Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine (Spchim)
Primary Purpose
Carotid Artery Plaque
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Herbal Medicine C-117
The Placebo of Herbal Medicine C-117
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Plaque focused on measuring herbal medicine, stroke, vulnerable plaques of carotid artery
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnostic criteria of carotid artery atherosclerosis;
- Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);
Exclusion Criteria:
- mRS Rating higher than or equal to 3 before joining the trail group;
- Carotid artery stenosis is higher than or equal to 50%;
- Confirmed as or suspected to be vasculitis;
- 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 );
- With acute myocardial infarction and unstable angina pectoris;
- With acute cerebral arterial thrombosis;
- lesion: Severe stenosis or occlusion of distal intracranial vessels;
- Pregnant women or lactating mothers;
- With known history of allergy to the drugs of the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Herbal Medicine C-117
The Placebo of Herbal Medicine C-117
Arm Description
Herbal Medicine C-117 Prescription (6g/bag,one bag each time, twice a day.) for 6 months
Placebo of Herbal Medicine C-117 (6g/bag,one bag each time, twice a day.) for 6 months
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
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
Blood lipid levels
At the time of 6 months, the investigators will observe the blood lipid levels
Full Information
NCT ID
NCT03072225
First Posted
February 18, 2017
Last Updated
March 1, 2017
Sponsor
Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03072225
Brief Title
Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
Acronym
Spchim
Official Title
Randomized Controlled Clinical Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Plaque
Keywords
herbal medicine, stroke, vulnerable plaques of carotid artery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Herbal Medicine C-117
Arm Type
Experimental
Arm Description
Herbal Medicine C-117 Prescription (6g/bag,one bag each time, twice a day.) for 6 months
Arm Title
The Placebo of Herbal Medicine C-117
Arm Type
Placebo Comparator
Arm Description
Placebo of Herbal Medicine C-117 (6g/bag,one bag each time, twice a day.) for 6 months
Intervention Type
Drug
Intervention Name(s)
Herbal Medicine C-117
Intervention Description
Herbal Medicine C-117 formula including 2 herbals and 2 insects
Intervention Type
Drug
Intervention Name(s)
The Placebo of Herbal Medicine C-117
Intervention Description
The Placebo of Herbal Medicine C-117 formula including 4 herbals
Primary Outcome Measure Information:
Title
The total number of all-cause mortality and all-cause stroke within 12 months
Description
After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic).
Time Frame
1 years
Secondary Outcome Measure Information:
Title
The nature of Vulnerable plaque of carotid artery through color ultrasound
Description
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
Time Frame
6 months
Title
The number of Vulnerable plaque of carotid artery through color ultrasound
Description
At the time of 6 months, observe the nature of Vulnerable plaque of carotid artery through color ultrasound, comparing with the result before using
Time Frame
6 months
Title
Blood lipid levels
Description
At the time of 6 months, the investigators will observe the blood lipid levels
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the diagnostic criteria of carotid artery atherosclerosis;
Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);
Exclusion Criteria:
mRS Rating higher than or equal to 3 before joining the trail group;
Carotid artery stenosis is higher than or equal to 50%;
Confirmed as or suspected to be vasculitis;
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 );
With acute myocardial infarction and unstable angina pectoris;
With acute cerebral arterial thrombosis;
lesion: Severe stenosis or occlusion of distal intracranial vessels;
Pregnant women or lactating mothers;
With known history of allergy to the drugs of the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianwen Guo, Bachelor
Phone
020-81887233
Email
jianwen_guo@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwen Guo, MD
Organizational Affiliation
Guangdong Province Hospital of Tradtional Chinese Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31391862
Citation
Gong B, Chen X, Lin R, Zhang F, Zhong J, Zhang Q, Zhou Y, Li H, Zeng L, Jiang Z, Guo J. Safety and Efficacy of the C-117 Formula for Vulnerable Carotid Artery Plaques (Spchim): A Randomized Double-Blind Controlled Pilot Study. Evid Based Complement Alternat Med. 2019 Jul 17;2019:9746492. doi: 10.1155/2019/9746492. eCollection 2019.
Results Reference
derived
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Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
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