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Clinical study for treating overweight and obesity T2DM patients using Chinese herbal JPQW recipe

A randomized, parallel controlled clinical study for comparing Chinese herbal JPQW recipe combined with metformin versus metformin monotherapy in treating overweight and obesity T2DM patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022013
Enrollment
Unknown
Registered
2019-03-20
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Type 2 Diabete

Interventions

Control group:Metformin
JPQW Group:Chinese medicine JPQW Recipe

Sponsors

Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Comply with the diagnostic criteria of type 2 diabetes, the duration of diabetes is = 5 years; (2) Patients diagnosed with pleen deficiency and stomach heat syndrome according to syndrome differentiation of TCM; (3) Aged 18-70 years, no gender limitation; (4) Fasting blood glucose (FBG) < 13.9mmol/L; (5) Glycated hemoglobin (HbA1c) = 11.0%; (6) 24.0 kg/m2 = body mass index (BMI) = 35kg/m2; (7) Blood pressure = 180/100 mmHg; (8) Written informed consents will be obtained before enroll, volunteering to participate in study.

Exclusion criteria

Exclusion criteria: (1) Patinets who suffered diabetic critical illness in the past 4 weeks, such as ketoacidosis, hyperosmotic state of diabetes; (2) Patients diagnosed with major vascular complications, such as myocardial infarction, cerebrovascular infarction, lower extremity vascular disease; (3) Patiens with severe heart and lung disease, renal insufficiency, hematopathy, cancers or other serious diseases that affect its survival; (4) Infectious diseases such as acute gastroenteritis or those who have taken antibiotics and intestinal flora regulators in the past 2 weeks; (5) Those has been diagnosed with chronic atrophic gastritis, chronic enteritis, gastroduodenal ulcer and other intestinal diseases or patients receiving medication; (6) Pregnancy, Lactating women; (7) Patients who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
fasting blood glucose;glycated hemoglobin a1c;blood lipid profile;fasting serum insulin;DNA of stool flora;

Countries

China

Contacts

Public ContactXie Shaofeng

Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine

xiesf3562@sina.com+86 025 85608733

Outcome results

None listed

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