Skip to content

Efficacy and safety of berberine for Low high-density lipoprotein cholesterol: study protocol for a randomized double-blind placebo- controlled trial

Efficacy and safety of berberine for Low high-density lipoprotein cholesterol: study protocol for a randomized double-blind placebo- controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005633
Enrollment
Unknown
Registered
2022-02-10
Start date
2022-02-14
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Low high-density lipoprotein cholesterol

Interventions

treatment group:Berberine(500mg twice daily)will be administrated orally for 12 weeks.
control group:Placebo(500mg twice daily)will be administrated orally for 12 weeks.

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with primary dyslipidemia; 2. HDL-C=1.0mmol/L; 3. Age 18-70 years old; male or female; 4. Those who have not taken lipid-lowering drugs in the past 1 month; 5. Can adhere to long-term medication; 6. The patient's informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Recent (within 4 weeks) myocardial infarction, or stenting, or bypass surgery, or stroke; 2.Diabetes, nephrotic syndrome and renal insufficiency; 3.Those with poor hypothyroidism or other endocrine diseases; 4.Those whose liver function is more than 2 times the upper limit of normal value; 5.TG=11.3mmol/L 6.Those with severe or active liver disease; 7. Any other life-threatening or serious illness that cannot be completed for 12 weeks of treatment so as to affect the results of the evaluation; 8.Allergic persons; 9.Pregnant person or planning to become pregnant; 10.Known to be berberine intolerance; 11.Other diseases or psychosis that the investigator believes may limit efficacy evaluation or patient follow-up; 12.Patients who have participated in other drug clinical trials in the past 4 weeks.

Design outcomes

Primary

MeasureTime frame
HDL-C;

Secondary

MeasureTime frame
HDL2-C;TG;Blood pressure;TC;LDL-C;weight;HDL-C subclasses(HDL3-C);traditional Chinese medicine symptom;

Countries

China

Contacts

Public ContactYa-Wei Du
yaweidu@hotmail.com01084013663

Outcome results

None listed

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