Non-inferior-effect single-centered, prospective, randomized controlled trial for Dengzhan Shengmai capsule and aspirin in the treatment of carotid atherosclerosis

Non-inferior-effect single-centered, prospective, randomized controlled trial for Dengzhan Shengmai capsule in the treatment of carotid atherosclerosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021365

Enrollment

Unknown

Registered

2019-02-17

Start date

2019-03-01

Completion date

Unknown

Last updated

2020-07-20

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

Conditions

Carotid atherosclerosis

Interventions

Group 1:Dengzhan Shengmai capsule

Group 2:Aspirin

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Out-patients meeting the diagnostic criteria for carotid atherosclerotic plaques by ultrasound; (2) Carotid ultrasound diagnosis of mild to moderate stenosis (<70%), with stable plaque and no surgical intervention; (3) Aged 18 to 75 years, male and female; (4) Patients who can obtain written informed consent (signed by themselves or legal guardian).

Exclusion criteria

Exclusion criteria: (1) Patients with severe stenosis (>70% ), obvious symptoms, and more than 50% of narrow accompanied with plaque ulcer, requiring surgical or interventional intervention; (2) Those with obvious bleeding tendency; (3) Women who are pregnant or lactating, or women of childbearing age who do not take effective contraceptive measures; (4) Those with known or suspected drug allergy or allergic constitution in this study; (5) Subjects with hemoglobin < 90g/L or platelet < 100x109 /L or WBC < 3.0 x109 /L; (6) Patients with acute cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system; (7) Chest pain caused by severe neurosis, climacteric syndrome, hyperthyroidism, cervical spondylosis, biliary syndrome, gastric and esophageal reflux, hiatal hernia, etc.; (8) Subjects with mental illness who cannot cooperate; (9) Subjects with active infection; (10) Subjects who are participating in other clinical drug research programs or who have completed less than 3 months; (11) Subjects whose life expectancy is shorter than the duration of the test; (12) Subjects considered unsuitable by other researchers.

Design outcomes

Primary

Measure	Time frame
Intima media thickness;	—

Secondary

Measure	Time frame
Carotid plaque area;plaque stability;rate of stenosis;Average lipid level;Mean platelet count;	—

Countries

China

Contacts

Public ContactQu Lefeng

Department of Vascular Surgery, Changzheng Hospital, the Second Military Medical University

qulefeng@163.com+86 18616505267

Outcome results

None listed

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