Clinical Efficacy and Safety of Mahatriphaladya Ghrita in the Management of Allergic Conjunctivitis: A Prospective Open Label Multicenter Study

Abstract

Introduction: Allergic conjunctivitis is a mild, nonspecific inflammation of the conjunctiva due to allergy with symptoms of conjunctival congestion, mild papillary response, and intense itching without any known specific condition for pathology to develop or with undetermined etiology that is mostly and easily attributed to allergy. Aims and objectives:To evaluate the efficacy and safety of Mahatriphaladya Ghrita and Triphala Kwath (Aschyotana) in patients suffering from allergic conjunctivitis. Materials and methods:A prospective, open label multicenter study was carried out at two peripheral centers of the Central Council for Research in Ayurvedic Sciences (CCRAS). Totally, 54 patients satisfying the selection criteria were enrolled from the outpatient department (OPD) of these centers and were administered Mahatriphaladya Ghrita (15 mL) twice daily on an empty stomach in the morning and 3 hours before meals in the evening with lukewarm water for 12 weeks and Triphala Kvatha (10 drops) Aschyotana twice daily for 12 weeks. All the participants were subjected to complete physical and ophthalmic examination along with blood investigations. Follow-up was done finally after 2 weeks without medication. Laboratory parameters, viz., absolute eosinophil count (AEC), liver function tests, kidney function tests, lipid profile, total leukocyte count (TLC) were assessed at baseline and at the end of the treatment period of 12 weeks (i.e., 84th day). Paired sample t-test was used to compare mean change from baseline to the 84th day on the outcome variables assessed by visual analog scale (VAS, 0-100 mm) and on the laboratory examination. A p-value of <0.05 was considered significant. Results:At the end of 12 weeks, compared with baseline, statistically significant improvement was observed in symptoms, viz.foreign body sensation (p < 0.001). The treatment was found to be safe and effective in the subjects of allergic conjunctivitis as all the safety parameters were within the stipulated range. No adverse drug reactions or adverse events were reported during the trial period.Conclusion: Mahatriphaladya Ghrita and Triphala Kwath (Aschyotana) administered in the above-mentioned dose were found effective and safe in patients suffering from allergic conjunctivitis.