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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
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    February 18, 2017
    Last Updated
    March 1, 2017
    Sponsor
    Guangzhou University of Traditional Chinese Medicine
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    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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