A Chinese medicine tablet (Yiqi Huoxue Bushen) for mild cognitive impairment: a study protocol for a multi-center, randomized, double-blind, placebo-controlled clinical trial

Objective: This study aims to evaluate the effectiveness and safety of the traditional Chinese medicine (TCM) Yiqi Huoxue Bushen (YHB) in treating mild cognitive impairment (MCI), and to explore innovative therapeutic approaches for MCI. Methods: This study shows a multi-center, double-blind, randomized controlled clinical experiment. A total of 150 patients will be recruited and randomly allocated to the YHB group or the placebo group at a ratio of 2:1. The treatment duration is six months. The primary outcome is the change in the score of the Alzheimer’s Disease Assessment Scale - Cognitive Subscale (ADAS - Cog). The secondary outcomes include changes in the Activities of Daily Living Scale (ADL), TCM Syndromes Scale, regional homogeneity (ReHo) measured by Resting - state functional magnetic resonance imaging (rs - fMRI), and the composition of the gut microbiota detected by 16S ribosomal ribonucleic acid sequencing. All scales will be assessed at baseline, months 3 and 6, while rs - fMRI and gut microbiota analysis will be conducted at baseline and 6 months. The research study will record and monitor any adverse events (AEs). Conclusion: The findings of this study will provide robust evidence regarding the efficacy and safety of YHB for Mild Cognitive Impairment (MCI), along with insights into a possible mechanism of MCI. Trial enrollment: On March 20, 2022, this clinical study was registered at http://www.chictr.org.cn with the ID: ChiCTR2200057884.