Department of Ayurveda, Central Ayurveda Research Institute, Patiala, Punjab, India.
Department of Ayurveda, Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh, India.
Complement Ther Med. 2022 Jun;66:102814. doi: 10.1016/j.ctim.2022.102814. Epub 2022 Feb 8.
To determine the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in mild to moderate COVID-19.
DESIGN SETTING, AND INTERVENTIONS: This open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India in 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone.
Proportion of participants who attained clinical recovery on day 7, 15, 23 and 30, proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point, change in pro-inflammatory markers, metabolic functions, HRCT chest (CO-RADS category) and incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE).
Out of 80 participants, 74 (37 in each group) contributed to the final analysis. Significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. Mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG.
AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.
确定 AYUSH-64 作为标准治疗的附加治疗在轻度至中度 COVID-19 中的疗效和安全性。
设计、设置和干预：这项开放标签随机对照平行组试验在印度的一个指定 COVID 护理中心进行，共纳入 80 名轻度至中度 COVID-19 患者，并随机分为两组。AYUSH-64 附加组（AG）的参与者每天服用 AYUSH-64 两片（每片 500 毫克），每天 3 次，共 30 天，同时接受标准常规护理。对照组（CG）仅接受标准护理。
第 7、15、23 和 30 天达到临床康复的参与者比例，每周时间点 COVID-19 逆转录聚合酶链反应（RT-PCR）检测结果为阴性的参与者比例，促炎标志物、代谢功能、高分辨率计算机断层扫描（CO-RADS 分类）和不良药物反应（ADR）/不良事件（AE）的变化。
在 80 名参与者中，有 74 名（每组 37 名）完成了最终分析。AG 组在临床康复方面的差异有统计学意义（p<0.001）。AG 组（5.8±2.67 天）的临床康复平均时间明显短于 CG 组（10.0±4.06 天）。AG 组的胸部高分辨率计算机断层扫描（HRCT）有明显改善（p=0.031），而 CG 组则无（p=0.210）。AG 组未观察到或报告 ADR/SAE。
AYUSH-64 作为标准治疗的辅助治疗在加速轻度至中度 COVID-19 的临床康复方面是安全有效的。更大规模的多中心双盲试验可能进一步验证其疗效。
