Overview
This study is aiming to evaluate the efficacy and safety of Huatuo Zaizao pill in ischemic stroke patients who diagnosed as the phlegm and blood-stasis blocking collaterals syndrome in TCM. A total of 80 subjects will be randomly assigned to Huatuo Zaizao pill group or the control group.
Description
This is a prospective, randomized controlled clinical trial. Eighty patients with phlegm and blood stasis block syndrome of ischemic stroke were randomly assigned to Hua Hua reconstruction group or control group at a ratio of 1:1. The treatment period is 12 weeks. The purpose is to evaluate its efficacy and safety, provide an objective basis for precise treatment of traditional Chinese medicine, and improve clinical efficacy. The main result is the changes of NIHSS, Fugl-Meyer, and MAS 90 days after taking the drug. The secondary result is the change in ADL and TCM symptom scale (CM-SS).
Eligibility
Inclusion Criteria:
- 1.Aged between 35 and 75 years old 2.With a disease course between 2 weeks- 24weeks 3.Meeting the diagnostic criteria of ischemic stroke 4.Meeting the diagnostic criteria of phlegm and blood-stasis blocking collaterals pattern in T traditional Chinese medicine 5.Signed and dated written informed consent. 6.4≤NIHSS score≤22
Exclusion Criteria:
- 1.Unstable vital signs, or serious heart, liver, lung, kidney and other organ diseases 2.Exclude Transient Ischemic Attack(TIA) 3.Patients who are participating in clinical trials of other drugs within the past 1 month 4.Pregnant or breastfeeding women 5.Athletes, Epileptics, Allergic to this product
