Shengmai Liquid (Chinese patent medicine) for the treatment of post-COVID-19 fatigue: A protocol for a randomized, double-blind, placebo-controlled trial

Background 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. Objective This study aimed to assess the clinical efficacy and safety of Shengmai liquid in improving fatigue symptoms in post-COVID syndrome patients. Methods and analysis We plan to collect 100 eligible patients with post-COVID-19 fatigue from Beijing Ditan Hospital and randomly divided them into Shengmai liquid or placebo groups. The participants, clinical practitioners, outcome assessors and statisticians will be blinded during the treatment and data analysis. The participants will be treated for 8 weeks and followed for another 30 days. The primary outcome was the modified Fatigue Impact Scale score. The secondary outcomes included 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 six-minute walk distance. All the statistical analyses will use SPSS software with a 0.05 significance level and follow the intention-to-treat (ITT) principle. Discussion This single-center, randomized, double-blind trial rigorously evaluated the safety and efficacy of Shengmai liquid for the treatment of post-COVID-19 fatigue. A key strength is the comprehensive assessment of outcomes and a one-month follow-up to determine short-term effects. A limitation is the single-center design, which may affect generalizability, but the results will provide valuable clinical evidence and be shared via publication and trial registration.