A multi-center, prospective, open-label, end-point blinding, randomized controlled clinical study of Maiguan Fukang tablets in patients with mild to moderate carotid stenosis

Category Primary study
Registry of TrialsITMCTR
Year 2022
INTERVENTION: Controled group:Lifestyle adjustment (diet, exercise and/or other systemic drugs) ;Experimental group:Lifestyle adjustment (diet, exercise and/or other systemic drugs) + Maiguan Fukang tablets 4 tablets /time, 3 times /day; CONDITION: mild to moderate carotid stenosis PRIMARY OUTCOME: Mean IMT of common carotid artery; SECONDARY OUTCOME: Mean IMT of extracranial internal carotid artery;resistance inde Xof carotid artery;End‐diastolic flow rate of carotid artery;Carotid artery stenosis rate;Mean IMT of carotid bulb;peak systolic velocity of carotid artery;Carotid plaque area;Carotid plaque size;Blood lipids;Total score of bilateral carotid plaque ;TCM Syndrome Score of Blood Stasis Syndrome;Maximum IMT of common carotid artery;hs‐CRP;Seattle Angina Questionnaire;Maximum IMT of carotid bulb;Maximum IMT of extracranial internal carotid artery; INCLUSION CRITERIA: (1) Meet with western medical diagnostic criteria for mild to moderate carotid artery stenosis (stenosis rate <50%, confirmed by cerebral angiography or CTA or MRA or non‐invasive examination, refer to the guidelines for the diagnosis and treatment of carotid stenosis and the guidelines for vascular ultrasonography in stroke in China); (2) Meet the diagnostic criteria of blood stasis syndrome in traditional Chinese medicine (refer to the "Practical Diagnostic Criteria of Blood Stasis Syndrome" by the Chinese Society of Integrative Medicine); (3) Ultrasonography revealed that the carotid artery intima‐media is thickened (IMT=1.2mm), and the carotid artery plaques are iso‐echoic plaques or mixed‐echo plaques; (4) The 10‐year cardiovascular disease risk is less than 5%; (5) Adult patients are aged 18‐70 (no gender limit, including 18‐year‐old and 70‐year‐old patients); (6) Informed and signed informed consent form.
Epistemonikos ID: 48ebe9361966c61cd413ccccc2f72dbdc7bd7862
First added on: Aug 26, 2024