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Clinical Efficacy Study of Qi-Invigorating, Blood-Circulating, and Phlegm-Resolving Method in Treating Coronary Heart Disease Combined with Carotid Atherosclerosis plaques

Clinical Efficacy Study of Qi-Invigorating, Blood-Circulating, and Phlegm-Resolving Method in Treating Coronary Heart Disease Combined with Carotid Atherosclerosis plaques

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082819
Enrollment
Unknown
Registered
2024-04-09
Start date
2024-03-15
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Coronary heart disease with carotid atherosclerosis

Interventions

treatment group :The Guanxinkang Granules should be taken by dissolving one sachet in 200ml of warm water, and this should be done twice a day. The total duration of usage is 12 weeks.
control group:The placebo should be taken by dissolving one sachet in 200ml of warm water, twice a day. The total duration of usage is 12 weeks.

Sponsors

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with coronary heart disease accompanied by carotid atherosclerosis, meeting both traditional Chinese medicine and Western medicine diagnostic criteria. (2) TCM pattern differentiation indicating qi deficiency and phlegm-blood stasis. (3) Individuals aged 18 and above, but not exceeding 75 years. (4) Sign a informed consent form and commit to compliance with the trial. (5) Women of childbearing age who have been tested to confirm non-pregnancy, and have no plans for pregnancy throughout the entire trial period.

Exclusion criteria

Exclusion criteria: (1) Patients in the acute phase of cardiovascular and cerebrovascular diseases. (2) Those with a history of previous cerebral hemorrhage. (3) Individuals with active ulcers and a tendency to bleed, who are on long-term anticoagulant medication (such as Warfarin). (4) Patients with severe arrhythmias, atrial fibrillation, or heart failure. (5) Patients with concurrent blood system disorders. (6) High-risk patients with indications for stents or surgery. (7) Patients with severe mental disorders (such as autism spectrum disorders, bipolar disorder, schizophrenia, severe depression, etc.) who cannot cooperate with treatment or may affect treatment response. (8) Individuals with allergic tendencies or those who are allergic to the investigational drug, or patients who have experienced severe adverse reactions to the investigational drug. (9) Patients with severe liver or kidney diseases, or significant impairment of liver and kidney function (ALT or AST levels higher than 1.5 times the upper limit of normal, blood creatinine levels higher than 1.5 times the upper limit of normal). (10) Non-compliant patients who cannot meet follow-up requirements.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Questionnaire (SAQ) ;The Crouse Score of Carotid plaque;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Assessment Score;Carotid Intima-Media Thickness (IMT);Frequency of Angina Attacks and Nitroglycerin Usage Reduction Rate;blood lipid levels;Short Form 36 (SF-36);Medical Outcomes Study Sleep Scale (MOS-Sleep);immune-inflammatory markers;

Countries

China

Contacts

Public ContactPing Liu

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Liuping0207@yeah.net+86 21 6438 6430

Outcome results

None listed

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