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Study on The Efficacy and Safety of Zhibitai Capsules in Patients with Type 2 Diabetes and Dyslipidemia

Study on The Efficacy and Safety of Zhibitai Capsules in Patients with Type 2 Diabetes and Dyslipidemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109105
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

type 2 diabetes and dyslipidemia

Interventions

Intervention Group:Zhibitai Capsules

Sponsors

Shuguang Hospital affiliated with Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients who meet the above-mentioned diagnostic criteria for type 2 diabetes as defined by Western medicine; 2. Age >= 18 years; 3. Lipid abnormalities should be diagnosed based on tests conducted within the last 4 weeks and meet at least one of the following conditions: (1) 1.8 mmol/L = 40 years old; (2) = 10 years; (3) Smoking; (4) Obesity (body mass index >= 28 kg/m^2 ); (5) Hypertension; fasting non-high-density lipoprotein cholesterol >= 4.9 mmol/L; (6) High-sensitivity C-reactive protein >= 2.0 mg/L; 5. For those with a history of lipid-lowering medication (traditional Chinese medicine or Western medicine), regroup for treatment after a washout period of 2 weeks.

Exclusion criteria

Exclusion criteria: 1. Known history of acute coronary syndrome (ACS), myocardial infarction (MI), stable or unstable angina, coronary or other revascularization, ischemic stroke, transient ischemic attack, and peripheral vascular disease (PAD); 2. Severe infection or concurrent serious medical illness, such as mental disorder, malignancy, congestive heart failure, or renal failure; 3. History of liver disease (excluding non-alcoholic fatty liver disease) or liver dysfunction, including unexplained persistent elevation of serum transaminases or abnormal baseline liver function tests (ALT or AST > 3×ULN); 4. CKD stage 4-5; 5. Other endocrine diseases that may affect lipid or lipoprotein levels, such as hypothyroidism; 6. Women who have attempted pregnancy in the past six months or are breastfeeding; 7. Currently participating in other clinical trials; 8. Allergic to the study drug components.

Design outcomes

Primary

MeasureTime frame
Low-density lipoprotein cholesterol, LDL-C;

Secondary

MeasureTime frame
Triglycerides, TG;HbA1c;Traditional Chinese Medicine Syndrome Scoring;glucose;

Countries

China

Contacts

Public ContactLu Hao

Shuguang Hospital affiliated with Shanghai University of TCM

luhao403@163.com+86 139 1671 9260

Outcome results

None listed

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