AYUSH 64 联合标准治疗用于轻中度 COVID-19 的辅助治疗：一项随机、对照、多中心临床试验。
Co-administration of AYUSH 64 as an adjunct to standard of care in mild and moderate COVID-19: A randomized, controlled, multicentric clinical trial.
机构信息
Centre for Rheumatic Diseases, Pune, India.
Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
出版信息
PLoS One. 2023 Mar 16;18(3):e0282688. doi: 10.1371/journal.pone.0282688. eCollection 2023.
OBJECTIVE
Evaluate the efficacy of AYUSH 64, a standard polyherbal Ayurvedic drug in COVID-19.
METHODS
During the first pandemic wave, 140 consenting and eligible hospitalized adult participants with mild-moderate symptomatic disease (specific standard RT-PCR assay positive) were selected as per a convenience sample, and randomized (1:1 ratio) to an open-label (assessor blind) two-arm multicentric drug trial; standard of care (SOC as per Indian guidelines) versus AYUSH 64 combined with SOC (AYUSH plus). Participants were assessed daily and discharged once clinical recovery (CR, primary efficacy) was achieved which was based on a predetermined set of criteria (resolution of symptoms, normal peripheral oximetry, and negative specific RT-PCR assay). Each participant was followed using an indigenous software program(mobile phone) and completed a 12-week study period. The dose of AYUSH 64 was 2 tablets oral, 500 mg each, bid for 12 weeks (AYUSH plus only). Significant P was <0.05 (two-sided). On randomization, the groups were found well matched.
RESULTS
The mean interval time from randomization to CR was significantly superior in the AYUSH plus group [mean 6.45 days versus 8.26 days, 95% Confidence Interval of the difference -3.02 to -0.59 (P = 0.003, Student's 't test] as per-protocol analysis (134 participants); significant (P = 0.002) on an intention to treat analysis. 70% of the participants in AYUSH plus recovered during the first week (P = 0.046, Chi-square) and showed a significantly better change in physical health, fatigue, and quality of life measures. 48 adverse events, mostly mild and gut related, were reported by each group. There were 20 patient withdrawals (8 in AYUSH plus) but none due to an AE. There were no deaths. Daily assessment (hospitalization) and supervised drug intake ensured robust efficacy data. The open-label design was a concern (study outcome).
CONCLUSIONS
AYUSH 64 in combination with SOC hastened recovery, reduced hospitalization, and improved health in COVID-19. It was considered safe and well-tolerated. Further clinical validation (Phase III) is required.
TRIAL REGISTRATION
CTRI/2020/06/025557.
目的
评估 AYUSH 64（一种标准的复方印度草药）在 COVID-19 中的疗效。
方法
在第一波大流行期间，按照便利抽样法选择了 140 名符合条件的住院成年轻症至中度有症状患者（特定标准 RT-PCR 检测阳性）参与研究，并按照 1:1 的比例随机分为开放标签（评估者设盲）的两臂多中心药物试验；标准治疗（SOC，根据印度指南）与 AYUSH 64 联合 SOC（AYUSH 加）。每天对参与者进行评估，一旦达到临床康复（主要疗效），即根据一套预定标准（症状缓解、外周血氧正常和特定 RT-PCR 检测阴性），即可出院。每位参与者均使用本地软件程序（手机）进行随访，并完成 12 周的研究期。AYUSH 64 的剂量为口服 2 片，每片 500mg，bid，共 12 周（仅 AYUSH 加）。显著 P 值<0.05（双侧）。随机分组时，两组发现匹配良好。
结果
根据方案分析（134 名参与者），在 AYUSH 加组中，从随机分组到 CR 的平均时间间隔明显更短[平均 6.45 天对 8.26 天，95%置信区间差值为-3.02 至-0.59（P=0.003，Student's 't 检验）]；意向治疗分析有显著意义（P=0.002）。在 AYUSH 加组中，70%的参与者在第一周内康复（P=0.046，卡方检验），并且在身体健康、疲劳和生活质量方面的改善更为明显。两组均报告了 48 例不良事件，多为轻度和肠道相关。每组均有 20 名患者退出（AYUSH 加组 8 名），但均非因不良事件。无死亡病例。每日评估（住院）和药物监管确保了疗效数据的稳健性。开放性试验设计是一个关注点（研究结果）。
结论
在 SOC 的基础上加用 AYUSH 64 可加速康复、减少住院时间，并改善 COVID-19 患者的健康状况。其被认为是安全且耐受良好的。需要进一步进行临床验证（III 期）。
试验注册
CTRI/2020/06/025557。
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