FindTrial
Sign In

Evidence-based capacity building project of traditional Chinese medicine for prevention and treatment of type 2 diabetes --A multi-center randomized controlled clinical study on the treatment of newly diagnosed type 2 diabetes mellitus with damp-heat syndrome by Huashi Jiangzhuo recipe

Evidence-based capacity building project of traditional Chinese medicine for prevention and treatment of type 2 diabetes --A multi-center randomized controlled clinical study on the treatment of newly diagnosed type 2 diabetes mellitus with damp-heat syndrome by Huashi Jiangzhuo recipe

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006156
Enrollment
Unknown
Registered
2022-06-16
Start date
2022-06-05
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

type 2 diabetes mellitus

Interventions

test team:Huashi Jiangzhuo prescription + dapagliflozin
control group:placebo + dapagliflozin

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 ) The initial diagnosis conformed to the diagnostic criteria of T2DM, or the diagnosis was that T2DM was not more than one year, and no hypoglycemic drugs were used, FBG < 11.1 mmol / L, 7.5 % < glycated hemoglobin < 9.5 %, BMI = 24 kg / m2, glomerular filtration rate ( eGFR ) = 60 ml / min / 1.73 m2 ; 2 ) in line with TCM damp-heat syndrome type ; 3 ) Ages above 18 and below 70, regardless of race or gender ; 4 ) Sign informed consent to participate voluntarily in the experiment.

Exclusion criteria

Exclusion criteria: 1 ) pregnant women or women with pregnancy plans, lactating women ; 2 ) Patients with net contraindications to daglitazone ; 3 ) Patients allergic to TCM components ; 4 ) Patients with severe heart, liver, kidney, brain, blood system and other complications or other severe primary diseases and mental patients ; 5 ) Patients who had participated in other drug clinical trials or were participating in other clinical trials within three months before participating in this trial ; 6 ) Patients with diabetic ketosis, ketoacidosis and severe infection within one month ; 7 ) Urinary system infection, reproductive system infection ;

Design outcomes

Primary

MeasureTime frame
2h postprandial blood glucose;fasting blood glucose;glycosylated hemoglobin;—

Secondary

MeasureTime frame
uric acid;24-hour urine sugar;retinol-binding protein;fasting insulin level;blood fat;bilirubin;24-hour urine sugar;urinary ?1 microglobulin;urine albumin creatinine ratio;traditional chinese medicine symptom score;beta 2-microglobulin;SF-36 Quality of Life Scale;—

Countries

China

Contacts

Public ContactWei Junping

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

weijunping@126.com13661067768

Outcome results

None listed

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