{"title":"这是一项随机、安慰剂对照、双盲、平行组临床研究，目的是评估 AEV01 与标准疗法一起用于轻度 COVID-19 老年患者的疗效和安全性。","authors":"Aravinda Kumar Balan , Ramesh Kannan , Vanitha Muralikumar , Vamseedhar Annam , Sakthi Balan Murugesan , MM Sekhar , Renu Medasani","doi":"10.1016/j.jaim.2023.100860","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>While several drugs are in the pipeline for treatment of various grades of COVID-19 disease, none of them have shown promise until now. Medicinal plants are crucial in developing and developed countries for their primary and basic health needs owing to better tolerability, superior compatibility with human body and having lesser side effects. <strong>Objective:</strong> To test adjuvant effect of AEV01, a patented herbal extract of kutki (<em>Picrorhiza kurroa</em>), in mild COVID19 in elderly patients at risk of complications and aging immunity.</p></div><div><h3>Methods</h3><p>A prospective, phase 3, randomized, multicentric, placebo controlled double blinded parallel group interventional trial was conducted in elderly patients aged above 50 years diagnosed as COVID-19 with mild symptoms. 70 patients were randomized into two groups to receive AEV01 capsule (100 mg) and placebo respectively thrice daily for 30 days along with standard care of treatment as per national (WHO/ICMR) guidelines in both the groups. Clinical improvement timelines and corresponding scores using 8-point ordinal scale and NEWS were assessed for efficacy and safety of AEV01 in COVID-19 patients.</p></div><div><h3>Results</h3><p>AEV01 group showed a significant improvement (p = 0.0001) in the normalization of the SpO<sub>2</sub> rate and relief from cough. There was also significant difference in time to recovery, with patients in the AEV01 drug treated group recovering in 4.5 days as compared to Placebo in 9.1 days. ESR, LDH, serum ferritin, Neutrophil-Lymphocyte ratio (NLR), TNF- alpha, IL-6 and CD4 cell counts, which are considered as prognostic markers in COVID-19 infected patients, showed a significant improvement in patients treated with AEV01. The AEV01 drug treated group showed significant clinical improvement in the 8-point ordinal scale severity rating and National Early Warning Score (NEW) Score from day 3 onwards which continued up to end of study.</p></div><div><h3>Conclusion</h3><p>AEV01 has shown a significant improvement in clinical and laboratory parameters. There was also reduction in the progression of the COVID-19 disease in unvaccinated elderly patients from mild to moderate when treated at an earlier stage.</p></div>","PeriodicalId":15150,"journal":{"name":"Journal of Ayurveda and Integrative Medicine","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0975947623001778/pdfft?md5=0110d4d7e17c8defdae0541fbd0bb29d&pid=1-s2.0-S0975947623001778-main.pdf","citationCount":"0","resultStr":"{\"title\":\"A randomized, placebo controlled, double blinded, parallel group clinical study to evaluate the efficacy and safety of AEV01 along with standard care for elderly patients with mild COVID-19\",\"authors\":\"Aravinda Kumar Balan , Ramesh Kannan , Vanitha Muralikumar , Vamseedhar Annam , Sakthi Balan Murugesan , MM Sekhar , Renu Medasani\",\"doi\":\"10.1016/j.jaim.2023.100860\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>While several drugs are in the pipeline for treatment of various grades of COVID-19 disease, none of them have shown promise until now. Medicinal plants are crucial in developing and developed countries for their primary and basic health needs owing to better tolerability, superior compatibility with human body and having lesser side effects. <strong>Objective:</strong> To test adjuvant effect of AEV01, a patented herbal extract of kutki (<em>Picrorhiza kurroa</em>), in mild COVID19 in elderly patients at risk of complications and aging immunity.</p></div><div><h3>Methods</h3><p>A prospective, phase 3, randomized, multicentric, placebo controlled double blinded parallel group interventional trial was conducted in elderly patients aged above 50 years diagnosed as COVID-19 with mild symptoms. 