Publication:

A double blind, randomized, placebo controlled, phase IV, proof-of-concept, comparative study to evaluate the efficacy and safety of Swasawin asthaloc tablets when given as add-on therapy in patients suffering from mild to moderate persistent bronchial asthma

Background Asthma, known as “Tamaka Shwasa” in Ayurveda, as a chronic inflammatory disorder of the airways associated with increased airway hyper-responsiveness, recurrent episodes of wheezing, breathlessness, chest tightness and coughing, particularly at night/early morning. The key component to improving control and preventing attacks is the avoidance of triggers. Swasawin Asthaloc tablet, a polyherbal proprietary medication, is claimed to be effective in asthma. The Objective of the study was to evaluate the safety and efficacy of Swasawin Asthaloc tablets when given as add-on therapy to patients suffering from mild to moderate persistent bronchial asthma.

Methods The study was initiated after receiving Institutional Ethics Committee approval. Patients suffering from mild-to-moderate persistent bronchial asthma were randomized to 2 study groups after written informed consent process for 6 months. Group I received the study medication Swasawin Asthaloc tablet (1 tablet twice daily) in addition to regular anti-asthmatic medications (inhaler ± oral medications). Group II received Placebo tablets in a similar dose as add-on therapy. The study efficacy parameters included spirometry, breath holding time (BHT), Asthma symptom score and Ayurvedic Asthma symptom score.

Results 60 patients were enrolled in the study, of which 50 patients completed the study. In case of spirometry, both FEV1 and PEFR values showed statistically significant improvement at the end of 6 months therapy. Significant improvement in the Breath Holding Time (BHT), Ayurvedic Asthma symptom score and Asthma symptom score was observed in the active group as compared to the baseline (p <0.001).

Conclusions Add-on therapy with Swasawin Asthaloc tablets helped in reducing bronchial inflammation and improving asthmatic symptoms by virtue of its anti-inflammatory, bronchodilatory and antihistaminic properties. Hence it can be used as add-on therapy in patients with mild-to-moderate persistent bronchial asthma and may decrease the need for rescue medications especially steroids.