variations in the effects of Ashtangavaleha and Vyaghreehareetakee Avaleha on the symptoms of Tamaka Shwaasa were statistically insignificant except in cough in which the comparator agent showed better result, which was statistically significant [Table 1].
The variations in the effects of intervention and comparator agents on Asthma Control Questioner (ACQ) assessments were statistically insignificant except in awakening in night due to asthma (<0.05), level of asthma control (<0.001) and asthma control test (ACT) score (<0.05) in which the intervention agents showed better result, which was statistically significant [Table 2].
Effect on hematological parameters
On hematological parameters, group AG showed an increase of total white blood cells, eosinophil, differences in the effects of trial and control drugs on the on the hematological parameters were statistically insignificant except TRBC. On biomarker, both the groups showed an increase in the serum levels of IgE and it was more in group VG, but comparative difference between group AG and group VG was statistically insignificant [Table 3].
Effect on pulmonary function test
Peak flow meter test
Both PEF and FEV 1 were increased in both groups, and it was more in group AG, but the comparative effect between group AG and group VG were statistically insignificant [Table 4].
An increase was observed in FEV 1 , FVC and PEF parameters in both the groups. Increase in FEV 1 , FVC and PEF observed in group AG is greater than group VG, but the difference found is statistically insignificant. FEV 1 /FVC% was increased in group VG while it was decreased in group AG and comparative difference within the groups was found statistically significant [Table 5].
Effect on quality of life
Quality of life was assessed on general, physical, psychological and environmental health parameters. In the domain of general health, both groups showed highly significant results but group AG (42.4%) showed better results than group VG (39.0%) while difference was statistically insignificant. In the domain of physical health, both groups showed highly significant results but group AG (36.2%) showed better results than group VG (35.10%) while difference was statistically insignificant. In the domain of psychological health, both groups showed highly significant results but group AG (42.7%) showed better results than group VG (38.7%) while difference was statistically insignificant. In the domain of social health, both groups showed highly significant results but group AG (41.8%) showed better results than group VG (36.4%) while difference was statistically insignificant. In the domain of environmental health both groups showed highly significant results but group AG (28.6%) showed better results than group VG (24.68%) while difference was statistically insignificant. All the QoL parameters were increased in both groups and group AG showed better results than group VG. While comparing between the group AG and group VG, difference was statistically insignificant [Table 6].
Overall effect of therapy
When the individualized overall effect of therapy were considered more number of patients in group AG reached moderate improvement zone when compared with group VG. In marked improvement zone, group AG had more number of patients while in mild improvement zone, group VG had more number of patients [Table 7]. In group AG, overall improvement was 66.66% whereas in group VG, it was 63.15%. While comparing between group AG and VG, the differences was statistically insignificant [Table 8].
| Discussion|| |
On Shwasakashtata (breathlessness), frequency of Shwasa Vega, Ghurghurakam (wheezing), Parshvashoola (chest pain/tightness), Kaphanishtheevana (expectoration of thick phlegm), Shleshma Vimokshante Muhurtam Labhate Shukham (getting relief after expectoration of thick phlegm), Peenasa (coryza), Na Chaapi Nidraam Labhate (night symptoms), Kanthodhvamsa (irritation in throat) and Krichchhrabhashita (difficulty in speaking) both intervention agent Ashtangavaleha and the comparator agent Vyaghreehareetakee Avaleha showed better results but while comparing between the groups, the difference was insignificant. Thus, changes made were similar in both the groups. In both the groups, Kasa (coughing) was decreased Vyaghreehareetakee Avaleha showed better results. The ingredients of Vyaghreehareetakee Avaleha act as local counter irritants and block the efferent fibers of the vagus which carry the cough stimuli to the cough center.  On the comparison between the groups, the difference was significant (<0.01). Thus, Vyaghreehareetakee Avaleha was found more effective in reducing Kasa than Ashtangaavaleha.
