A Clinical study to Evaluate the effect of Virechana karma on Interleukin(Inflammatory markers) in Tamaka shwasa(Bronchial asthma) A Single Arm Study.

A respiratory disorder, usually characterized by variable airflow limitation associated with airway inflammation and remodelling. Bronchial asthma is a chronic inflammatory disease of the airways. Tamaka Shwasa is nearer to bronchial asthma identified with airway obstruction, inflammation, producing extra mucus making it difficult to breath.The prevalence of bronchial asthma is increasingly alarming now a days due to increased air pollution, overcrowding, occupational conditions, stress and poor hygiene. Current Global Initiative for Asthma (GINA) guidelines reported that the prevalence is estimated to be 1 % to 18%. Studies have explored the potential role of indoor and outdoor allergens, microbial exposure, seasonal changes, diet, vitamins, breastfeeding, tobacco smoke, air pollution and obesity but no clear consensus has emerged. As per WHO 2019 health reports about 262 million people are suffering from bronchial asthma.Annually 250000 deaths are attributed to asthma and its complications. It is estimated that there may be an additional 100 million persons with asthma, by 2025. It estimated that the prevalence of asthma in India is about 3% (30 million patients), with a prevalence of 2.4% in adults aged >15 years and between 4% and 20% in children. The current therapies used to treat Bronchial asthma are Corticosteroids, Anti-histamines and bronchodilators.These medications are similar in their adverse effect profile. Nervousness, Tachycardia, Palpitations, difficulty in sleeping are common adverse effects of all these agents. Long-term treatment with these drugs may produce serious adverse events. Cytokines are believed to have major role in inflammatory process of the airways of the lung. Interleukins play essential roles in the activation and differentiation of immune cells, as well as proliferation, maturation, migration, and adhesion. Interleukins also have pro-inflammatory and anti-inflammatory properties. Interleukins play important roles in the regulation of cytokines and signal transduction during the Ig-E synthesis and play a pivotal role in the pathobiology of asthma. The primary function of interleukins is, therefore, to modulate growth, differentiation, and activation during inflammatory and immune responses. The Interleukin-13 causes increased mucus production by epithelial cells, increased collagen synthesis by fibroblasts and inhibits pro-inflammatory cytokine production. Interleukin-13 works together with Interleukin-4 in producing biologic effects associated with allergic inflammation and in defence against parasites. Interleukins -13 is mostly responsible for airway hyper-responsiveness, mucus overproduction, and bronchial structural changes, Nitric oxide production, goblet cell metaplasia and fibroblast proliferation, as well as elicits contractile responses and hyperplasia of smooth muscle cells in the airways .The main Dosha involvement here is Kapha & Vata and the Gati of Vata is Pratiloma.The Pratiloma gati of Vayu must be brought to Anulomana. So, this pathogenesis is broken by Kapha Vataghna and Ushna guna Aushadha. And to achieve this, Virechana Karma is the process that does the Vata Anulomana and is Kapha-Vataghna. Secondly, Dusti of Pitta Sthana is the root cause of this disease and for removal of this Dushta Pitta Virechana Karma is said to the best procedure. Virechana Karma is indicated in Tamaka Shwasa.These cytokines exert key functions about inception, persistence and amplification of bronchial inflammation and remodeling. To test the hypothesis that serum IL-13 levels may be elevated in this cohort of patients, a property that could make them possible candidate biomarkers in determining asthma occurrence and severity. Serum Levels of IL-13, will be determined by an enzyme-linked immune-sorbent assay (ELISA). So, till now the studies to assess the effect of Virechana on inflammatory markers or on Interleukins has not been carried out in Tamaka shwasa (Bronchial asthma). Virechana karma as a prospective study. The study will be intendent to Evaluate the effect of Virechana karma on Interleukins (Inflammatory marker’s) in Tamaka shwasa (Bronchial Asthma)- Single arm Clinical study.