70 patients were randomized into two groups to receive AEV01 capsule (100 mg) and placebo respectively thrice daily for 30 days along with standard care of treatment as per national (WHO/ICMR) guidelines in both the groups. Clinical improvement timelines and corresponding scores using 8-point ordinal scale and NEWS were assessed for efficacy and safety of AEV01 in COVID-19 patients.</p></div><div><h3>Results</h3><p>AEV01 group showed a significant improvement (p = 0.0001) in the normalization of the SpO<sub>2</sub> rate and relief from cough. There was also significant difference in time to recovery, with patients in the AEV01 drug treated group recovering in 4.5 days as compared to Placebo in 9.1 days. ESR, LDH, serum ferritin, Neutrophil-Lymphocyte ratio (NLR), TNF- alpha, IL-6 and CD4 cell counts, which are considered as prognostic markers in COVID-19 infected patients, showed a significant improvement in patients treated with AEV01. The AEV01 drug treated group showed significant clinical improvement in the 8-point ordinal scale severity rating and National Early Warning Score (NEW) Score from day 3 onwards which continued up to end of study.</p></div><div><h3>Conclusion</h3><p>AEV01 has shown a significant improvement in clinical and laboratory parameters. There was also reduction in the progression of the COVID-19 disease in unvaccinated elderly patients from mild to moderate when treated at an earlier stage.</p></div>\",\"PeriodicalId\":15150,\"journal\":{\"name\":\"Journal of Ayurveda and Integrative Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0975947623001778/pdfft?md5=0110d4d7e17c8defdae0541fbd0bb29d&pid=1-s2.0-S0975947623001778-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Ayurveda and Integrative Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0975947623001778\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Ayurveda and Integrative Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0975947623001778","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
A randomized, placebo controlled, double blinded, parallel group clinical study to evaluate the efficacy and safety of AEV01 along with standard care for elderly patients with mild COVID-19
Background
While several drugs are in the pipeline for treatment of various grades of COVID-19 disease, none of them have shown promise until now. Medicinal plants are crucial in developing and developed countries for their primary and basic health needs owing to better tolerability, superior compatibility with human body and having lesser side effects. Objective: To test adjuvant effect of AEV01, a patented herbal extract of kutki (Picrorhiza kurroa), in mild COVID19 in elderly patients at risk of complications and aging immunity.
Methods
A prospective, phase 3, randomized, multicentric, placebo controlled double blinded parallel group interventional trial was conducted in elderly patients aged above 50 years diagnosed as COVID-19 with mild symptoms. 70 patients were randomized into two groups to receive AEV01 capsule (100 mg) and placebo respectively thrice daily for 30 days along with standard care of treatment as per national (WHO/ICMR) guidelines in both the groups. Clinical improvement timelines and corresponding scores using 8-point ordinal scale and NEWS were assessed for efficacy and safety of AEV01 in COVID-19 patients.
Results
AEV01 group showed a significant improvement (p = 0.0001) in the normalization of the SpO2 rate and relief from cough. There was also significant difference in time to recovery, with patients in the AEV01 drug treated group recovering in 4.5 days as compared to Placebo in 9.1 days. ESR, LDH, serum ferritin, Neutrophil-Lymphocyte ratio (NLR), TNF- alpha, IL-6 and CD4 cell counts, which are considered as prognostic markers in COVID-19 infected patients, showed a significant improvement in patients treated with AEV01. The AEV01 drug treated group showed significant clinical improvement in the 8-point ordinal scale severity rating and National Early Warning Score (NEW) Score from day 3 onwards which continued up to end of study.
Conclusion
AEV01 has shown a significant improvement in clinical and laboratory parameters. There was also reduction in the progression of the COVID-19 disease in unvaccinated elderly patients from mild to moderate when treated at an earlier stage.
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