Andrographis paniculata extract versus placebo in the treatment of COVID-19: a double-blinded randomized control trial

IF 2.1 Q3 CHEMISTRY, MEDICINAL
Puritat Kanokkangsadal, Chatchai Mingmalairak, Nichamon Mukkasombat, P. Kuropakornpong, Patsorn Worawattananutai, T. Khawcharoenporn, I. Sakpakdeejaroen, Neal Davies, A. Itharat
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Abstract

Background and purpose: Andrographis paniculata (Burm.f.) Nees has been recommended to relieve symptoms and decrease the severity of COVID-19. The clinical study aimed to investigate the efficacy and safety of A. paniculata ethanolic extract (APE). Experimental approach: The efficacy and safety of APE in asymptomatic or mildly symptomatic COVID-19 patients compared with placebo were investigated through a prospective, double-blind randomized control trial. Patients received APE containing 60 mg of andrographolide, three times a day for five days. WHO progression scale, COVID-19 symptoms, and global assessment evaluated the efficacy and adverse events, liver and renal functions were monitored for safety. Findings/Results: 165 patients completed the study (83 patients in the APE group and 82 patients in the placebo group). The highest WHO progression scale was 4 and COVID-19 symptoms were significantly relieved on the last day of intervention in both groups, with no significant difference between groups. APE significantly relieved headache symptoms on day 1 and olfactory loss symptoms on day 2 compared to placebo. The global assessment showed that 80.7% of patients had total recovery after 5-day treatment with APE. Mild diarrhea was the most common side effect with a high dose that resolved within a few days. No hepatic or renal toxicity was associated with treatment. Conclusion and implications: APE at 180 mg/day for 5 days did not reduce COVID-19 progression in asymptomatic or mildly afflicted COVID-19 patients, however, it shortened the symptoms of olfactory loss with no adverse effects over 5 days of use.
穿心莲提取物与安慰剂治疗 COVID-19:双盲随机对照试验
背景和目的:穿心莲(Burm.f.)Nees被推荐用于缓解COVID-19的症状并减轻其严重程度。本临床研究旨在探讨穿心莲乙醇提取物(APE)的有效性和安全性。实验方法:通过一项前瞻性双盲随机对照试验,研究了APE与安慰剂相比对无症状或轻度症状COVID-19患者的疗效和安全性。患者服用含 60 毫克穿心莲内酯的 APE,每天三次,连续服用五天。通过WHO病情进展量表、COVID-19症状和总体评估来评价疗效,并监测不良反应、肝功能和肾功能以确保安全性。研究结果/成果165 名患者完成了研究(APE 组 83 人,安慰剂组 82 人)。两组患者在干预的最后一天,世界卫生组织(WHO)的最高进展分级为 4 级,COVID-19 症状明显缓解,组间无显著差异。与安慰剂相比,APE 能明显缓解第 1 天的头痛症状和第 2 天的嗅觉减退症状。总体评估显示,80.7%的患者在接受 APE 5 天治疗后完全康复。轻度腹泻是大剂量治疗最常见的副作用,但在数天内即可缓解。治疗过程中未出现肝脏或肾脏毒性反应。结论和影响:APE 180 毫克/天、持续 5 天的剂量并不能降低无症状或轻度 COVID-19 患者的 COVID-19 病程进展,但它能缩短嗅觉减退症状的时间,且在 5 天的用药过程中无不良反应。
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来源期刊
Research in Pharmaceutical Sciences
Research in Pharmaceutical Sciences CHEMISTRY, MEDICINAL-
CiteScore
3.60
自引率
19.00%
发文量
50
审稿时长
34 weeks
期刊介绍: Research in Pharmaceutical Sciences (RPS) is included in Thomson Reuters ESCI Web of Science (searchable at WoS master journal list), indexed with PubMed and PubMed Central and abstracted in the Elsevier Bibliographic Databases. Databases include Scopus, EMBASE, EMCare, EMBiology and Elsevier BIOBASE. It is also indexed in several specialized databases including Scientific Information Database (SID), Google Scholar, Iran Medex, Magiran, Index Copernicus (IC) and Islamic World Science Citation Center (ISC).
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