Astragalus root extract combined with metformin to correct metabolic status of patients with pre-diabetes (or poor blood sugar control in type 2 diabetes mellitus): a randomized controlled study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073747

Enrollment

Unknown

Registered

2023-07-20

Start date

2023-07-20

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

pre-diabetes (or type 2 diabetes)

Interventions

group MET:melbine (2000mg/d) + health education

group MET+APS:melbine (2000mg/d) + astragalus root extract (take one capsule once, 3 days with meals) + health education

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Fasting blood glucose is high in pre-diabetes: the fasting blood glucose level is 6.1-6.9mmol/L or the efficacy of metformin in type 2 diabetes is poor: newly diagnosed as type 2 diabetes, HbA1c=7.0% and 17%) 2. No microecological agents or antibiotics were used for 4 weeks before joining the group. 3. Age range between 18 and 60 years old.

Exclusion criteria

Exclusion criteria: 1. Patients with severe gastrointestinal reaction who can't tolerate metformin (or newly diagnosed with type 2 diabetes, HbA1c=7.0% and 300 mg/g 17. Triglyceride value exceeds 5.6 mmol/L; 18. Active liver disease and/or obvious abnormal liver function, which is defined as alanine aminotransferase (ALT) > 2.5 times the upper limit of normal value and/or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal value and/or total bilirubin > 1.5 times the upper limit of normal value; 19. ECG examination has clinically significant arrhythmia and needs treatment or intervention, and some researchers judge that it is not suitable to participate in this clinical trial; 20 human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive; Hepatitis B surface antigen is positive and the quantitative detection value of HBVDNA is higher than the upper limit; Hepatitis C antibody is positive and HCVRNA quantitative detection value is hig

Design outcomes

Primary

Measure	Time frame
Fasting insulin ;Fasting C-peptide;fasting blood glucose(FBG); 2-hour postprandial blood glucose(OGTT 2h);glycated albumin (GA);HbA1c;Time in Range (TIR);IL-1ß;IL-6;IL-18;hs-CRP or CRP;TNF-a;MCP-1;IL-10;TG;TC;LDL-C;HDL-C;Metabolites in the blood;Fecal microflora;Metabolites of fecal flora;	—

Secondary

Measure	Time frame
weight;waist circumference or body composition;blood pressure;	—

Countries

China

Contacts

Public ContactDan Yan

Beijing Friendship Hospital ,Capital Medical University

pharmsci@126.com+86 134 8867 8873

Outcome results

None listed

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