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

NCT ID: NCT03072225

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Carotid Artery Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Herbal Medicine C-117

Herbal Medicine C-117 Prescription (6g/bag，one bag each time, twice a day.) for 6 months

Group Type: EXPERIMENTAL

Herbal Medicine C-117

Intervention Type: DRUG

Herbal Medicine C-117 formula including 2 herbals and 2 insects

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

Group Type: PLACEBO_COMPARATOR

The Placebo of Herbal Medicine C-117

Intervention Type: DRUG

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

Interventions

Herbal Medicine C-117

Herbal Medicine C-117 formula including 2 herbals and 2 insects

Intervention Type: DRUG

The Placebo of Herbal Medicine C-117

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianwen Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Province Hospital of Tradtional Chinese Medicine

Central Contacts

Jianwen Guo, Bachelor

Role: CONTACT

jianwen_guo@msn.com

020-81887233

References

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.

Reference Type: DERIVED

PMID: 31391862 (View on PubMed)

Other Identifiers

YN2014LN08

Identifier Type: -

Identifier Source: org_study_id