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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03072225
Other study ID # YN2014LN08
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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