Efficacy and safety of Yi wei Huang qi Decoction for Carotid Atherosclerotic Plaque Ulcer: study protocol for a randomized double-blind placebocontrolled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300071512

Enrollment

Unknown

Registered

2023-05-17

Start date

2023-05-31

Completion date

Unknown

Last updated

2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Atherosclerotic Plaque Ulcer

Interventions

Test group:Yi wei Huang qi Decoction

Control group::Yi wei Huang qi Decoction placebo

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with carotid atherosclerotic plaque ulcer diagnosed by color Doppler ultrasound and HRMRI; (2) Conforming to the diagnosis of qi deficiency and toxin stagnation; (3) Age range from 40 to 80, regardless of gender; (4) Lumen stenosis<70%; (5) Those who can persist in taking medicine for a long time; (6) The patient has informed consent and signed the informed consent form

Exclusion criteria

Exclusion criteria: (1) Patients with acute cardiovascular and cerebrovascular diseases; (2) Previous history of cerebral hemorrhage; (3) Active ulcer and bleeding tendency, long-term use of anticoagulant drugs (such as warfarin); (4) Patients with severe arrhythmia, atrial fibrillation and heart failure; (5) Have serious heart,liver,kidney,hematopoietic system,endocrine system, respiratory system and other primary diseases, and the liver function is more than 1.5 times higher than the upper limit of normal value; (6) Pregnant or lactating women; (7) Allergic constitution; (8) Other diseases or psychosis that the investigator thinks may limit the efficacy evaluation or patient follow-up; (9) Patients who have participated in clinical trials of other drugs in recent 4 weeks.

Design outcomes

Primary

Measure	Time frame
Ulcer disappearance rate;The number of ulcers was changed;Body weight, blood lipid and blood pressure ;	—

Secondary

Measure	Time frame
The improvement rate of ulcer shrinkage with clinical significance;The change of the maximum ulcer length;The maximum change of ulcer depth;The changes of Qi deficiency and toxin stagnation syndrome;The average onset time and average recovery time of syndromes. ;The thickness of the largest plaque;The area of the largest plaque;The thickness of the inner and middle membrane;	—

Countries

China

Contacts

Public ContactWuSheng xian

Dongzhimen Hospital,Beijing University of Chinese Medicine

wushx@sina.com+86 10 8401 5528

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026