Khapre Minakshi, Pathania Monika, Saxena Vartika, Omar Balram Ji, Goyal Bela, Sinha Smita, Bahurupi Yogesh, Dhamija Puneet
Department of CFM, AIIMS Rishikesh India.
Department of Internal Medicine, AIIMS Rishikesh India.
J Ayurveda Integr Med. 2023 Jul-Aug;14(4):100777. doi: 10.1016/j.jaim.2023.100777. Epub 2023 Aug 1.
COVID-19 was declared a pandemic in 2020. It has had a devastating effect on human life and the global economy. To date, there is no proven therapy for COVID-19, even though rigorous research is ongoing to test multiple compounds across all systems of medicine. A need was felt to systematically explore the Indian system of medicine to assess its efficacy against COVID-19. The objective of the present study was to examine the effect of Kabasura Kudineer as a standalone therapy on the following: time required to achieve symptom relief & resolution, virological clearance, and levels of IL6, CRP and IgG, and compare it to the standard therapy available for treatment of COVID-19.
A double-blinded randomized controlled trial was conducted in 110 participants. 55 participants were enrolled in the Kabasura Kudineer arm and 55 in the control (standard therapy + Kabasura Kudineer placebo) arm. Study participants were randomly allocated into the two study arms. They were assessed for symptoms at baseline, and on Day 5 and Day 10. RT PCR, CRP, IL6 and IgG levels were measured at baseline, Day 5 and Day 10. On day 28, participants were interviewed telephonically for symptom assessment alone.
A per-protocol approach was used. Significant difference between two groups was assessed at baseline, day 5 and day 10 using the Chi-square and Mann Whitney test.
A total of 110 patients participated in study. Four patients in the Kabasura Kudineer arm and 9 in the Standard therapy arm were lost to follow-up. Baseline characteristics for both the groups were matched at baseline. 83.9% and 93.9% patients were relieved of all symptoms by the 10th day in Kabasura and standard therapy groups respectively. Decrease in CRP level was more pronounced in the Kabasura group compared to standard therapy viz. 3 mg/l and 1.26 mg/l. No significant difference was found in IgG level and IL6 levels in both the study groups. However, it was noticed that among the unvaccinated group, the surge in IgG levels was much higher in Kabasura Kudineer group than the standard therapy group.
Kabasura Kudineer as a standalone therapy was as effective and safe as the standard therapy among patients with asymptomatic to mild COVID-19.
2020年，新型冠状病毒肺炎（COVID-19）被宣布为大流行病。它对人类生活和全球经济造成了毁灭性影响。迄今为止，尚无经证实的COVID-19治疗方法，尽管正在进行严格研究以测试所有医学体系中的多种化合物。人们感到有必要系统地探索印度医学体系，以评估其对COVID-19的疗效。本研究的目的是检验卡巴萨拉库迪尼尔（Kabasura Kudineer）作为单一疗法对以下方面的影响：实现症状缓解和消除所需的时间、病毒学清除情况以及白细胞介素6（IL6）、C反应蛋白（CRP）和免疫球蛋白G（IgG）水平，并将其与可用于治疗COVID-19的标准疗法进行比较。
对110名参与者进行了一项双盲随机对照试验。55名参与者被纳入卡巴萨拉库迪尼尔组，55名被纳入对照组（标准疗法 + 卡巴萨拉库迪尼尔安慰剂）。研究参与者被随机分配到两个研究组。在基线、第5天和第10天对他们进行症状评估。在基线、第5天和第10天测量逆转录聚合酶链反应（RT PCR）、CRP、IL6和IgG水平。在第28天，通过电话对参与者进行单独的症状评估访谈。
采用符合方案分析方法。使用卡方检验和曼-惠特尼检验在基线、第5天和第10天评估两组之间的显著差异。
共有110名患者参与研究。卡巴萨拉库迪尼尔组有4名患者、标准疗法组有9名患者失访。两组的基线特征在基线时匹配。在卡巴萨拉库迪尼尔组和标准疗法组中，分别有83.9%和93.9%的患者在第10天时所有症状得到缓解。与标准疗法相比，卡巴萨拉库迪尼尔组CRP水平的下降更为明显，分别为3毫克/升和1.26毫克/升。两个研究组的IgG水平和IL6水平均未发现显著差异。然而，注意到在未接种疫苗的组中，卡巴萨拉库迪尼尔组的IgG水平升高幅度远高于标准疗法组。
在无症状至轻度COVID-19患者中，卡巴萨拉库迪尼尔作为单一疗法与标准疗法一样有效且安全。
