Treatment of Shengqingtongqiao Decoction for mild cognitive impairment of white matter lesions. Study protocol for a randomized, double-blind, double-dummy, parallel controlled trial

BackgroundWhite matter lesions(WML) is an important cause of mild cognitive impairment(MCI). Ginkgo biloba extracts (GBTs) are widely used to treat cognitive dysfunctions. But the treatment of MCI is still limited. Shenqingtongqiao Decoction(SQTQD), as a clinical empirical formula, has received good feedback in treating MCI of WML. However, there was a lack of solid clinical research on SQTQD in treating MCI. The purpose of this study is to evaluate the efficacy of SQTQD in the MCI patients of WML. MethodsThis is a randomized, double-blind, double-dummy, parallel-controlled trial. 80 participants will be assigned to receive SQTQD granules plus GBTs mimetics or SQTQD mimetic granules plus GBTs in a 1:1 ratio. The trial will last 24 weeks, including a 12-week intervention and 12-week follow-up. The primary outcome is MoCA and AVLT. The secondary outcome is a neuropsychological battery (including MMSE, SCWT, TMT, DST, SDMT, BNT, VFT, and CDT), quality of life(BI, ADL, and FAQ scores), emotion assessment(PHQ-9, GAD-7 score), Fazekas and ARWMCs scale, and fMRI. Researchers will record any adverse events throughout the trial. DiscussionThis study will provide evidence to evaluate the efficacy and safety of SQTQD for MCI of WML compared with GBTs. The trial is registered at Chinese Clinical Trial RegistryChinese Clinical Trial Registry (Number: ChiCTR2300068552)