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Efficacy and safety of the Sancailianmei Particle in patients with type 2 diabetes and nonalcoholic fatty liver disease: an open-label, randomised controlled trial

Efficacy and safety of the Sancailianmei Particle in patients with type 2 diabetes and nonalcoholic fatty liver disease: an open-label, randomised controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033099
Enrollment
Unknown
Registered
2020-05-20
Start date
2020-05-16
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Type 2 diabetes combined with nonalcoholic fatty liver disease

Interventions

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients with type 2 diabetes mellitus and nonalcoholic fatty liver who meet the criteria of diabetes diagnosis and classification; 2. Patients aged 18-75 years; 3. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with type 1 diabetes; patients with latent autoimmune diabetes, malignant tumor or other autoimmune diseases in adults; 2. In type 2 diabetic patients, fasting blood glucose was more than 11.1mmol/l; 3. Patients who used insulin continuously for more than 2 weeks in the past 3 months, or need insulin treatment at present; 4. Patients who have been taking other drugs for reducing blood sugar and regulating blood fat that have influence on liver within 3 months or are currently taking orally; 5. Patients taking GLP-1 antidiabetic drugs within 3 months or at present; 6. Acute and chronic complications of diabetes, including diabetic ketoacidosis, diabetic hyperosmotic nonketotic coma, hypoglycemic coma or severe unconscious hypoglycemia; 7. Patients with severe gastrointestinal diseases, such as intestinal obstruction, intestinal ulcer or obvious digestive and absorption dysfunction; 8. Patients with heart failure, unstable angina, serious arrhythmia, and myocardial infarction in the past 12 months; those with SBP > 180mmhg or DBP > 100mmhg; 9. Patients with history of active liver disease (excluding nonalcoholic fatty liver), including chronic active hepatitis B or C (assessed by history), primary biliary cirrhosis or symptomatic gallbladder disease, hepatolenticular degeneration, drug-induced liver disease, etc.; child Pugh grade C of liver function; 10. Patients with renal disease or clinical history of renal insufficiency, whose serum creatinine is more than 1.5mg/dl (132.6 µ mol / L); 11. Patients with other endocrine system diseases, such as hyperthyroidism and cortisol; 12. Patients who are suffering from serious trauma, serious infection or undergoing surgery, as well as those who are treated but not fully recovered; 13. Objects with mental illness, drug or other substance abuse or alcohol abuse; 14. Patients undergoing steroid hormone therapy or cancer therapy; 15. Patients with allergic constitution or allergic to drugs used in this study; 16. Pregnant and lactating women, women of childbearing age who did not take effective contraceptive measures, or those who planned to be pregnant during the trial, and those whose urine HCG test results were positive; 17. Participants in other drug trials within 3 months; 18. Patients whose families do not agree to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Fibroscan Index;MIR-PDFF Index;body fat indexes;AGEs;P?P;

Countries

China

Contacts

Public ContactShengju Wang

Affiliated Hospital of Chengdu University of traditional Chinese medicine / Sichuan Hospital of traditional Chinese Medicine

anshu1016@126.com+86 18798866548

Outcome results

None listed

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