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SHE Yao Hypoglycemic Formula for the Treatment of Diabetes Mellitus with Qi-Yin Deficiency Syndrome: A Randomized Controlled Trial

SHE Yao Hypoglycemic Formula for the Treatment of Diabetes Mellitus with Qi-Yin Deficiency Syndrome: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001419
Enrollment
Unknown
Registered
2026-06-05
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-22

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 + Zhe medicine glucose-lowering formula
Control Group:Basic treatment

Sponsors

Lishui Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old, without gender restriction. 2. Meets the diagnostic criteria for type 2 diabetes mellitus according to WHO (1999). 3. Meets the pattern identification criteria for qi and yin deficiency syndrome in traditional Chinese medicine.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes, specific types of diabetes, or gestational diabetes 2. Severe diabetes complications (creatinine = 1.5 times the upper limit of normal, history of myocardial infarction or stroke) 3. Occurrence of diabetic ketoacidosis or severe hypoglycemic events in the past 3 months 4. Abnormal liver function (ALT or AST = 2.5 times the upper limit of normal) 5. Allergy to components of the investigational drug 6. Participation in other clinical trials within the past 3 months

Design outcomes

Primary

MeasureTime frame
glycated hemoglobin;

Secondary

MeasureTime frame
Fasting Blood Glucose;Postprandial 2-hour blood glucose;creatinine;Urea nitrogen;Glomerular filtration rate;Serum Cystatin C;Serum uric acid;Urine ß2 microglobulin;Urine a1microglobulin;Urinary microalbumin;Urinary Albumin-Creatinine Ratio;Alanine Aminotransferase;Glutamic-oxaloacetic transaminase;Alkaline phosphatase;Gamma-glutamyl transferase;Total Bilirubin;Direct Bilirubin;Unconjugated bilirubin;Serum albumin;Total Protein;Total Cholesterol;Triglyceride;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Body fat percentage;Visceral Fat Area;Weight;Body Mass Index;

Countries

China

Contacts

Public ContactSun Xia

Lishui Hospital of TCM

403343150@qq.com13757099161

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026