A randomized, double-blind, double-simulated, parallel controlled, multi-center, three-arm clinical trial was conducted to evaluate the efficacy and safety of Tiantan Tongluo tablet in the treatment of ischemic stroke (syndrome of meridians and collaterals, wind phlegm blood stasis and obstruction of veins in stroke)

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Test group:Tiandan Tongluo tablets, 5 tablets/time, 3 times/day; by mouth. Xiaoshuan Tongluo tablet simulation tablet, 6 tablets/time, 3 times/day; by mouth.;Placebo group:Tiandan Tongluo tablet simulation tablet, 5 tablets/time, 3 times/day; By mouth. Xiaoshuan Tongluo tablet simulation tablet, 6 tablets/time, 3 times/day; By mouth.;Positive drug group:Xiaoshuantongluo tablet, 6 tablets/time, 3 times/day; By mouth. Tiandan Tongluo tablet simulation tablet, 5 tablets/time, 3 times/day; By mouth.; CONDITION: Acute ischemic stroke PRIMARY OUTCOME: Change in NIHSS score from baseline ; SECONDARY OUTCOME: Percentage of mRS Score <= 1 point, <= 2 points and score change from baseline ;The percentage of subjects with Barthel inde Xscore >= 75 and >= 95 and the change of score from baseline;Change value of NIHSS score, proportion of NIHSS score <= 1 point, proportion of NIHSS score decreased by >= 4 points, and change value of NIHSS score from baseline;The change value of TCM syndrome efficacy, total score and individual score compared with baseline ;Change from baseline in post‐stroke symptom grading scores ;The changes in the severity of each symptom and the disappearance rate of each symptom in the stroke syndrome factor evaluation scale were compared with the baseline at 14, 30, 60 and 90 days after treatment;The changes of DHI scores compared with baseline;Proportion of patients with new cerebrovascular events at 14, 30, 60, and 90 days after treatment;Change in MoCA score from baseline ;Changes in EQ‐5D scores from baseline; INCLUSION CRITERIA: 1. Aged 18‐75 years old; 2. In line with Western diagnostic criteria for acute ischemic stroke; 3. TCM syndrome differentiation is meridians and collaterals of stroke, wind phlegm and blood stasis and obstruction of veins; 4. Patients with first onset or good recovery after last onset (modified Rankin scale score 0‐1); 5. Patients with duration <= 7 days <= 30 days; 6. National Institutes of Health Stroke Scale (NIHSS) score 4‐22; 7. Voluntary informed consent.
Epistemonikos ID: ee1b3e8b4c21f7b1d3a7bec0ea31bc7abb6212e5
First added on: Feb 20, 2024