To Explore The Efficacy Of Naotai Fang In The Treatment Of Hypertensive Cerebral Small Vessel Disease (cerebral White Matter Lesions) Based On The Changes Of Fazekas Score, FIB And Hc

Objective: To observe the clinical efficacy and safety of naotaifang capsules in treating Hypertension with cerebral white matter lesions,and to explore the partial functional mechanism.Methods: This study is a multicenter,randomized,double-blind,placebo-controlled clinical trial.A total of 127 eligible subjects were recruited from the First Hospital of Hunan University of Chinese Medicine from July 2020 to April 2022.After a 4-week run-in period,all participants were divided into the intervention group and control group with a block randomized method.Both groups were given basic treatment such as antihypertensive and lipid reduction,in which the experimental group was given naotaifang capsules and the control group received placebo treatment.These two groups received the treatments for 6 months.The primary outcome included Fazekas scores.Secondary outcome included traditional Chinese medicine(TCM)syndrome scores,mini-mental state examination(MMSE)scale,FIB,Hcy.And safety outcomes such as Blood routine et al.Fazekas scores on magnetic resonance imaging,The traditional Chinese medicine syndrome scores,mini-mental state examination scale,FIB,Hcy and safety outcomes were tested before enrollment and after 6 months of treatment.Results:(1)There was not statistical significant in the improvement of paraventricular and deep WML between two groups.(2)After 6-months treatment,the difference of FIB level was not statistically significant(p> 0.05),the downward trend in the intervention group was better than the control group.(3)The Hcy level increased in two groups,but the increase in the intervention group was less than the control group.(4)Comparing the efficacy of TCM syndrome scores,the difference was not statistically significant,but the efficacy of the intervention group was slightly better than the control group.(5)Comparing the difference before and after treatment in the MMSE scale scores between two groups,the difference was not statistically significant,but the improvement trend in the intervention group was slightly higher than that the control group.(6)The safety index of two groups and within groups was no statistically significant difference between before and after treatment.Conclusion: NTF capsules can delay the progress in cerebral white matter lesions and improve the clinical symptoms of patients,make the brain cognitive function better,and control the rising level of Hcy.This study will generate the evidence on the efficacy and safety of NTF capsules in treating Hypertension with cerebral white matter lesions.Moreover,the results may also help identify the potential mechanism of NTF capsules in treating HT-WML.