评估眼药水 Mantra 的疗效和安全性:眼部疾病上市后综合监测研究

Shreya Verma, Amrish Verma, Jaspal Singh, Hasan Ali Ahmed, Chetan Jaykar
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摘要

研究目的本研究旨在系统评估眼部曼陀罗滴眼液的疗效和安全性。眼部曼陀罗滴眼液是一种融合了阿育吠陀医学原理和药用植物提取物的现代配方,可用于治疗各种眼部疾病,包括结膜炎、虹膜炎、干眼症、眼疲劳、眼痒和流泪。研究方法研究采用单中心、开放标签、非随机、上市后监测的方法,涉及 120 名患有各种眼部疾病的受试者。受试者连续 7 天服用由 13 种传统成分组成的眼药水。在筛选和研究结束时对症状的频率和严重程度、生命体征和不良事件进行评估,以评价 Eye Mantra Drops 的安全性和有效性。研究结果研究显示,结膜炎、虹膜炎、眼干、眼痒、流泪和眼疲劳等各种眼部症状的发生频率和严重程度都有明显降低。没有不良反应报告,生命体征保持稳定,这表明 Eye Mantra Drops 是安全的。结论眼咒滴眼液对结膜炎、虹膜炎、干眼症、眼疲劳、眼痒和流泪等各种眼部疾病具有良好的治疗效果和耐受性。
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Evaluating the Efficacy and Safety of Eye Mantra Drops: A Comprehensive Post-Marketing Surveillance Study in Ocular Disorders
Objectives: This study aimed to systematically evaluate the efficacy and safety of Eye Mantra Drops, a modern formulation integrating ayurvedic principles and medicinal plant extracts, in addressing various ocular conditions, including conjunctivitis, iritis, dry eyes, eye strain, itchiness, and watery eyes. Methods: The study adopted a single-center, open-label, non-randomized, post-marketing surveillance approach, involving 120 subjects with diverse ocular conditions. Eye Mantra Drops, comprising thirteen traditionally used ingredients, were administered to the participants for 7 days. Frequency and severity of symptoms, vital signs, and adverse events were assessed at screening and at the end of study to evaluate the safety and efficacy of Eye Mantra Drops. Results: The study revealed a significant reduction in frequency and symptom severity across diverse ocular conditions, including conjunctivitis, iritis, dry eyes, itchiness, watery eyes, and eye strain. No adverse events were reported, and vital signs remained stable, indicating the safety of Eye Mantra Drops. Conclusion: Eye Mantra Drops emerged as a promising and well-tolerated intervention for various ocular conditions including conjunctivitis, iritis, dry eyes, eye strain, itchiness, and watery eyes.
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