Skip to content

A multicenter clinical study for Xiaoke formula based on PTP1B inhibition in the treatment of refractory type 2 diabetes mellitus

A multicenter clinical study for Xiaoke formula based on PTP1B inhibition in the treatment of refractory type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026815
Enrollment
Unknown
Registered
2019-10-23
Start date
2019-11-30
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Type 2 Diabetes

Interventions

Sponsors

Yueyang Hospital of integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years male and female; 2. type 2 diabetes patients who meet the diagnostic criteria of Western medicine for diabetes; those who meet the syndrome of deficiency of both qi and Yin in traditional Chinese medicine; 3. those who use insulin (> 0.6 IU/kg) and metformin as the basic treatment, combined with one or two other hypoglycemic drugs, and the dosage is stable, no less than 4 weeks; 4. those who have poor blood glucose control: Blood FPG 7.5 to 10.0 mmol/l; HbA1c 7 to 10.0% (subject to the test value of each center); 5. the subject is informed and signs the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Gestational diabetes mellitus, type 1 diabetes mellitus and other special types of diabetes mellitus; 2. patients with acute complications of diabetes mellitus; 3. patients with serious cardiovascular and cerebrovascular diseases and serious primary diseases such as liver, kidney and hematopoietic system; 4. those who are allergic to the known ingredients of the study drug and whose constitution is allergic; 5. pregnant and lactating women and those who have recently had fertility plans; 6. those who have long-term alcohol, drug dependence and mental illness Patients with disease; 7. patients treated with traditional Chinese medicine or proprietary Chinese medicine with oral hypoglycemic purpose within one month before screening; 8. those who participated in or are participating in clinical trials of other drugs within one month before the screening period of this study; 9. researchers think that they are not suitable to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
blood glucose;glycosylated hemoglobin;C peptide;

Secondary

MeasureTime frame
routine blood test;Urine routine;liver function;renal function;

Countries

China

Contacts

Public ContactHongjie Yang

Yueyang Hospital of integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

yanghongjie1964@aliyun.com+86 18930560891

Outcome results

None listed

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