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

Phase 2

• Conditions: Carotid Artery Plaque
• Interventions: Drug: Herbal Medicine C-117; Drug: The Placebo of Herbal Medicine C-117

• Registration Number: NCT03072225
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-18
• Study Start: 2017-03
• Study First Submitted QC: 2017-03-01
• Last Update Submitted: 2017-03-01
• Study First Posted: 2017-03-07
• Last Update Posted: 2017-03-07
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The total number of all-cause mortality and all-cause stroke within 12 months	1 years	After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic).

Secondary Outcome Measures

Name	Time	Method
The number of Vulnerable plaque of carotid artery through color ultrasound	6 months	At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using
The nature of Vulnerable plaque of carotid artery through color ultrasound	6 months	At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using drugs
Blood lipid levels	6 months	At the time of 6 months, the investigators will observe the blood lipid levels