Kannan M, Sathiyarajeswaran P, Sasikumar D, Geetha A, Mohanapriya M, Vinod N P, Manickam P, Kanakavalli K, Parthibhan P, Pitchiah Kumar M, Kannan R, Sivaraman G
Siddha Central Research Institute, CCRS, Chennai, India.
Siddha Central Research Institute, CCRS, Chennai, India.
J Ayurveda Integr Med. 2022 Jul-Sep;13(3):100589. doi: 10.1016/j.jaim.2022.100589. Epub 2022 May 23.
The Coronavirus disease 2019 (COVID-19) pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a massive threat to public health worldwide. Siddha system of medicine is one of the traditional medicines of South India. The recommended formulations in Siddha Sasthric Medicines- Fixed Regimen (SSM-FiRe) are tablets (KSK) for asymptomatic COVID-19 positive (RT-PCR) patients, and tablets, syrup, tablet, and for mild symptomatic patients. The core objective of the trial was to document the efficacy of SSM-FiRe in the prevention of asymptomatic and mild COVID-19 disease progression to the next level of severity, reduce the severity of symptoms and revert to RT-PCR Negative.
An exploratory, prospective, open-labeled, single-arm, non-randomized trial was designed as per GCP guidelines to assess the efficacy of SSM-FiRe. Sixty RT-PCR positive participants who were asymptomatic or with mild COVID-19 symptoms were recruited for the study at the Siddha COVID Care Centre, Vyasarpadi, Chennai from June to August 2020. Nasal and oropharyngeal swab tests were performed on the 0, 7th, and 14th days. All participants were treated with SSM - FiRe regimen. All the participants were also assessed based on Siddha , which included Clinical symptoms and vitals. Laboratory investigations such as Haemogram, Liver Function Test, Renal Function Test, HbA1C, Electrolytes, Inflammatory markers, Cardiac profile, Immunoglobulins, and anti-SARS-CoV-2 antibody tests were performed.
83% of COVID-19 patients turned RT-PCR negative on the 7th day and in most of the cases, symptoms were reduced within the first 5 days of admission. The RT-PCR cycle threshold (ct) value increased significantly (<0.001) after treatment and all the participants were RT-PCR negative, except one, who was positive even after 14 days. Anti-SARS-CoV-2 antibodies developed significantly (p-value - 0.006). LFT, RFT, CBC, Total proteins, and electrolytes continued to be in the normal range after treatment, indicating the safety of the intervention.
Asymptomatic and mild COVID-19 disease can be well managed by SSM - FiRe treatment, Further studies could be taken up to strengthen the findings.
由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的2019冠状病毒病（COVID-19）大流行对全球公共卫生构成巨大威胁。悉达医学体系是印度南部的传统医学之一。悉达医学固定疗法（SSM-FiRe）中推荐的制剂是用于无症状COVID-19阳性（RT-PCR）患者的片剂（KSK），以及用于轻症患者的片剂、糖浆、片剂和。该试验的核心目标是记录SSM-FiRe在预防无症状和轻症COVID-19疾病进展到下一级严重程度、减轻症状严重程度并使RT-PCR转为阴性方面的疗效。
根据GCP指南设计了一项探索性、前瞻性、开放标签、单臂、非随机试验，以评估SSM-FiRe的疗效。2020年6月至8月，在金奈维亚萨尔帕迪的悉达COVID护理中心招募了60名无症状或有轻症COVID-19症状的RT-PCR阳性参与者进行研究。在第0天、第7天和第14天进行鼻拭子和口咽拭子检测。所有参与者均接受SSM-FiRe方案治疗。所有参与者还根据悉达医学进行评估，包括临床症状和生命体征。进行了血常规、肝功能检查、肾功能检查、糖化血红蛋白、电解质、炎症标志物、心脏检查、免疫球蛋白和抗SARS-CoV-2抗体检测等实验室检查。
83%的COVID-19患者在第7天RT-PCR转为阴性，在大多数情况下，症状在入院后的前5天内减轻。治疗后RT-PCR循环阈值（ct）值显著升高（<0.001），除1名参与者在14天后仍为阳性外，所有参与者RT-PCR均为阴性。抗SARS-CoV-2抗体显著产生（p值 - 0.006）。治疗后肝功能、肾功能、血常规、总蛋白和电解质持续处于正常范围，表明干预措施的安全性。
无症状和轻症COVID-19疾病可以通过SSM-FiRe治疗得到很好的管理，可进一步开展研究以强化这些发现。
