Evaluation of AYUSH PE Eye drops in the management of acute allergic conjunctivitis An open-labeled single-arm prospective multicenter clinical trial

• Published in: Ayu Vol. 43; no. 4; pp. 130 - 135
• Main Authors: Balakrishnan, Praveen, Srivastava, Alok, Bhavya, B. M., Jadhav, Nandini, Goel, Sumeet, Khanduri, Shruti, Namdev, Kamble Pallavi, Dua, Mridula, Ratheesh, P., Sumedhan, Varsha, Sinimol, T. P., Naik, Raghavendra, Singhal, Richa, Rana, Rakesh, Singh, Arjun, Rao, B. C. S., Srikanth, Narayanam, Dhiman, Kartar Singh
• Format: Journal Article
• Language: English
• Published: 01.10.2022
• ISSN: 0974-8520
• DOI: 10.4103/ayu.ayu_83_22

Abstract Introduction: Ocular allergy is one of the most common prevalent clinical conditions in the world with a rapid increase in the past few years. It has a multifactorial etiology and is a conjunctival inflammatory response due to immunoglobulin E-mediated mast cell activation. The disease is characterized by itching, redness, burning sensation, and watering of eyes which go off and on. Abhishyanda , a disease having similar characteristics, is described in Ayurveda, for which extensive treatment modalities are available in the classical texts. Hence, a safe, and cost-effective potent Ayurveda drug, AYUSH PE Eye drops was developed after undergoing all quality assurance tests. Materials and methods: A multicenter open-labeled single-group prospective study was conducted at four research institutes of the Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, from May 2019 to December 2019. A total of 221 participants who had signs and symptoms of acute manifestation of allergic conjunctivitis (AC) were enrolled based on purposive sampling at four study sites. The participants were evaluated based on the signs and symptoms of AC using the visual analog scale score (0–100). Two drops of the drug AYUSH PE Eye drops were instilled to the affected eyes six times a day and the patients were reviewed after 1 week. The medicine was then stopped and a second follow-up was done again after 1 more week. Results: A total of 217 participants were analyzed for the outcomes. Statistically significant changes were observed in all the assessment parameters, namely itching, redness of eyes, watery discharge, lid swelling, foreign body sensation, liking for warm touches, heaviness in eyes, feeling of stickiness in eyes, the appearance of allergic hue in eyes, feeling of excessive cold in eyes, and slimy secretions from eyes at 7 th day ( P < 0.001) and at 14 th day ( P < 0.001) as compared to baseline. Conclusion: AYUSH PE Eye drops are safe and effective in the management of acute AC.