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

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

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.

Study Overview

• Status: Unknown
• Conditions: Carotid Artery Plaque
• Intervention / Treatment: Drug: Herbal Medicine C-117; Drug: The Placebo of Herbal Medicine C-117

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
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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	6 months
Blood lipid levels	At the time of 6 months, the investigators will observe the blood lipid levels	6 months

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Jianwen Guo, MD, Guangdong Province Hospital of Tradtional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 18, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: stroke; herbal medicine; vulnerable plaques of carotid artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: YN2014LN08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No