To evaluate the effect of the dynamic combination therapy on Chinese herbal granule formula (Fangji) based on differentiation of syndromes ("Zhenghou") according to the theory of traditional Chinese medicine for improving the symptoms in the convalescent phase of ischemic stroke, and to establish the pharmacodynamic model of "Zhenghou" according to the results of this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
After evaluated the style of the syndrome (Zhenghou) by an experienced integrative medicine doctor, the patients should be given a Chinese herbal granule formula twice a day for 4 weeks, which should be selected from 10 kinds of Chinese herbal granules and weekly changed according to differentiation of syndromes (Zhenghou) of patients.
The 10 kinds of matched placebo granules were of the similar appearance, taste, smell with the corresponding Chinese herbal granules respectively. The interventional process of the placebo group is similar as the Chinese herbal granule formula group
Standard medical care is the basic treatment for all enrolled patients, including aspirin 75-100mg per day, standard rehabilitation training, treatment for their primary diseases, etc.
The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
Guiyang, Guizhou, China
Symptom Scale of the "Qixu-Xueyu Zheng"(Qi Deficiency and Blood Stasis Syndrome) according to the theory of Traditional Chinese Medicine at Day 28
Time frame: Day 28
Bathel Index
Time frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
modified Rankin Scale
Time frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
NIH stroke scale(NIHSS)
Time frame: Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset
EQ-5D scale
Time frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
Overall mortality at day 90
Time frame: Day 90 after onset
Incidence of Recurrent Stroke
Time frame: Day 90 after onset this time
Incidence of new-onset vascular events
Time frame: Day 90 after onset this time
Incidence of adverse events (AEs) and serious AEs
Time frame: From Day 0 to Day 90 after onset
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.