Gupta Arun, Vedula Sasibhushan, Srivastava Ruchi, Tamoli Sanjay, Mundhe Narendra, Wagh D N, Batra Sanjay, Patil Manoj, Pawar Hiren Baburao, Rai Rajiva K
Healthcare Research, Dabur Research and Development Centre, Dabur India Limited, Uttar Pradesh, India.
Target Institute of Medical Research, Mumbai, India.
J Pharm Bioallied Sci. 2021 Apr-Jun;13(2):256-267. doi: 10.4103/jpbs.jpbs_242_21. Epub 2021 May 26.
The traditional healthcare systems are being avidly looked into in the quest for effective remedies to tackle the menace of COVID-19 pandemic.
This was a prospective randomized, controlled open-label, blinded end point (PROBE) study to evaluate the efficacy and safety of a fixed ayurvedic regimen (FAR) as an add-on to conventional treatment/standard of care (SOC) in the management of mild-to-moderate COVID-19 infection.
A total of 68 patients were recruited who consumed either FAR + SOC ( = 35) or SOC only ( = 33) for 28 days. Primary outcomes assessed were mean time required for clinical recovery and proportion of patients showing clinical recovery between the groups. Secondary outcomes assessed included mean time required for testing SARS-CoV-2 negative, change in clinical status on World Health Organization (WHO) ordinal scale, number of days of hospitalization, change in disease progression and requirement of oxygen/intensive care unit admission/ventilator support/rescue medication, health status on WHO quality of life (QOL) BREF and safety on the basis of occurrence of adverse event/serious adverse event (AE/SAE) and changes in laboratory parameters.
Patients consuming FAR as an add-on SOC showed faster clinical recovery from the day of onset of symptoms by 51.34% ( < 0.05) as compared to SOC group. A higher proportion of patients taking FAR recovered within the first 2 weeks compared to those taking only SOC. It was observed that 5 times more patients recovered within 7 days in FAR group when compared to SOC ( < 0.05) group. An earlier clinical recovery was observed in clinical symptoms such as sore throat, cough, loss of taste and myalgia ( < 0.05). Improvement in postclinical symptoms such as appetite, digestion, stress and anxiety was also obs served to be better with the use of FAR. Requirement of rescue medications such as antipyretics, analgesics and antibiotics was also found to be reduced in the FAR group ( < 0.05). FAR showed a significant improvement in all the assessed domains of QOL. None of the AEs/SAE reported in the study were assessed to be related to the study drugs. Further, FAR did not produce any significant change in the laboratory safety parameters and was assessed to be safe.
FAR could be an effective and safe add-on ayurvedic regimen to standard of care in the management of mild and moderate COVID-19 patients. CTRI number: CTRI/2020/09/027914.
在寻求有效疗法以应对新冠疫情的威胁时，传统医疗体系正受到热切关注。
这是一项前瞻性随机、对照开放标签、盲终点（PROBE）研究，旨在评估固定阿育吠陀疗法（FAR）作为常规治疗/标准治疗（SOC）的附加疗法用于治疗轻至中度新冠感染的疗效和安全性。
共招募了68例患者，他们接受FAR + SOC（n = 35）或仅接受SOC（n = 33）治疗28天。评估的主要结局为临床康复所需的平均时间以及两组间实现临床康复的患者比例。评估的次要结局包括检测SARS-CoV-2呈阴性所需的平均时间、世界卫生组织（WHO）序贯量表上临床状态的变化、住院天数、疾病进展变化以及氧气/重症监护病房入院/呼吸机支持/抢救药物的需求、WHO生活质量（QOL）简表中的健康状况，以及基于不良事件/严重不良事件（AE/SAE）的发生情况和实验室参数变化的安全性。
与SOC组相比，接受FAR作为SOC附加疗法的患者从症状出现之日起临床康复速度快51.34%（P < 0.05）。与仅接受SOC的患者相比，服用FAR的患者在前2周内康复的比例更高。观察到FAR组在7天内康复的患者数量是SOC组的5倍（P < 0.05）。在咽痛、咳嗽、味觉丧失和肌痛等临床症状方面观察到更早的临床康复（P < 0.05）。使用FAR后，食欲、消化、压力和焦虑等临床后症状的改善也更好。FAR组中退烧药、镇痛药和抗生素等抢救药物的需求也有所减少（P < 0.05）。FAR在所有评估的生活质量领域均显示出显著改善。研究中报告的不良事件/严重不良事件均未被评估为与研究药物有关。此外，FAR在实验室安全参数方面未产生任何显著变化，且被评估为安全。
FAR可能是一种有效且安全的阿育吠陀附加疗法，用于轻中度新冠患者的标准治疗。临床试验注册号：CTRI/2020/09/027914。
