Herbal Medicines for Post-Acute Sequelae (Fatigue or Cognitive Dysfunction) of SARS-CoV-2 Infection: A Phase 2 Pilot Clinical Study Protocol

Abstract

Long-term sequelae refer to persistent symptoms or signs for >6 months after SARS-CoV-2 infection. The most common symptoms of sequelae are fatigue and neuropsychiatric symptoms (concentration difficulty, amnesia, cognitive dysfunction, anxiety, and depression). However, approved treatments have not been fully established. Herbal medicines are administered for 12 weeks to patients who continuously complain of fatigue or cognitive dysfunction for >4 weeks that only occurred after COVID-19 diagnoses. Based on the Korean Medicine syndrome differentiation diagnosis, patients with fatigue will be administered Bojungikgi-tang or Kyungok-go, whereas those with cognitive dysfunction will be administered Cheonwangbosim-dan. Results could support evidence that herbal medicines may mitigate fatigue and cognitive dysfunction caused by COVID-19. Furthermore, by investigating the effects of herbal medicines on changes in metabolite and immune response due to COVID-19, which may be responsible for sequelae, the potential of herbal medicines as one of the therapeutic interventions for post-acute sequelae of SARS-CoV-2 infection can be evaluated. Therefore, the effects of herbal medicine on fatigue and cognitive dysfunction sequelae due to COVID-19 will be elucidated in this study to provide an insight into the preparation of medical management for the post-acute sequelae of SARS-CoV-2 infection.

Effect and mechanism of quercetin or quercetin‐containing formulas against COVID‐19: From bench to bedside

“…Recently, herbal medicine has emerged as a potential treatment option for addressing the long‐term effects of COVID‐19, particularly fatigue and cognitive dysfunction (Jegal et al, 2022). A retrospective descriptive study highlights the frequent prescription of Hochuekkito (Bu‐Zhong‐Yi‐Qi‐Tang, TJ‐41) in Kampo medicine for managing post‐COVID fatigue (Tokumasu et al, 2022).…”

Herbal Medicines for Long COVID: A Phase 2 Pilot Clinical Study

“…This study was approved by the Institutional Review Board of Kyung Hee University KM Hospital (KOMCIRB 2020-12-002-001). The protocol of this study was published as a protocol paper [18] and registered at cris.nih.go.kr (KCT0006252) prior to the start of the clinical trial.…”

“…AEs were assessed at all in-person visits occurring at 1, 5, 9, 13, 25, and 37 weeks. Detailed research methodology can be found in the previously published protocol paper [18].…”

Management of asymptomatic to mild COVID-19 patients with Cheongpebaedok-tang on the telemedical basis: A retrospective observational case series

“…Several studies have purported that herbal medicines are effective in improving symptoms, lung function, and imaging in mild cases and in the management of COVID-19 sequelae. 25,26) Given that clinical trials have been registered and are recruiting, 27,28) it is expected that additional well-designed large-scale clinical studies will be published in the near future. 29) Despite the similarities in recruitment timeframe and symptom severity, none of the patients included in this study were admitted to a hospital due to worsening COVID-19 symptoms.…”