背景:COVID-19的发病机制包括综合免疫-炎症反应。调节宿主针对SARS-CoV-2病毒的免疫应答可能是有效的治疗管理。各种Unani制剂具有免疫调节作用。
目的:探讨乌纳尼复方药物(TiryaqWabai)对COVID-19患者的免疫调节作用和安全性。
方法:本研究是一项随机安慰剂对照临床试验,包括92名轻中度COVID-19患者,随机分为两组。Unani配方TiryaqWabai(每天一次口服2克)用作干预45天,而对照组接受安慰剂。两组均接受标准护理治疗。主要结果是绝对淋巴细胞计数(ALC)增加50%。次要结果是平均淋巴细胞百分比增加50%,CD4细胞,和CD8细胞计数。还研究了所有上述参数的平均增加。采用相关统计学检验对效果进行分析。
结果:ALC增加50%的统计学显着改善(p值,0.004),淋巴细胞百分比(p值,0.056),CD4(p值,0.005),和CD8细胞计数(p值,0.050)被报告。此外,淋巴细胞百分比的平均值显着改善(p值0.0007),ALC(p值0.0022),CD4细胞计数(p值0.0025),治疗后观察到CD8细胞计数(p值0.0093)。在安慰剂组中报告了一个轻度不良事件。两组的安全性参数分析(LFT和KFT)均正常。
结论:在轻中度COVID-19患者中,TiryaqWabai通过改善ALC计数有效地显示免疫调节活性,淋巴细胞百分比,CD4和CD8细胞计数。
BACKGROUND: The pathogenesis of COVID-19 includes an integrated immune-inflammatory response. Modulation of host immune responses against the SARS-CoV-2 virus might be effective therapeutic management. Various Unani formulations have an immunomodulatory effect.
OBJECTIVE: To explore the immunomodulatory effect and safety of Unani polyherbal drug (Tiryaq Wabai) in COVID-19 patients.
METHODS: The current study was a randomized placebo-controlled clinical trial that included 92 mild to moderate COVID-19 patients randomized into two groups. The Unani formulation Tiryaq Wabai (2 gm orally once a day) was used as an intervention for 45 days, while the control group received a placebo. Both groups received standard care treatment. The primary outcome was 50% increment in absolute lymphocyte count (ALC). The secondary outcome was 50% increment in mean lymphocyte percentage, CD4 cells, and CD8 cell count. The mean increase in all the above parameters has also been studied. Relevant statistical tests were used to analyze the effect.
RESULTS: A statistically significant improvement in a 50% increase in ALC (p-value, 0.004), lymphocyte percentage (p-value, 0.056), CD4 (p-value, 0.005), and CD8 cell count (p-value, 0.050) was reported. Also, a significant improvement in the mean value of the lymphocyte percentage (p-value 0.0007), ALC (p-value 0.0022), CD4 cell count (p-value 0.0025), and CD8 cell count (p-value 0.0093) was observed after the treatment. One adverse event of mild grade was reported in the placebo group. The analysis of safety parameters (LFT and KFT) was normal for both groups.
CONCLUSIONS: In mild to moderate COVID-19 patients, Tiryaq Wabai effectively showed immunomodulatory activity by improving ALC count, lymphocyte percentage, CD4, and CD8 cell count.