Clinical Study on Tongluo Huatan Capsule for Cerebral Infarction Patients with Syndrome of Phlegm-Stasis Obstructing the Network Vessels in the Recovery Phase
MA Dayong1, HAN Zhenyun2, ZHOU Jie3, et al. Clinical Study on Tongluo Huatan Capsule for Cerebral Infarction Patients with Syndrome of Phlegm-Stasis Obstructing the Network Vessels in the Recovery Phase[J]. Journal of Traditional Chinese Medicine2012, 53(7): 563-567.
MA Dayong1, HAN Zhenyun2, ZHOU Jie3, et al. Clinical Study on Tongluo Huatan Capsule for Cerebral Infarction Patients with Syndrome of Phlegm-Stasis Obstructing the Network Vessels in the Recovery Phase[J]. Journal of Traditional Chinese Medicine2012, 53(7): 563-567.DOI: 10.13288/j.11-2166/r.2012.07.019.
Objective To evaluate the safety and effect of Tongluo Huatan Capsule(c apsule for freeing the network vessels and transforming phlegm) for cerebral inf arction patients of phlegm-stasis obstructing the network vessels syndrome in t h e recovery phase.Methods Multi-centered
randomized
parallel controlled and do uble-blind design was carried out.The selected 479 subjects from seven clinical trial centers were randomized into control group of 121 cases and test group of 358 cases.Tongluo Hu atan Capsule and Xueshuan Xinmaining Capsule(capsule for cerebral thrombosis) w ere given to the test group and control group respectively.The indicators of ef ficacy evaluation included neurological function deficit(NFD) scores
stroke syndrome scores
blood lipid and hemorheology.The indicators of safety evaluation included norma l vital signs
routine examinations of blood
urine
stool
electrocardiogram
l iver function and renal function.Results There were 47 9 subjects enrolled
but 472 subjects finished the trial
with 119 in the control group and 353 in the te st group.Both capsules could significantly improve neurological function and re lieve Chinese medical symptoms.The comprehesive effective rate of NFD and the total effective rate were 22.69% and 71.43% respectively
in the control group
and those in the test group were 37.96% and 84.70% respectively
with significant difference between groups(P<0.01).The total effective rates of r elieving Chinese medical symptoms were 68.91% and 83.85% respectively in the con trol group and test group respectively
with significant difference between grou ps(P<0.01).There was no significant difference in blood lipid and hemorh eology between groups and in group(P>0.05).Conclusion Tongluo Huatan Capsul e could significantly improve neurological function and relieve Chinese medical symptoms for cerebral infarction patients of phlegm-stasis obstructing the netw o rk vessels syndrome in the recovery phase.However
it has not significant effec t in improving blood lipid and hemorheology.In addition
it has a good safety w ithout obvious adverse reactions.