Shengmai Liquid (Chinese Patent Medicine) for the Treatment of Post-COVID-19 Fatigue: A Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial

Introduction: Fatigue is one of the most common symptoms of post-COVID syndrome. The Chinese herbal medicine Shengmai liquid has been recorded in ancient books, and modern studies have shown its ability to relieve fatigue. This study aims to assess the clinical efficacy and safety of Shengmai liquid in improving fatigue symptoms in post-COVID syndrome patients. Methods: We plan to enroll 100 eligible patients with post-COVID-19 fatigue from Beijing Ditan Hospital, randomly allocating them into either the Shengmai liquid or placebo group. Blinding will be maintained for the personnel responsible for evaluating outcomes and performing statistical analysis. The participants will be treated for 8 weeks and followed for another 30 days. We utilized the modified Fatigue Impact Scale as our main endpoint to evaluate changes in patient fatigue. The secondary outcomes will include the Traditional Chinese Medicine Syndrome Score Scale, Hamilton Depression Inventory-17 items, Hamilton Anxiety Scale, Pittsburgh Sleep Quality Scale, World Health Organization Quality-of-Life Scale, and 6-min walk distance. All the statistical analyses will use SPSS software with a 0.05 significance level and follow the intention-to-treat principle. Conclusion: This randomized, single-center, double-blind trial will provide robust clinical evidence regarding the short-term efficacy and safety of Shengmai liquid for the treatment of post-COVID-19 fatigue.