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Comparative study on the clinical efficacy and safety of different doses of Jiedu Tongluo Tiaogan formula granules in the treatment of type 2 diabetes mellitus

Comparative study on the clinical efficacy and safety of different doses of Jiedu Tongluo Tiaogan formula granules in the treatment of type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086863
Enrollment
Unknown
Registered
2024-07-12
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

type 2 diabetic mellitus

Interventions

Control group:Metformin tablets + Jiedu Tongluo Tiaogan formula placebo
Low-dose group of Chinese medicine granules:Metformin tablets + Jiedu Tongluo Tiaogan formula granules (0.6 times the group of traditional Chinese medicine tablets)
Medium Dose Group of Chinese Medicine Granules:Metformin tablets + Jiedu Tongluo Tiaogan formula granules (0.8 times the group of traditional Chinese medicine tablets)
High Dose Group of Chinese Medicine Granules:Metformin tablets + Jiedu Tongluo Tiaogan formula granules (1 times the group of traditional Chinese medicine tablets)
Chinese Medicine tablets prepared in granule form:Metformin tablets + Jiedu Tongluo Tiaogan formula tablets prepared in granule form

Sponsors

Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria of T2DM in western medicine; ? Patients who meet the diagnosis of liver-stomach depression and heat syndrome. ? Age 18-75 years old; ? Blood glucose control is relatively stable, with fasting blood glucose 18 and <28 kg/m^2; ? Those who have full independent behavioral ability and sign the informed consent form and agree to participate in this study.

Exclusion criteria

Exclusion criteria: ?People with comorbid mental illness or cognitive dysfunction; ? the presence of tumors, severe liver and kidney insufficiency, acute and chronic infections and other medical conditions; ?Patients in special periods such as pregnancy and lactation; ? Those who have experienced critical illness or serious complications such as diabetic ketoacidosis within the last 2 months; ? Patients who are participating in other clinical trials; ?Alcohol and/or psychoactive substances abuse, drug abusers and dependents; ?Other lesions or conditions that, in the judgment of the investigator, have the effect of reducing the likelihood of enrollment or complicating enrollment, such as frequent changes in the work environment, unstable living conditions, and other conditions that predispose to loss of visits; (8) Those who are allergic to the test drug.

Design outcomes

Primary

MeasureTime frame
TCM syndrome score;

Secondary

MeasureTime frame
glycosylated hemoglobin;fasting blood sugar;2h postprandial blood glucose;serum lipids;

Countries

China

Contacts

Public ContactChunli Piao

Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine

pcl2013@sina.cn+86 188 1907 5590

Outcome results

None listed

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