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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087390
Enrollment
Unknown
Registered
2024-07-26
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment in elderly with coronary heart disease

Interventions

The treatment group :Tongxin Yinao granules+ conventional Western medicine treatment
The control group :Tongxin Yinao granules placebo + conventional Western medicine treatment

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Conforms to 2023 by the AHA/ACC/ACCP/ASPC/NLA/PCNA management guidelines for patients with chronic coronary artery disease: clinical practice guidelines, the American heart association/American college of cardiology joint committee report the diagnostic criteria of coronary heart disease; (2) Meet the diagnostic criteria for mild cognitive impairment: Refer to China's 2018 Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment: Diagnostic criteria for the diagnosis and treatment of mild cognitive impairment; (3) According to the Guiding Principles for Clinical Research of New Chinese Medicine and the diagnostic criteria for kidney deficiency and blood stasis syndrome, the TCM syndrome diagnosis criteria for MCI kidney deficiency and blood stasis syndrome in elderly coronary heart disease were formulated, which met the criteria for syndrome differentiation of kidney deficiency and blood stasis syndrome; (4) Age =65 years old and =80 years old, gender is not limited; (5) Visual and auditory resolution is relatively intact, and can cooperate with the completion of relevant assessments; (6) Agreed to participate in the study, the patient signed the informed consent; (7) Those who did not participate in other clinical trials.

Exclusion criteria

Exclusion criteria: (1) Dementia of various causes diagnosed by the DSM-IV criteria for dementia, a history of severe head trauma with persistent neurological deficits or known brain structural abnormalities; (2) persons with previous mental disorders, drug or alcohol abuse or dependence within the previous 5 years; (3) Patients who took Chinese medicines, anticholinergics, anticonvulsants, antiparkinsonics, excitatory drugs, cholinergics, antipsychotics, such as Donepezil, cabalatin, galantamine, huperzine A, which have the effect of tonifying kidney and essence, within 1 month before the test; (4) Patients with severe liver and kidney dysfunction, such as ALT or AST more than 1.5 times the normal value, or creatinine and urea nitrogen more than 1.2 times the normal range, creatinine clearance CrCl < 60 mL/min, coagulation dysfunction and other patients who are not expected to complete the test; (5) Those who have been allergic to the test drug or intolerant to the drug.

Design outcomes

Secondary

MeasureTime frame
TCM syndrome score ;Brachi-ankle pulse wave propagation velocity;Ankle-brachial index;Carotid artery endo-media thickness;Peronea-1 in serum;FGF-21;NLR;

Primary

MeasureTime frame
MoCA Score;Seattle Angina Questionnaire Score;

Countries

China

Contacts

Public ContactFengqin Xu

Xiyuan Hospital, China Academy of Chinese Medical Sciences

doctorxu@aliyun.com+86 188 0002 1979

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026