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A randomized, double-blind, placebo-controlled clinical trial of berberine in the treatment of primary dyslipidemia

A randomized, double-blind, placebo-controlled clinical trial of berberine in the treatment of primary dyslipidemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021361
Enrollment
Unknown
Registered
2019-02-17
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-02-18

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

Conditions

Dyslipidemia

Interventions

Experimental group:hydrochloric acid small split alkali tablets, oral, 500mg/ time, 2 times/day, morning and evening meal half an hour to take, course of treatment: 12 weeks
Control group: hydrochloric acid small split alkali tablet placebo, oral, 500mg/ time, 2 times/day, morning and evening meal half an hour to take, course of treatment: 12 weeks

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with primary dyslipidemia; 2. LDL-C=4.1 mmol/L and TG=2.3 mmol/L (equivalent to WHO typing IIb); 3. Age 18-65 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. Those with severe or active liver disease; 6. 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; 7. Allergic persons; 8. Known to be berberine intolerance; 9. Other diseases or psychosis that the investigator believes may limit efficacy evaluation or patient follow-up; 10. Patients who have participated in other drug clinical trials in the past 4 weeks.

Design outcomes

Primary

MeasureTime frame
LDL-C;

Secondary

MeasureTime frame
TG;TC;HLD-C;hs-CRP;Blood pressure;weight;Bristol Stool Chart;traditional Chinese medicine symptom;

Countries

China

Contacts

Public ContactWu Shengxian

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

wushx@sina.com+86 010 84015528

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026