Ashtangavaleha showed promising effect than Vyaghreeharetakee Avaleha on ACT score. On ACQ assessments, Ashtangavaleha showed better results on awakening in night, awakening at morning due to asthma, limitation of activities, shortness of breathing, wheeze, need of bronchodilator, in comparison to Vyaghreehareetakee Avaleha. On total ACQ, changes made by both groups were statistically highly significant but on comparison between groups, the changes made by both formulations were similar and statistically insignificant by P > 0.05. Thus, both formulations have a similar effect on total ACQ. The ingredients of both Ashtangavaleha and Vyaghreehareetakee Avaleha have immunomodulatory activity, which helps in regulating the allergic responses.  Immunostimulatory activity of aqueous extract of Kantakari fruits on mice gives strong evidence that the plant is an immunostimulating agent. 
On hematological parameters, decrease in absolute eosinophil count (AEC) shows a decrease in the magnitude of allergy. Here comparator agent showed better efficacy, so it may be inferred that it is more effective in allergic conditions, but the difference is statistically insignificant. Decrease in erythrocyte sedimentation rate simultaneous decrease in AEC clearly indicates the drugs action on allergic conditions.
In group AG and the change was statistically highly significant by P < 0.001. Similarly in group VG, there was 13.04% increase in PEF and 22.49% in FEV 1 and change was statistically highly significant by P < 0.001. On the comparison between the groups, difference was statistically insignificant showed similar effect by both formulations. Thus, both formulations were equally effective on peak flow meter measurements and helpful in managing the severity.
On Spirometry, in group AG and changes were statistically insignificant while, in group VG, changes observed were statistically significant (P < 0.05). Comparative changes between group AG and group VG on FEV 1 and PEF were statistically insignificant. Thus, both formulations have similar effect. A reduced ratio of FEV 1 /forced vital capacity (FVC) indicates obstruction to the flow of air from the lungs. In present trial, FEV 1 /FVC% was increased in group VG. Thus, Vyaghreehareetakee showed superiority over Ashtangavaleha on this parameter.
Quality of life is a key health indicator that should be routinely assessed. For children, it is important to obtain data on disorders that have an impact on the child and place a burden on the family. The QoL was assessed on general, physical, psychological, social and environmental health parameters. In the domain of all the parameters, both groups showed highly significant results but group AG showed better results than group VG while difference was statistically insignificant. In this study, both agents were highly effective in improving QoL. The formulations were having qualities to increases the Bala (strength) which is usually decreased in this condition thus improving the QoL of the child. Due to bio availability enhancer and immunomodulatory activity, the formulations have therapeutic potential for the prevention of allergic diseases. Due to effort made by researcher to educate patient and parents about preservation of the environment, healthy life-style and about exposure to risk factors (concept of Nidana Parivarjana), all the parameters of QoL improved significantly in both groups. Thus, all the QoL parameters assessed were improved significantly in both groups, and group AG showed better results than group VG. While comparing between the group AG and VG, difference was statistically insignificant. These profiles indicate that Tamaka Shwasa significantly reduces the QoL in the patients. The investigator concluded that patients with bronchial asthma express overall lower levels of QoL.
When the individualized overall effect of therapy was considered, more number of patients in group AG reached moderate improvement zone when compared with group VG. In marked improvement zone, group AG had more number of patients while in mild improvement zone group VG had more number of patients. No patient had complete relief in any group. In no improvement zone both the groups are at par.
This shows a marginal better efficacy of Ashtangavaleha in comparison to Vyaghreehareetakee Avaleha on the overall condition of the patients presenting with Tamaka Shwasa. There was 66.66% of relief in the overall condition of Tamaka Shwasa found in group AG and it was 63.15% in group VG. Tamak Shwasa is a multifactorial disorder. The medication that brings Kaphavilayana, Kaphanissarana, Srotomardavata, Kaasaghna, Vatahara, Kaphahara and Brumhana effects will be the best in combating the symptoms of Tamaka Shwasa. Selected drugs are having Kapha-Vata mitigating action Ushnaveerya and Vatanulomana properties. These are having properties to remove the obstruction made by Kapha in the Pranavaha Srotas and related system and normalize the functioning of Vayu. By virtue of Rasayana (immunomodulatory) properties of drugs, they regularize the Dhatwagni and promote the normal condition of the child.
| Conclusion|| |
Above findings inferred that the test drug Ashtangavaleha is marginally more effective in comparison to Vyaghreehareetakee Avaleha in the management of Tamaka Shwasa in children even though the superiority was statistically insignificant (>0.05).
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]