Department of Clinical Biochemistry, School of Medicine, Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran.
Kondor Pharma Inc, Toronto, Canada.
Inflammopharmacology. 2022 Apr;30(2):465-475. doi: 10.1007/s10787-022-00928-w. Epub 2022 Feb 24.
COVID-19 is a significant global threat to public health. Despite the availability of vaccines and anti-viral drugs, there is an urgent need for alternative treatments to help prevent and/or manage COVID-19 symptoms and the underlying dysregulated immune response. We hypothesized that administration of Inflawell syrup, a Boswellia extract formulation enriched for boswellic acids (BAs), can reduce the excessive or persistent inflammation and thereby prevent disease progression. BAs are medicinally activated triterpenoids found in the resins of Boswellia spp., and possess an immense therapeutic potential due to their anti-inflammatory and immunoregulatory activities. We investigated the effect of Inflawell syrup, on moderate COVID-19 patients along with the current standard of care treatment.
A randomized placebo-controlled double-blind clinical trial was conducted, following definitive confirmation of COVID-19. Forty-seven hospitalized patients with moderate COVID-19 were enrolled and received either the Inflawell syrup or placebo. Clinical symptoms and markers of inflammation were evaluated at baseline and completion of the trial.
Our clinical trial revealed an increase in the percentage of oxygen saturation level in patients that received the BAs compared to placebo (P < 0.0001). In addition, the average duration of hospitalization was significantly shorter in the BAs group compared with the placebo group (P < 0.04). Concomitantly, some improvement in the clinical symptoms including cough, dyspnea, myalgia, headache, and olfactory and gustatory dysfunction were detected in the BAs group. Hematologic findings showed a significant decrease in the percentage of neutrophils (P < 0.006) and neutrophil-to-lymphocyte ratio (NLR) levels (P < 0.003), associated with a significant increase in the percentage of lymphocytes in the BAs group compared with the placebo (P < 0.002). Additionally, a significant decrease in CRP, LDH, IL - 6 and TNF - α levels was detected in the BAs group. Following the intervention, fewer patients in the BAs group were PCR-positive for COVID-19 compared to placebo, though not statistically significant.
Overall, the treatment with Inflawell resulted in shorter hospital stay, alleviation of COVID-19 clinical symptoms and decline in the level of pro-inflammatory cytokines.
The trial has been registered in https://www.irct.ir with unique identifier: IRCT20170315033086N10 ( https://en.irct.ir/trial/51631 ). IRCT is a primary registry in the WHO registry network ( https://www.who.int/clinical-trials-registry-platform/network/primary-registries ).
COVID-19 是对全球公共卫生的重大威胁。尽管有疫苗和抗病毒药物可用，但仍迫切需要替代疗法来帮助预防和/或控制 COVID-19 症状和潜在的失调免疫反应。我们假设，使用富含 Boswellic 酸（BAs）的 Boswellia 提取物制剂 Inflawell 糖浆进行治疗，可以减轻过度或持续的炎症，从而防止疾病进展。BAs 是在 Boswellia spp. 的树脂中发现的药用激活三萜类化合物，由于其抗炎和免疫调节作用，具有巨大的治疗潜力。我们研究了 Inflawell 糖浆对中度 COVID-19 患者的影响，同时也研究了当前的标准治疗方法。
在明确确认 COVID-19 后，进行了一项随机安慰剂对照双盲临床试验。招募了 47 名患有中度 COVID-19 的住院患者，并分别给予 Inflawell 糖浆或安慰剂。在基线和试验完成时评估临床症状和炎症标志物。
我们的临床试验显示，与安慰剂相比，接受 BAs 治疗的患者的血氧饱和度百分比有所增加（P<0.0001）。此外，BAs 组的住院时间明显短于安慰剂组（P<0.04）。同时，在 BAs 组中检测到一些临床症状的改善，包括咳嗽、呼吸困难、肌痛、头痛以及嗅觉和味觉功能障碍。血液学发现中性粒细胞百分比（P<0.006）和中性粒细胞与淋巴细胞比值（NLR）水平（P<0.003）显著下降，与 BAs 组中淋巴细胞百分比显著增加（P<0.002）相关。此外，BAs 组中 CRP、LDH、IL-6 和 TNF-α 水平也显著下降。干预后，与安慰剂相比，BAs 组中 PCR 检测到 COVID-19 阳性的患者更少，但无统计学意义。
总体而言，使用 Inflawell 治疗可缩短住院时间，缓解 COVID-19 临床症状，并降低促炎细胞因子水平。
该试验已在 https://www.irct.ir 上注册，唯一标识符为：IRCT20170315033086N10（https://en.irct.ir/trial/51631）。IRCT 是世卫组织注册网络中的主要注册机构（https://www.who.int/clinical-trials-registry-platform/network/primary-registries）。
