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

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ClinicalTrials.gov Identifier: NCT03072225
Recruitment Status : Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carotid Artery Plaque Drug: Herbal Medicine C-117 Drug: The Placebo of Herbal Medicine C-117 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Study on Vulnerable Plaque of Carotid Artery With Chinese Herbal and Insects Medicine
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herbal Medicine

Arm Intervention/treatment
Experimental: Herbal Medicine C-117
Herbal Medicine C-117 Prescription (6g/bag,one bag each time, twice a day.) for 6 months
Drug: Herbal Medicine C-117
Herbal Medicine C-117 formula including 2 herbals and 2 insects

Placebo Comparator: 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
Drug: The Placebo of Herbal Medicine C-117
The Placebo of Herbal Medicine C-117 formula including 4 herbals




Primary Outcome Measures :
  1. The total number of all-cause mortality and all-cause stroke within 12 months [ Time Frame: 1 years ]
    After drug-use 6 months, observe all-cause mortality and all-cause stroke (hemorrhage or ischemic).


Secondary Outcome Measures :
  1. The nature of Vulnerable plaque of carotid artery through color ultrasound [ Time Frame: 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

  2. The number of Vulnerable plaque of carotid artery through color ultrasound [ Time Frame: 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

  3. Blood lipid levels [ Time Frame: 6 months ]
    At the time of 6 months, the investigators will observe the blood lipid levels



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072225


Contacts
Contact: Jianwen Guo, Bachelor 020-81887233 jianwen_guo@msn.com

Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
Principal Investigator: Jianwen Guo, MD Guangdong Province Hospital of Tradtional Chinese Medicine

Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03072225     History of Changes
Other Study ID Numbers: YN2014LN08
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guangzhou University of Traditional Chinese Medicine:
herbal medicine
stroke
vulnerable plaques of carotid artery

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases