辣木（Withania somnifera）和姜黄（Zingiber officinale）治疗轻中度 COVID-19 的疗效：一项开放标签随机对照探索性试验。

Ashwagandha (Withania somnifera) and Shunthi (Zingiber officinale) in mild and moderate COVID-19: An open-label randomized controlled exploratory trial.

机构信息

Department of Ayurveda, Central Ayurveda Research Institute, Patiala, Punjab, India.

Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India.

出版信息

Complement Ther Med. 2023 Sep;76:102966. doi: 10.1016/j.ctim.2023.102966. Epub 2023 Jul 22.

DOI:10.1016/j.ctim.2023.102966

PMID:37482107

Abstract

BACKGROUND

Ayurveda interventions have been used for prophylaxis and care during the COVID-19 pandemic in India and have shown promising results in promoting early clinical recovery from COVID-19.

OBJECTIVE

To assess the efficacy and safety of Ashwagandha [Withania somnifera (L.) Dunal] tablet and Shunthi (Zingiber officinale Roscoe) capsule in mild and moderate COVID-19 compared to conventional standard care.

METHODS

A randomized controlled exploratory trial was conducted at a designated COVID-19 care center in India with 60 participants having mild or moderate COVID-19. Ashwagandha, two tablets (250 mg each), and Shunthi, two capsules (500 mg each) twice daily for 15 days, were given orally to the participants in the Ayurveda group (AG) and the control group (CG) received conventional standard care. The outcome measures included clinical recovery rate, the proportion of participants with negative RT-PCR assay for COVID-19 on day 7 and day 15, mean time to attain clinical recovery, change in pro-inflammatory markers, serum IgG for COVID-19, HRCT chest findings, disease progression and incidence of adverse events (AE).

RESULTS

A total of 60 participants were enrolled, and the data of 48 participants (AG = 25 and CG = 23) were considered for the statistical analysis. The mean time for clinical recovery was reduced by almost 50 % in the AG (6.9 days) compared to CG (13.0 days) (p < 0.001). The proportion of participants who attained viral clearance in AG was 76.0 % compared to 60.8 % in the CG (RR= 1.24, 95 % CI: 0.841, 1.851, p-value = 0.270). Changes in the pro-inflammatory markers, serum IgG for COVID-19, and HRCT chest findings were comparable in both groups, and no AE or disease progression was reported.

CONCLUSIONS

The Ayurveda interventions, Ashwagandha and Shunthi, can effectively reduce the duration of clinical recovery and improve time for viral clearance in mild and moderate COVID-19. These interventions were observed to be safe and well-tolerated during the duration of the trial.

TRIAL REGISTRATION

Clinical Trial Registry of India - CTRI/2020/08/027224.

摘要

背景

在印度，阿育吠陀干预措施已被用于 COVID-19 大流行的预防和护理，并在促进 COVID-19 的早期临床康复方面显示出良好的效果。

目的

评估 Ashwagandha [Withania somnifera (L.) Dunal] 片剂和 Shunthi（姜黄）胶囊在轻度和中度 COVID-19 中的疗效和安全性，与常规标准护理相比。

方法

在印度的一个指定的 COVID-19 护理中心进行了一项随机对照探索性试验，共有 60 名患有轻度或中度 COVID-19 的参与者。阿育吠陀组（AG）给予 Ashwagandha，每天两次，每次两片（每片 250mg），Shunthi，每天两次，每次两粒（每粒 500mg），共 15 天，而对照组（CG）给予常规标准护理。主要观察指标包括临床康复率、第 7 天和第 15 天 COVID-19 逆转录聚合酶链反应（RT-PCR）检测阴性的参与者比例、达到临床康复的平均时间、炎症标志物变化、COVID-19 血清 IgG、胸部高分辨率计算机断层扫描（HRCT）结果、疾病进展和不良反应（AE）发生率。

结果

共有 60 名参与者被纳入研究，其中 48 名参与者（AG = 25 名，CG = 23 名）的数据被纳入统计分析。AG 组的临床康复时间比 CG 组（6.9 天）缩短了近 50%（p<0.001）。AG 组达到病毒清除的参与者比例为 76.0%，而 CG 组为 60.8%（RR=1.24，95%置信区间：0.841，1.851，p 值=0.270）。两组的炎症标志物、COVID-19 血清 IgG 和 HRCT 胸部发现的变化无差异，且无 AE 或疾病进展报告。