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Based on the theory of Sanjiao Qi-hua and mitochondrial energy metabolism, to investigate the mechanism of Compound Sang Bai Pi Formula in treating T2DM.

Based on the theory of Sanjiao Qi-hua and mitochondrial energy metabolism, to investigate the mechanism of Compound Sang Bai Pi Formula in treating T2DM.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000781
Enrollment
Unknown
Registered
2026-03-27
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Type 2 Diabetes

Interventions

Treatment group:Basic treatment combined with Compound Sang Bai Pi Formula
Control Group:Basic treatment plus Compound Sang Bai Pi Formulaplacebo.

Sponsors

Xiyuan Hospital of CACMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 45–75 years, gender; (2) Meet the diagnostic criteria for Type 2 Diabetes Mellitus and the criteria for of spleen deficiency with damp-heat; (3) 7% = HbA1c = 10%; (4) Using oral hypoglycemic agents or insulin as the, with stableand, used for at least 4 weeks, and blood glucose still poorly controlled after intervention; (5) T2DM disease history = 10 years; (6) Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Acute complications of diabetes occurred within 1 month; (2) Patients with malignant tumors, those undergoing hormone therapy, or those with other endocrine diseases affecting blood sugar; (3) Patients previously diagnosed with severe arrhythmias, severe liver or kidney dysfunction, or severe organic lesions in the liver, kidneys, or other organs, as well as those with thyroid dysfunction; (4) Pregnant or breastfeeding women; (5) Individuals with intellectual disabilities, impaired consciousness, mental illness, or severe aphasia who are unable to cooperate; (6) Patients allergic to or intolerant of traditional Chinese medicine; (7) Individuals with plans to conceive within the next six months; (8) Participants in other clinical studies at the same time.

Design outcomes

Primary

MeasureTime frame
Glycemic Control Rate;

Secondary

MeasureTime frame
Glycemic Metabolism Indicators;Insulin resistance and ß-cell function indicators;

Countries

China

Contacts

Public ContactLiu Zhengtang

Xiyuan Hospital of CACMS

doctorzht@126.com13951616817

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026