Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine (Spchim)

Guangzhou University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Carotid Artery Plaque

Treatments: Drug: Herbal Medicine C-117; Drug: The Placebo of Herbal Medicine C-117

Study type: Interventional

Funder types: Other

Identifiers

NCT03072225

YN2014LN08

Details and patient eligibility

About

The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects Chinese medicine. Designing a RCT trial to prove the effect and safety.

Full description

Vulnerable plaque of carotid artery is the important intervention target for primary prevention and secondary prevention of cerebral arterial thrombosis, but there are no effective, safe and prevalent treatment measures against it. The development that traditional Chinese medicine has achieved in treating plaque of carotid artery shows that great accomplishment could be made within this area. Academia should engage in clinical research on regulated treatment methods in traditional Chinese medicine with long-term intervention and high patient compliance, providing strong evidence for evidence-based medicine and guidance to clinical practice.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the diagnostic criteria of carotid artery atherosclerosis;
2. Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);

Exclusion criteria

1. mRS Rating higher than or equal to 3 before joining the trail group;
2. Carotid artery stenosis is higher than or equal to 50%;
3. Confirmed as or suspected to be vasculitis;
4. With infection, tumor or insufficient heart, liver and kidney functions (renal function higher than twice of upper limit in normal limit, HYHA heart function grading higher than or equal to level 2 );
5. With acute myocardial infarction and unstable angina pectoris;
6. With acute cerebral arterial thrombosis;
7. lesion: Severe stenosis or occlusion of distal intracranial vessels;
8. Pregnant women or lactating mothers;
9. With known history of allergy to the drugs of the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Herbal Medicine C-117

Experimental group

Description:

Herbal Medicine C-117 Prescription (6g/bag，one bag each time, twice a day.) for 6 months

Treatment:

Drug: Herbal Medicine C-117

The Placebo of Herbal Medicine C-117

Placebo Comparator group

Description:

Placebo of Herbal Medicine C-117 (6g/bag，one bag each time, twice a day.) for 6 months

Treatment:

Drug: The Placebo of Herbal Medicine C-117