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Jiangzhi Tongluo soft capsules for the treatment of primary hyperlipidemia (qi stagnation and blood stasis syndrome)Effectiveness and safety of randomized, double-blind, double-dummy, positive drug parallel control, multicenter clinical trial

Jiangzhi Tongluo soft capsules for the treatment of primary hyperlipidemia (qi stagnation and blood stasis syndrome)Effectiveness and safety of randomized, double-blind, double-dummy, positive drug parallel control, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014435
Enrollment
Unknown
Registered
2018-01-13
Start date
2016-02-03
Completion date
Unknown
Last updated
2018-01-15

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

Conditions

Primary hyperlipidemia

Interventions

treatment group:Jiangzhi Tongluo soft capsules
control group:Pushen capsules

Sponsors

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Meet the criteria of Western diagnosis of primary hyperlipidemia; (2) In line with TCM qi stagnation and blood stasis syndrome; (3) The fasting LDL-C=4.14mmol/L, TC=6.22mmol/L, TG=2.26mmol/L, and the difference between two times should not exceed 12% ; (4) Lipid-lowering drugs or other lipid-lowering measures to disable at least 4 weeks; (5) Dietary evaluation of patients with hyperlipidemia = 5 points; (6) Aged 18 ~ 70 years male and female; (7) Those who volunteered and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Secondary dyslipidemia due to systemic diseases such as diabetic hypothyroidism, Cushing's syndrome, liver and kidney disease, systemic lupus erythematosus, myeloma, excessive alcohol consumption caused dyslipidemia; (2) Drug-induced secondary dyslipidemia: such as thiazide diuretics, ß-blockers, long-term heavy use of glucocorticoid and some contraceptives; (3) Heparin, thyroxine, and other drugs that affect blood lipid metabolism are being used, and anticoagulants are required for long-term clinical trials. (4) Familial hypercholesterolemia patients; (5) Those with acute coronary syndromes (such as myocardial infarction, unstable angina, etc.) or acute cerebrovascular accidents (such as stroke history) in the past 6 months and those with other serious cardiovascular diseases, or in the past 18 months had PCI and CABG and other major surgery; (6) Patients with unstable diabetic glycemic control, HbA1c> 7%, or diabetic complications (diabetic nephropathy, peripheral neuropathy) requiring medication control; (7) patients with severe liver and kidney dysfunction (ALT, AST> 1.5 times the upper limit of normal, Cr> upper limit of normal); (8) Hypertensive patients with poor drug control (blood pressure level after treatment: systolic blood pressure =160mmHg, diastolic blood pressure> 90mmHg) or hypotension (resting sitting blood pressure) <90 / 50mmHg; (9) Persons with mental illness, alcohol dependence or history of drug abuse; (10) Pregnant and lactating women and during their medication or within 3 months after the cessation of medication to prepare their children; (11) Allergy or previous allergy to many drugs, or allergic to the components of the study medication; (12) 3 months prior to the trial participated in other clinical studies; (13) Patients who other researchers think should not be involved in this study.

Design outcomes

Primary

MeasureTime frame
Low-density lipoprotein;

Secondary

MeasureTime frame
Total Cholesterol;Triglyceride;High-density lipoprotein;TCM Syndrome Score;Chinese medicine symptoms;The incidence of cardiovascular events;

Countries

China

Contacts

Public ContactGuoqing Ma

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

670344215@qq.com+86 15133196552

Outcome results

None listed

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