RESUMO
Objective:To evaluate the safety and effectiveness of Tiandan Tongluo capsule in the treatment of cerebral infarction （CI） in convalescence （stoke involving meridians and collaterals due to wind-phlegm-static blood obstructing vessels）， with Naoshuantong capsule as a control. Method:A total of 352 convalescent patients with CI differentiated into stoke involving meridians and collaterals due to wind-phlegm-static blood obstructing vessels in traditional Chinese medicine （TCM） were included in this multi-center， randomized， double-blind， single-simulated， Naoshuantong capsule-controlled clinical trial， which lasted from 28 December， 2016 to 12 April， 2019. After being randomized into an experimental group and a control group at a ratio of 3∶1， patients in the experimental group were provided with oral Tiandan Tongluo capsule， five capsules per time， three times per day， whereas those in the control group received both Naoshuantong capsule simulator， two capsules per time， three times per day， and Naoshuantong capsule， three capsules per time， three times per day， for 12 successive weeks. The patients were followed up until 180 days after onset. The Barthel activities of daily living （ADL） index （BI） score was used as the primary outcome， and the secondary outcomes included neurological deficit score ［assessed with National Institutes of Health Stroke Scale （NIHSS）］， modified Rankin scale （mRS）， TCM syndrome score， and proportion of patients with new vascular events. The changes in laboratory indexes and the incidence of adverse reactions during treatment were observed. Result:Among the 389 cases enrolled， 30 dropped out， with the drop-out rate being 7.71%. There were 374 cases included in the full analysis set and 377 in the safety set. The comparison with the control group revealed that the total BI score and the percentage of BI score ≥ 75 in the experimental group were increased， but the difference was not statistically significant. The percentage of mRS score ≤ 2 within 180 days after onset in the experimental group obviously elevated in contrast to that of the control group （<italic>P</italic><0.05）. As demonstrated by TCM syndrome score analysis， the markedly effective rate in the experimental group was significantly higher than that in the control group （<italic>P</italic><0.05）. During the trial， the incidence rates of new vascular events in the experimental group and the control group were 0.00% and 1.09% （one case）， respectively， exhibiting no statistically significant difference between the two groups. Conclusion:Tiandan Tongluo capsule and Naoshuantong capsule both produce definite therapeutic effects in the treatment of CI in convalescence （stoke involving meridians and collaterals due to wind-phlegm-static blood obstructing vessels）. Compared with Naoshuantong capsule， Tiandan Tongluo capsule better alleviates neurological deficit， promotes neural functional recovery， and improves TCM syndrome score， without inducing severe adverse reactions.