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一项开放标签、前瞻性、多中心临床研究,旨在评估阿尤阿蒂斯胶囊对膝骨关节炎患者的疗效。

An open-label, prospective, multicenter, clinical study to evaluate efficacy of Ayuartis capsules in patients suffering from osteoarthritis of the knee(s).

作者信息

Mundhe Narendra B, Tamoli Sanjay Motilal, Pande Shishir Purushottam, Kulkarni Savita Ambadas, Patil Vishal G, Mahadik Swapnali B

机构信息

Department of Kayachikitsa, KVTR Ayurvedic College, Dhule, Maharashtra, India.

Department of Medical Research, Target Institute of Medical Education and Research, Malad West, Mumbai, India.

出版信息

Ayu. 2019 Jan-Mar;40(1):16-22. doi: 10.4103/ayu.AYU_8_18.

Abstract

BACKGROUND

The management of chronic degenerative joint disorders such as osteoarthritis (OA) with ayurvedic medicines provides a safe and effective alternative. Ayurvedic medicines possess analgesic, anti-inflammatory, anti-oxidant and immunomodulator activities.

AIMS

The main aim of the study was to assess the efficacy of Ayuartis capsule in patients suffering from OA of the knee(s).

MATERIALS AND METHODS

Thirty-one patients suffering from OA knee(s) were recruited after evaluating them as per inclusion/exclusion criteria. Patients were advised to take two Ayuartis capsules twice daily orally for 90 days. Knee joint(s) pain was assessed on the Visual Analog Scale. Patients' joint pain, stiffness, and physical functions were assessed on the Western Ontario McMaster University Osteoarthritis (WOMAC) index. Quality of life (QOL) and the time required to walk 50 feet was evaluated. Patients were called for follow-up visits on every 15 day till 90 days. Adverse events and vitals were recorded at every visit. Safety laboratory investigations were done before and after the completion of trial.

STATISTICAL ANALYSIS

Data describing quantitative measures are expressed as mean ± standard deviation. The comparison of variables representing categorical data was performed using pair -test.

RESULTS

The mean joint pain reduced significantly by 53.82% on day 90. The mean WOMAC combined score, pain score, stiffness score and difficulty score reduced significantly by 50.88%, 54.96%, 58.76% and 49.02%, respectively on day 90. A significant improvement was observed in mean QOL of patients. A significant reduction in mean time required to walk 50 feet was observed. Majority of the patients had shown good overall improvement and excellent tolerability to the trial drug.

CONCLUSION

Ayuartis capsule is a safe and effective medicine for the treatment of OA of the knee(s).

摘要

背景

使用阿育吠陀药物治疗骨关节炎(OA)等慢性退行性关节疾病提供了一种安全有效的替代方法。阿育吠陀药物具有止痛、抗炎、抗氧化和免疫调节活性。

目的

本研究的主要目的是评估阿育阿蒂斯胶囊对膝关节骨关节炎患者的疗效。

材料与方法

根据纳入/排除标准对31例膝关节骨关节炎患者进行评估后招募。建议患者每天口服两次阿育阿蒂斯胶囊,每次两粒,持续90天。采用视觉模拟量表评估膝关节疼痛。根据西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评估患者的关节疼痛、僵硬程度和身体功能。评估生活质量(QOL)和行走50英尺所需时间。在90天内,每15天对患者进行随访。每次就诊时记录不良事件和生命体征。在试验开始前和结束后进行安全性实验室检查。

统计分析

描述定量测量的数据以平均值±标准差表示。使用配对检验对代表分类数据的变量进行比较。

结果

在第90天时,平均关节疼痛显著降低了53.82%。在第90天时,WOMAC综合评分、疼痛评分、僵硬评分和困难评分的平均值分别显著降低了50.88%、54.96%、58.76%和49.02%。观察到患者的平均生活质量有显著改善。观察到行走50英尺所需的平均时间显著减少。大多数患者对试验药物总体改善良好且耐受性极佳。

结论

阿育阿蒂斯胶囊是治疗膝关节骨关节炎的一种安全有效的药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cb51/6891992/2f0289bbff40/AYU-40-16-g001.jpg

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