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The effect of modification of Chai Shao Liu Jun Zi Tang on islet sensitivity in patients with Type 2 diabetes mellitus and Liver Qi stagnation and Spleen deficiency syndrome.

The effect of modification of Chai Shao Liu Jun Zi Tang on islet sensitivity in patients with Type 2 diabetes mellitus and Liver Qi stagnation and Spleen deficiency syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000737
Enrollment
Unknown
Registered
2026-03-25
Start date
2023-01-10
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Diabetes

Interventions

Research Group:Administer Chai Shao Liu Jun Zi Tang with modification as adjunct therapy to the standard hypoglycemic regimen.
Basic Group:Administer metformin as part of the standard hypoglycemic treatment regimen.

Sponsors

Nanyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)Refer to the diagnostic criteria for T2DM published by the Diabetes Society of the Chinese Medical Association (CDS) in 2020; 2) Age between 18 and 75 years old; 3) Refer to the diagnostic criteria for Liver Qi Stagnation and Spleen Deficiency syndrome in the "Guidelines for Integrated Traditional and Western Medicine Treatment of T2DM": pale red tongue with white or greasy coating, taut and thin or slippery pulse; main symptoms include (costal pain), irritability, and abdominal distension; secondary symptoms include fatigue, poor appetite, constipation or diarrhea, and insomnia; 4) Fasting blood glucose (FBG) = 11.1 mmol/L, hemoglobin A1c (HbA1c) between 7% and 10%; 5) Voluntary participation and informed consent.

Exclusion criteria

Exclusion criteria: Type 1 diabetes, gestational diabetes, or other specific types of diabetes; 2) Severe cardiovascular diseases, liver and kidney dysfunction, neurological disorders, and malignant tumors; 3) Use of other traditional Chinese medicine formulations within the past month; 4) History of alcohol or substance abuse; 5) Allergic constitution; 6) Occurrence of acute diabetic complications within the past month; 7) Pregnant or breastfeeding patients.

Design outcomes

Primary

MeasureTime frame
Continuous Glucose Monitoring Indices;

Secondary

MeasureTime frame
Islet sensitivity index;Lipid factor;

Countries

China

Contacts

Public ContactLi Zengyi

Nanyang Central Hospital

lizengyi7777@163.com15993194020

Outcome results

None listed

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