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A Randomized Controlled Clinical Trial on Huoxue Ruanjian Formula in the Treatment of Carotid Atherosclerosis

A Randomized Controlled Clinical Trial on Huoxue Ruanjian Formula in the Treatment of Carotid Atherosclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000291
Enrollment
Unknown
Registered
2026-02-09
Start date
2023-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Carotid Atherosclerosis

Interventions

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 40-80 years, regardless of gender; (2) Diagnostic criteria for CAS: Conform to Grade I (Carotid IMT =1.0 mm indicates AS [Atherosclerosis] with intima-media thickening) or Grade II (Carotid IMT >1.3 mm with the formation of atherosclerotic plaques, without detected arterial stenosis) as per ultrasonographic diagnostic standards; (3) Diagnosis of Qi Deficiency and Blood Stasis syndrome according to Traditional Chinese Medicine (TCM) pattern differentiation; (4) Patients and their family members are willing to cooperate and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria: (1) Patients with severe carotid artery stenosis (stenosis rate of 70%–99%) or total occlusion requiring stent implantation; (2) Patients with severe primary cerebral or pulmonary diseases, or hepatic/renal insufficiency; (3) Patients with a history of allergy to Chinese herbal medicine; (4) Patients with severe inflammatory diseases; (5) Patients with hemorrhagic diseases; (6) Patients with malignant arrhythmia; (7) Patients with a history of acute cerebrovascular events, acute coronary syndrome, or major trauma within the past 6 months; (8) Patients with hypertensive crisis or emergency; (9) Patients with psychiatric disorders; (10) Pregnant or lactating women; (11) Patients who have participated in other clinical trials within the past month.

Design outcomes

Primary

MeasureTime frame
Carotid Plaque Area;Carotid Intima-Media Thickness;

Secondary

MeasureTime frame
Blood Lipids;Short Form-36 Health Survey (SF-36);TCM Syndrome Scale Score;

Countries

China

Contacts

Public ContactQiMao Feng

Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

741629612@qq.com+86 152 2118 9003

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026