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Effects of Astragalus membranaceus on Glycemic Control and Gut Microbiota in Patients with Qi Deficiency Type of Newly Diagnosed Type 2 Diabetes Mellitus

Effects of Astragalus membranaceus on Glycemic Control and Gut Microbiota in Patients with Qi Deficiency Type of Newly Diagnosed Type 2 Diabetes Mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000047
Enrollment
Unknown
Registered
2026-01-10
Start date
2022-08-08
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Diabetes

Interventions

Experimental Group:Astragalus granules + insulin
Control Group:Placebo + Insulin

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Putuo Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18-80 years, gender; (2) All are newly diagnosed with diabetes and have not used any oral hypoglycemic drugs or combined treatment regimens (including compound formulations) or insulin before enrollment; (3) Patients with type 2 diabetes, with HbA1c ranging from 9% to 11%; (4) Syndrome differentiation belongs to qi deficiency type; (5) Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) T1DM, gestational diabetes, and other specific types of diabetes; (2) History of acute diabetic complications (including diabetic hypoglycemia, diabetic hyperosmolar coma, etc.); (3) Significant impairment of heart, liver, or kidney functions; (4) Use of antibiotics, probiotics, or microecological live bacterial preparations within the past 1 month; (5) Have experienced =1 severe hypoglycemic episode in the past 6 months or recurrent hypoglycemic events in the past 1 month; (6) History of gastrointestinal surgery or irritable bowel syndrome; (7) Patients with mental illness; (8) Individuals with a history of allergies; (9) Anticipated significant lifestyle changes (e.g., working night shifts) or major dietary changes during the study period.

Design outcomes

Primary

MeasureTime frame
glucagon-like PePtide-1;gut microbiota;

Secondary

MeasureTime frame
Gender;Age;disease course;Weight;Fasting Plasma glucose;Two-hour PostPrandial blood-glucose;Glycosylated hemoglobin;Fasting insulin;Fasting C-PePtide ;Traditional Chinese Medicine Syndrome Scoring;

Countries

China

Contacts

Public ContactHou Keke, Chen Lin

Shanghai University of Traditional Chinese Medicine Affiliated Putuo Hospital

kkkl42523@126.com18838051489

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026