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The Clinical Study of Tangdifang Intervention on Spleen Deficiency and Phlegm Dampness Syndrome in Pre-diabetes and Its Mechanism of Targeting the Regulation of Intestinal Microflora BCAA

The Clinical Study of Tangdifang Intervention on Spleen Deficiency and Phlegm Dampness Syndrome in Pre-diabetes and Its Mechanism of Targeting the Regulation of Intestinal Microflora BCAA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000357
Enrollment
Unknown
Registered
2026-02-11
Start date
2024-05-30
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

Prediabetes

Interventions

Control Group:Provide health education and lifestyle intervention.
Experimental Group:Provide health education, lifestyle intervention, and sugar-regulating decoction.

Sponsors

Tsinghua University Yuquan Hospital (Tsinghua University Integrated Chinese and Western Medicine Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for TCM syndrome differentiation as well as the diagnostic criteria of Western medicine; 2. No use of antibiotics in the past 1 month; no history of probiotic supplementation; 3. No restriction on gender, age between 18-65 years old; 4. No history of severe liver or kidney dysfunction, diabetes, or related complications.

Exclusion criteria

Exclusion criteria: 1. Those with infections or injuries; 2. Patients with severe heart, liver, kidney, brain, hematopoietic, and metabolic disorders, as well as mental illnesses, who are unable to cooperate well; 3. Patients with pre-pregnancy needs, during pregnancy, or in the lactation period; 4. Patients who are unable to take medication on time or have difficulty adhering to the requirements to complete the trial; 5. Patients with drug allergies; 6. Patients who have participated in other clinical drug trials within the past 3 months or have a history of taking medications that may affect blood sugar levels.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine (TCM) Syndrome Efficacy;

Secondary

MeasureTime frame
Fasting Blood Glucose;2-hour postprandial blood glucose;Glycated albumin;glycated hemoglobin;Fasting serum insulin;BMI;Total Cholesterol, Triglycerides, Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL);

Countries

China

Contacts

Public Contactgaohuijuan

Tsinghua University Yuquan Hospital (Tsinghua University Integrated Chinese and Western Medicine Hospital)

gaohuijuanghj@126.com13001249259

Outcome results

None listed

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