Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment
Status:
Completed
Trial end date:
2018-05-30
Target enrollment:
Participant gender:
Summary
Qi Zhi Tong Luo (QZTL) capsule, a traditional Chinese herbal medicine, which was used to
treat stoke-related symptoms, include trouble speaking, paralysis and trouble walking. This
study aimed to evaluate the efficacy and safety of QZTL capsule in the treatment of vascular
cognitive impairment. This study was designed as randomized, double-blind, parallel,
placebo-controlled, multicentre trial. It consisted of a single-blind run-in period using
placebo only (2 weeks) and a double-blind treatment phase after randomization (24 weeks), and
follow-up 12 weeks after withdrawal.The primary efficacy variables included changes from
baseline in the Clinical Dementia Rating scale-Sum Box (CDR-SB) and the Mini-mental State
Examination (MMSE) after 24 weeks of treatment. The secondary efficacy measurements include
the Clock Drawing Test (CDT), Hopkins Verbal Learning Test (HVLT) and Ability of Daily Living
(ADL).