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

NCT03072225 | Unknown Phase 2 DMC

• 1 other identifier: YN2014LN08
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carotid Artery Plaque

Keywords

herbal medicine; stroke; vulnerable plaques of carotid artery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The nature of Vulnerable plaque of carotid artery through color ultrasound

  6 months

• The number of Vulnerable plaque of carotid artery through color ultrasound

  6 months

• Blood lipid levels

  6 months

Study Arms (2)

Herbal Medicine C-117

EXPERIMENTAL

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

Drug: Herbal Medicine C-117

The Placebo of Herbal Medicine C-117

PLACEBO COMPARATOR

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

Interventions

Herbal Medicine C-117 DRUG

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

Herbal Medicine C-117

The Placebo of Herbal Medicine C-117 DRUG

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

The Placebo of Herbal Medicine C-117

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria of carotid artery atherosclerosis;
• Ultrasound of carotid artery atherosclerosis plaque specifies it as unstable plaque (including malacoplakia and mixed plaque);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Related Publications (1)

• 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.

  PMID: 31391862 DERIVED

MeSH Terms

Conditions

Carotid Stenosis; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianwen Guo, MD

  Guangdong Province Hospital of Tradtional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianwen Guo, Bachelor

CONTACT

020-81887233; jianwen_guo@msn.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: March 7, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share