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

Carotid Artery Plaque Clinical Trial

— Spchim  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03072225
• Other study ID #: YN2014LN08
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 18, 2017
• Last updated: March 1, 2017
• Start date: March 2017
• Est. completion date: December 2018

Study information

• Verified date: February 2017
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Jianwen Guo, Bachelor
• Phone: 020-81887233
• Email: jianwen_guo[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Plaque
• Carotid Stenosis

Intervention

Drug:
• Herbal Medicine C-117
Herbal Medicine C-117 formula including 2 herbals and 2 insects
• The Placebo of Herbal Medicine C-117
The Placebo of Herbal Medicine C-117 formula including 4 herbals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total number of all-cause mortality and all-cause stroke within 12 months	After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic).	1 years
Secondary	The nature of Vulnerable plaque of carotid artery through color ultrasound	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	6 months
Secondary	The number of Vulnerable plaque of carotid artery through color ultrasound	At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using	6 months
Secondary	Blood lipid levels	At the time of 6 months, the investigators will observe the blood lipid levels	6 months