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Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India
Trials ( IF 2.5 ) Pub Date : 2021-09-15 , DOI: 10.1186/s13063-021-05583-0
S Natarajan 1 , C Anbarasi 1 , P Sathiyarajeswaran 1 , P Manickam 2 , S Geetha 3 , R Kathiravan 3 , P Prathiba 3 , M Pitchiahkumar 4 , P Parthiban 5 , K Kanakavalli 6 , P Balaji 3
Affiliation  

Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India’s Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases. A prospective, single-center, open-labeled, randomized, controlled trial was conducted in a COVID Care Centre in Chennai, India. We recruited reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 of 18 to 55 years of age, without clinical symptoms and co-morbidities. They were randomized (1:1 ratio) to KSK (60 mL twice daily for 7 days) or standard of care (7 days supplementation of vitamin C 60,000 IU morning daily and zinc 100 mg evening daily) groups. The primary outcomes were reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR], prevention of progression of asymptomatic to symptomatic state, and changes in the immunity markers including interleukins (IL-6, IL-10, IL-2), interferon gamma (IFNγ), and tumor necrosis factor (TNF α). Siddha clinical assessment and the occurrence of adverse effects were documented as secondary outcomes. Paired t-test was used in statistical analysis. Viral load in terms of the CT value (RdRp: 95% CI = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group. None progressed to the symptomatic state. There was no significant difference in the biochemical parameters. We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups. KSK significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings. Clinical Trial Registry of India CTRI2020/05/025215 . Registered on 16 May 2020

中文翻译:

Kabasura Kudineer (KSK) 是一种多草药 Siddha 药物,与补充维生素 C 和锌相比,可降低无症状 COVID-19 个体的 SARS-CoV-2 病毒载量:前瞻性、探索性、开放标记、比较、随机的结果对照试验,泰米尔纳德邦,印度

尽管在生物医学和传统医学方面做出了多项努力,但截至 2020 年 5 月,还没有针对 2019 年冠状病毒病 (COVID-19) 的药物或疫苗;Kabasura Kudineer (KSK) 是一种来自印度 Siddha 医学系统的多草药制剂,传统上用于与 COVID-19 类似的临床表现。我们探讨了 KSK 在降低无症状 COVID-19 病例的病毒载量和预防疾病进展方面的功效。在印度钦奈的 COVID 护理中心进行了一项前瞻性、单中心、开放标签、随机、对照试验。我们招募了 18 至 55 岁的经逆转录聚合酶链反应 (RT-PCR) 确诊的 COVID-19,没有临床症状和合并症。他们是随机的(1:1 比例)与 KSK(每天两次 60 毫升,持续 7 天)或标准护理(7 天每天早上补充 60,000 IU 维生素 C 和每天晚上 100 毫克锌)组。主要结果是 SARS-CoV-2 负荷减少 [通过 RT-PCR 的循环阈值 (CT) 值衡量]、预防无症状状态发展为有症状状态,以及包括白介素 (IL-6) 在内的免疫标志物的变化、IL-10、IL-2)、干扰素γ(IFNγ)和肿瘤坏死因子(TNFα)。Siddha 临床评估和不良反应的发生被记录为次要结果。配对 t 检验用于统计分析。在第 7 天,KSK 组和对照组的 CT 值(RdRp:95% CI = 1.89 至 5.74)的病毒载量显着下降,在研究组中更为明显。没有人进展到有症状的状态。生化参数无显着差异。我们没有观察到两组基于 Siddha 的临床检查和不良事件的任何变化。KSK 在无症状的 COVID-19 病例中显着降低了 SARS-CoV-2 病毒载量,并且没有记录任何不利影响,表明 KSK 在对抗 COVID-19 的策略中的使用。更大的、多中心的试验可以加强当前的研究结果。印度临床试验注册 CTRI2020/05/025215。2020 年 5 月 16 日注册 表明在针对 COVID-19 的策略中使用了 KSK。更大的、多中心的试验可以加强当前的研究结果。印度临床试验注册 CTRI2020/05/025215。2020 年 5 月 16 日注册 表明在针对 COVID-19 的策略中使用了 KSK。更大的、多中心的试验可以加强当前的研究结果。印度临床试验注册 CTRI2020/05/025215。2020 年 5 月 16 日注册
更新日期:2021-09-15
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