Impact of combined plant extracts on long COVID: An exploratory randomized controlled trial.

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2024-10-31 DOI:10.1016/j.ctim.2024.103107

Thitiya Lukkunaprasit, Patompong Satapornpong, Pongsiri Kulchanawichien, Abhisit Prawang, Chaiwat Limprasert, Worawan Saingam, Chatpetch Permsombut, Wongvarit Panidthananon, Arthimond Vutthipong, Yupin Lawanprasert, Parnthep Pourpongpan, Supakit Wongwiwatthananukit, Thanapat Songsak, Nalinee Pradubyat

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Abstract

Background: Long COVID have posed a global health burden since the COVID-19 pandemic. This study aimed to evaluate the efficacy and safety of a combined plant extract (CPE) formulation, containing Citrus aurantifolia, Tiliacora triandra, Cannabis sativa, Alpinia galanga, and Piper nigrum, in participants with long COVID. A newly developed long COVID symptom questionnaire was used to evaluate outcomes.

Methods: This randomized, double-blinded, placebo-controlled trial was conducted at the College of Pharmacy, Rangsit University, Thailand. Participants were randomly assigned to receive either a CPE supplement (4500 mg/day) or a placebo for 7 days. Primary outcomes were changes in C-reactive protein (CRP) levels and the total symptom score (ranging from 0 to 57 points). Secondary outcomes included full recovery/improvement of long COVID symptoms, health-related quality of life (HRQOL), and adverse events.

Results: A total of 66 participants were enrolled, with 33 in each group. The CPE supplement did not significantly reduce CRP levels, with a median difference (MD) (95 % CI) of -0.05 (-0.49, 0.39) mg/L compared to placebo. However, the CPE group showed a reduction in the total symptom score [MD (95 % CI) of -4.00 (-7.58, -0.42)], and a reduction in overall moderate to severe symptoms [RR (95 % CI) of 0.57 (0.35, 0.91)], moderate to severe fatigue [RR (95 % CI) of 0.25 (0.08, 0.81)], and moderate to severe post-exertional malaise (PEM) [RR (95 % CI) of 0.35 (0.16, 0.78)]. Changes in HRQOL scores did not differ significantly between groups. Adverse events were mostly mild and resolved by the end of the follow-up period.

Conclusions: Our study suggests potential benefits of the CPE in alleviating moderate to severe long COVID symptoms, particularly fatigue and PEM, with an acceptable safety profile. However, larger-scale trials are necessary to validate these findings, and assessing the reliability of the long COVID symptom questionnaire is essential before its application in future studies.

Trial registration number: TCTR20230131004 (Registration date: 2023-01-31, Thai Clinical Trials Registry).

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综合植物提取物对长期 COVID 的影响：一项探索性随机对照试验。

背景：自 COVID-19 大流行以来，长效 COVID 已成为全球健康负担。本研究旨在评估含有枳实、三棱草、大麻、高山植物和胡椒的植物提取物（CPE）组合配方对长期慢性阻塞性肺病患者的疗效和安全性。新开发的长COVID症状问卷用于评估结果：这项随机、双盲、安慰剂对照试验在泰国兰实大学药学院进行。参与者被随机分配接受 CPE 补充剂（4,500 毫克/天）或安慰剂，为期 7 天。主要结果是 C 反应蛋白 (CRP) 水平和症状总分（从 0 分到 57 分不等）的变化。次要结果包括COVID长期症状的完全恢复/改善、与健康相关的生活质量（HRQOL）和不良事件：结果：共有 66 人参加了研究，每组 33 人。与安慰剂相比，CPE补充剂并未明显降低CRP水平，中位数差异（MD）（95% CI）为-0.05 (-0.49, 0.39) mg/L。不过，CPE 组的症状总分有所降低[MD（95% CI）为 -4.00 (-7.58, -0.42)]，中重度症状[RR（95% CI）为 0.57 (0.35, 0.91)]、中重度疲劳[RR（95% CI）为 0.25 (0.08, 0.81)]和中重度劳累后乏力 (PEM) [RR (95% CI) 为 0.35 (0.16, 0.78)]的总体症状有所降低。各组间的 HRQOL 评分变化无显著差异。不良反应大多较轻，并在随访期结束时得到缓解：我们的研究表明，CPE 在缓解中度至重度长期 COVID 症状（尤其是疲劳和 PEM）方面具有潜在的益处，且安全性可接受。然而，有必要进行更大规模的试验来验证这些研究结果，而且在将长COVID症状问卷应用于未来的研究之前，必须对其可靠性进行评估。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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