An open label randomised controlled trial to assess the effect of Harishadi Ghana Vati & Virechan Karmain the management of Tamaka Shwasavis-a-vis Bronchial asthma

Abstract

Background: Bronchial asthma, characterised by chronic bronchial hyperactivity and varying degrees of obstruction, is one among the leading causes of respiratory deaths across the globe. Tamaka Shwasa, a variant of Shwasa Roga bears resemblance with bronchial asthma in its symptoms. Ayurveda offers an array of Shodhana (Purification) and Shamana (Pacification) procedures for effective management of Tamaka swasa (bronchial asthma), which can be applied in the former disease too. Aim: The present study is aimed to evaluate the efficacy of Harishadi Ghana Vati and Virechana karma in the management of Tamaka Shwasa (Bronchial Asthma). Materials and methods: 63 patients were enrolled randomly in three groups A, B and C, irrespective of their genders, between the age group of 30-60 years, with confirmed diagnosis of Bronchial Asthma. Out of which, 60 patients completed the trial with Harishadi Ghana Vati 500 mg TDS for 2 months, individually in Group A and after Virechana Karma (Purgation) in group B, Doxofylline 400 mg OD in group C. Change in the grading of complaints and mean values pulmonary function test (PFT) from their baseline value were studied as the primary outcome. Results: Group B has highly significant clinical improvement with all safety profile in comparison to group C. Conclusion: significant clinical improvement was found in group B as compared to other groups. KeywordsTamaka Shwasa, Bronchial asthma, Virechana, Shamana chikitsa. An open label randomised controlled trial to assess the effect of Harishadi Ghana Vati & Virechan Karma in the management of Tamaka Shwasa vis-a-vis Bronchial asthma Dr. Nitin Dr. Abhinav Prof. Rajendra Prasad P a g e | 2 Research Article. IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION This work is licensed under a creative attribution -Non-commercial-No derivatives 4.0 International License commons How to cite this article: -. Dr. Nitin, Dr. Abhinav, Prof. Rajendra Prasad, An open label randomized controlled trial to assess the effect of Harishadi Ghana Vati & Virechan Karma in the management of Tamaka Shwasa vis-a-vis Bronchial asthma, IRJAY, February: 2021, Vol-4, Issue-2; 1-11; DOI: https://doi.org/10.47223/IRJAY.2021.4208 INTRODUCTION Bronchial asthma is a heterogeneous disease, usually characterized by chronic airway inflammation, together with variable expiratory airflow limitation . Epidemiological data suggests a multifactorial causation like environmental pollution, mental stress, irregular & un-wholesome dietary habits & exposure to a wide range of allergens . An estimated report states that more than 339 million people had affected by asthma worldwide in 2016 . According to the WHO report, approximately 417,918 people die every year globally, and 24.8 million DALYS with asthma in 2016. By 2025, an additional 100 million more cases of asthma are expected globally . Tamaka Shwasa (Purgation) is a disorder of Kapha-Vata predominance, originating from Pittasthana (Chakrapani Charaka Samhita, Nidana Sthana;17/8) and presents with acute respiratory symptoms of frequent episodes of severe Kasa (Dry cough), Shwasa (Dyspnea), Rudho (Congested or obstructed airway), Ghurghurkam (Peculiar sound like wheezing) and Peenasa (Rhinitis), in presence of various degree of aggravating factors (Chakrapani Charaka Samhita, Chikitsa Sthana;17/56-57) [5], . This is said to be Sadhya (curable/reversible) in early-stage and Yapya (controlled only with medication/ irreversible) in the later stage (Chakrapani Charaka Samhita, Chikitsa Sthana;17/62) [5], . In spite of effective anti-asthmatic drugs in the modern system of medicine, being a chronic illness, long-term safety profile poses a question . Ayurvedic medicines possess an upper hand here, though not devoid of lacunae. Ayurvedic formulations, though effective are not often readily available and economically feasible, hence out of the reach of vast majority of the population. This study is aimed at developing a formulation that is cheap, easily available, and effective in the management of Bronchial asthma. AIMS & OBJECTIVES i. To assess the efficacy of ‘Harishadi Ghana Vati” in the management of Tamaka Shwasa (bronchial asthma). ii. To assess the efficacy of Virechana Karma (Purgation) followed by Harishadi Ghana Vati in the management of Tamaka Shwasa (bronchial asthma). iii. To compare the efficacy of Shodhana Purvaka Shamana Chikitsa and Shamana Chikitsa (Pacification treatment) in the management of Tamaka Shwasa (bronchial asthma). MATERIALS AND METHODS 63 patients with confirmed diagnosis of Bronchial asthma were enrolled from the OPD/IPD of Kayachikitsa department, IMS, BHU, Varanasi. The clinical trial was registered in the CTRI No. REF/2019/03/024538, and approved by the IEC No. Dean/2018/EC/505. Randomized control open trial Sampling was applied and the patients were divided into three groups. Out of which, 3 participants didn’t continue the trial in group B. ❖ Group A (n=20): Harishadi Ghana Vati 500 mg thrice a day. ❖ Group B (n=23): “Virechana Karma followed by Harishadi Ghana Vati 500 mg thrice a day. ❖ Group C (n=20): Tablet Doxofylline 400mg once a day. P a g e | 3 Research Article. IRJAY IS OFFICIAL JOURNAL OF BALA G PUBLICATION Inclusion criteriaConfirmed case of Tamaka Shwasa (Bronchial Asthma), with duration of illness less than five years, of either sex, aged between 31-60 years, with classical features like Ghurghurak (Wheeze), Shwasa (Dyspnoea), Kasa (Cough) and Parshwa peeda (Chest tightness) and laboratory investigations (PEFR > 80 to <300 Lit/min) were included in the study. Exclusion criteriaPatients suffering from major systemic illnesses like hypertension, tuberculosis, other variants of asthma, age group <30 & >60 years, chronicity >5 years, pregnant and lactating women were excluded from this study. Clinical criteria for assessmentA standard proforma was designed incorporating Ayurvedic and modern methods of examination. All the symptoms were graded according to severity and assessed periodically before (BT) and after treatment (AT) as depicted in table no. 1. Table 1: showing symptoms grading scale Sign and symptoms Grade Score Dyspnoea (Breathlessness)/ Modified Medical Research Council (mMRC) breathlessness on exertion scale Only get breathless with strenuous exercise Get shortness of breath when hurrying on the level or uphill Walks slower than person of same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level Stops after walking 100 yards or after few minutes on the level Too breathlessness to leave the house or when dressing 0 1 2