Thakar Anup, Goyal Mandip, Bhinde Sagar, Chhotala Yagnik, Panara Kalpesh, Chaudhari Swapnil
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India.
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India.
J Ayurveda Integr Med. 2022 Jul-Sep;13(3):100587. doi: 10.1016/j.jaim.2022.100587. Epub 2022 May 18.
Ayurveda herbal formulation AYUSH-64, proven to treat malaria and influenza-like illness in india was repurposed for COVID-19 patients considering preliminary evidances, however, scientific data was not available.
To evaluate the preliminary efficacy and safety of AYUSH 64 as an add-on to standard of care in mild COVID19 patients.
A single centre, randomized, open-labeled, controlled, pilot study were conducted on mild COVID 19 confirmed patients. Patients allotted in interventional group (n = 41) recieved AYUSH 64, 3 gm per day in three divided dose for 14 days as an adjuvant to standard of care (SOC) whereas control group received SOC (n = 39) alone. Outcomes were reduction in WHO ordinal scale for clinical improvement, all-cause mortality, incidence of COVID19 symptoms among asymptomatic patients at baseline, use for oxygen therapy, use for a mechanical ventilator, the total duration of symptomatic phase and adverse events.
Mean score of WHO ordinal scale was reduced as time lapse in both the groups (f (1) = 20.5, < 0.001) indicating clinical improvement among groups. There was no statistically significant difference in mean WHO ordinal scale between groups (f (1) = 0.98, = 0.32). The proportion of asymptomatic patients progressing to the symptomatic stage is lower in AYUSH 64 group [OR, 0.68 (CI, 0.17-2.66)]. Mean days for the total duration of the symptomatic phase was also short in AYUSH 64 group (4.68 ± 3.29 days) compared to SOC group (5.81 ± 3.5 days). No incidence of the requirement of a mechanical ventilator, adverse drug reaction and death were observed in either of the groups.
The findings of this pilot study show that an integrated approach of AYUSH 64 with SOC provide early trends of benefit by reduction in disease progression and in total symptom duration. However, its effects remains inconclusive on outcomes such as all cause mortality, use of oxygen therapy, invasive ventilator due to sparse outcomes.
印度的阿育吠陀草药配方AYUSH - 64已被证明可治疗疟疾和流感样疾病，鉴于初步证据，该配方被重新用于COVID - 19患者，但尚无科学数据。
评估AYUSH 64作为轻度COVID - 19患者标准治疗附加药物的初步疗效和安全性。
对确诊的轻度COVID - 19患者进行了一项单中心、随机、开放标签、对照的试点研究。干预组（n = 41）的患者接受AYUSH 64，每天3克，分三次服用，共14天，作为标准治疗（SOC）的辅助药物，而对照组（n = 39）仅接受标准治疗。观察指标包括世界卫生组织（WHO）临床改善序数量表评分降低情况、全因死亡率、基线时无症状患者中COVID - 19症状的发生率、吸氧治疗的使用情况、机械通气的使用情况以及症状期的总时长和不良事件。
两组患者的WHO序数量表平均评分均随时间推移而降低（f(1) = 20.5，P < 0.001），表明两组患者均有临床改善。两组之间的WHO序数量表平均评分无统计学显著差异（f(1) = 0.98，P = 0.32）。AYUSH 64组中进展到症状期的无症状患者比例较低[比值比（OR），0.68（置信区间，0.17 - 2.66）]。与标准治疗组（5.81 ± 3.5天）相比，AYUSH 64组症状期的总平均天数也较短（4.68 ± 3.29天）。两组均未观察到机械通气需求、药物不良反应和死亡的发生。
这项试点研究的结果表明，AYUSH 64与标准治疗相结合的综合方法通过减少疾病进展和症状总时长提供了早期有益趋势。然而，由于结果稀少，其对全因死亡率、吸氧治疗的使用、有创通气等结局的影响仍不确定。
