Tongxin Yinao granules for mild cognitive impairment in elderly with coronary heart disease: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Xiyuan Hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新: 2024年7月23日

试验速览

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•(1) Meet the diagnostic criteria for coronary artery disease in the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guidelines for the Management of Patients with Chronic Coronary Artery Disease: a report of the Joint American Heart Association/American College of Cardiology Clinical Practice Guidelines Committee;
•(2) Meet the diagnostic criteria for mild cognitive impairment: refer to China's 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment: Diagnostic Criteria for the Diagnosis and Treatment of Mild Cognitive Impairment;
•(3) To formulate the diagnostic criteria for TCM symptoms of elderly coronary heart disease MCI with renal deficiency and blood stasis with reference to the Guidelines for Clinical Research of New Chinese Medicines and the diagnostic criteria for renal deficiency and blood stasis, and to meet the diagnostic criteria for renal deficiency and blood stasis;
•(2) Age =65 and =80 years old, gender is not limited;
•(3) Visual and auditory discrimination is relatively intact, and they are able to cooperate in completing the relevant assessments;
•(4) Agree to participate in the study and sign the informed consent form;
•(5) Not participating in other clinical trials.

•(1) Dementia of all causes with a diagnosis of DSM-IV diagnostic criteria for dementia, a history of severe head trauma with persistent neurologic deficits or known structural brain abnormalities;
•(2) A history of psychiatric abnormalities, drug or alcohol abuse or dependence within the prior 5 years;
•(3) Patients taking Chinese herbal medicines with tonic effects, anticholinergics, anticonvulsants, antiparkinsonian, excitatory, cholinergic, antipsychotics, such as donepezil, carboplatin, galantamine, and strychnine A, within 1 month prior to the trial;
•(4) Patients with severe hepatic or renal insufficiency, e.g., ALT or AST more than 1.5 times the normal value, or blood creatinine or urea nitrogen more than 1.2 times the normal value range, creatinine clearance CrCl <60 mL/min, coagulation dysfunction, etc. Patients who are expected to be unable to complete the test;
•(5) Patients who have been allergic to the test medication or intolerant to taking medication.

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