一项随机对照研究，旨在评估一种包含精油的草药配方对2019冠状病毒病（COVID-19）患者补充治疗的安全性和有效性。
A randomized and comparative study to assess safety and efficacy of supplemental treatment of a herbal formulation - comprising essential oils in patients with corona virus 2019 (COVID-19).
作者信息
Dutt Jayesh, Ganatra Bhavdeep, Suthar Nilay, Malek Mohammedebrahim, Shukla Bhakti, Shukla Krupali, Shukla Karna, Pandit Shreya, Rachchh Manish, Gokani Rina, Bhalani Mona
机构信息
Smt. NHL Municipal Medical College & SVPIMSR, Ellisbridge, Ahmedabad, 380006, Gujarat, India.
Ganatra Ayurveda & Panchkarma Clinic, 125, Advait Complex, Opp Soham Tower, B /s Sandesh Press, Vastrapur, Ahmedabad, 380054, Gujarat, India.
出版信息
Contemp Clin Trials Commun. 2021 Jun;22:100755. doi: 10.1016/j.conctc.2021.100755. Epub 2021 Mar 11.
OBJECTIVE
The purpose of this study was to examine the effect of herbal formulation - Aayudh Advance on viral load as well as recovery duration in mild symptomatic patients diagnosed with Corona Virus Disease 2019 (COVID-19). It also aimed to study the effect of Herbal formulation - Aayudh Advance in terms of clinical improvement of various sign and symptoms in mild symptomatic COVID-19 patients.
METHOD
Once the patient suffice the requirement of inclusion, exclusion criteria of the study than as per the method of 'Covariate Adaptive Randomization' technique, patient was assigned in either Aayudh Advance arm (Test arm) or Control Arm. Here standard of Care treatment was given to all patients of both the arms. Treatment was given for the period of 14 days or till patient turned COVID-19 negative, which ever was earlier. Clinical signs and symptoms viz. body temperature, SpO 2, Scoring of Cough & Scoring of Shortness of breath were recorded on all 5 Clinical visits along with biochemical testing like RT-PCR (with CT value of E gene and RDRP gene), serum ferritin, CRP and NLR observed on weekly Visit.
RESULT
Total 74 patients were enrolled in the present study. Out of which 60 patients (30 patients in each group) have completed study as per the protocol, whereas 14 patients have voluntarily withdrawn from the study due to getting early discharge from the hospital. All patients in Aayudh Advance treatment group recovered (100%) after 14 days. This observed recovery was 15.38% more as compared to Standard of Care treatment alone. Further, there was statistically significant reduction (p < 0.05) in viral load as indicated by significant increase in CT value of E-gene and RDRP gene. Further, no patients reported any Adverse Reaction as well as no drug to drug interaction was observed with supplemental treatment with Aayudh Advance.
CONCLUSION
The Aayudh Advance was found safe as well as more effective in terms of reduction of viral load. % recovery was more in Treatment arm as compared to Control arm in mild symptomatic COVID-19 patients.
目的
本研究旨在探讨草药配方——阿育吠陀进阶疗法对确诊为2019冠状病毒病（COVID-19）的轻症患者病毒载量及康复时间的影响。同时，本研究还旨在研究草药配方——阿育吠陀进阶疗法对轻症COVID-19患者各种体征和症状临床改善情况的影响。
方法
一旦患者满足研究的纳入和排除标准，按照“协变量自适应随机化”技术的方法，将患者分配到阿育吠陀进阶疗法组（试验组）或对照组。两组所有患者均接受标准治疗。治疗为期14天，或直至患者COVID-19检测呈阴性，以先到者为准。在所有5次临床访视时记录临床体征和症状，即体温、血氧饱和度、咳嗽评分和呼吸急促评分，同时在每周访视时进行生化检测，如RT-PCR（E基因和RDRP基因的CT值）、血清铁蛋白、CRP和NLR。
结果
本研究共纳入74例患者。其中60例患者（每组30例）按方案完成研究，14例患者因提前出院而自愿退出研究。阿育吠陀进阶疗法治疗组所有患者在14天后均康复（100%）。与单纯标准治疗相比，观察到的康复率高出15.38%。此外，E基因和RDRP基因的CT值显著增加，表明病毒载量有统计学意义的降低（p < 0.05）。此外，没有患者报告任何不良反应，并且在阿育吠陀进阶疗法辅助治疗中未观察到药物相互作用。
结论
发现阿育吠陀进阶疗法在降低病毒载量方面安全且更有效。在轻症COVID-19患者中，治疗组的康复率高于对照组。
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