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Dendrobium Mixture on Mild Cognitive Impairment Associated with Type 2 Diabetes:Study protocol for a randomized controlled trial

Dendrobium Mixture on Mild Cognitive Impairment Associated with Type 2 Diabetes:Study protocol for a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000418
Enrollment
Unknown
Registered
2026-02-25
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Mild Cognitive Impairment Associated with Type 2 Diabetes

Interventions

the dendrobium mixture group :All patients will receive metformin or other hypoglycemic drugs. The treatment group will receive Dendrobium officinale mixture 200 ml/day, 100 ml/time, orally after meal
the placebo group:All patients will receive metformin or other hypoglycemic drugs, while the control group will take a simulated dendrobium mixture orally for a course of 12 weeks.

Sponsors

The Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Adults aged 50–75 years with T2DM (diagnosed per ADA criteria: HbA1c =6.5% or fasting blood glucose =126 mg/dL). (2) Mild cognitive impairment (Montreal Cognitive Assessment [MoCA] score 18-26). (3) Stable glycemic control (HbA1c 6.5–8.5%) for =3 months. (4) TCM syndrome differentiation of "yin deficiency with internal heat" or "qi-yin deficiency," consistent with dendrobium mixture's therapeutic profile.

Exclusion criteria

Exclusion criteria: (1)Severe diabetic complications (such as retinopathy, nephropathy, etc.). (2)Neurological disorders (such as stroke, Parkinson's disease, etc.). (3)Use of anti-dementia medications (such as donepezil, etc.) within 6 months.

Design outcomes

Primary

MeasureTime frame
MoCA;

Secondary

MeasureTime frame
HbA1c(%);Insulin resistance;lipid peroxide;serum superoxide dismutase;Blood glucose (fasting and two hours after meals);lipid profile;

Countries

China

Contacts

Public ContactHongbo Liu

The Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine

1923212882@qq.com+86 185 5870 9218

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026