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Multi-center randomized double-blind controlled trial for Tangzhifang in the treatment of pre-diabetes

Standardized training of Chinese medicine for prevention and treatment of diabetes and development of Tangzhifang

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019413
Enrollment
Unknown
Registered
2018-11-10
Start date
2018-12-01
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

Pre-diabetes

Interventions

Group 1:Tangzhifang
Group 2:Placebo

Sponsors

Gansu Provincial Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form; 2. in line with the pre-diabetes diagnostic criteria, and syndrome differentiation for the spleen and stomach stagnation syndrome patients; 3. aged 18-70 years old.

Exclusion criteria

Exclusion criteria: 1. Those who have used hypoglycemic drugs and insulin therapy in the past; 2. Cardiovascular events (cerebral vascular accidents in the past 6 months, myocardial infarction or heart failure; those with severe organic heart disease; those with aortic aneurysm or dissection aneurysm; specific angina, type II Ventricular conduction block, sick sinus syndrome); 3. Impaired liver and kidney function: AST and / or ALT is equal to or greater than 2 times the upper limit of normal; creatinine is equal to or greater than the upper limit of normal. Urine protein > ++ and / or hematuria; 4. People with endocrine diseases (such as hyperthyroidism), autoimmune diseases, cancer or other serious fatal diseases; 5. Those who have used glucocorticoids, beta blockers, thiazide diuretics and niacin; 6. Pregnancy, pregnancy or lactation women; 7. Psychiatric patients or non-cooperative patients; 8. Patients who have participated in other drug clinical trials or are participating in other clinical trials within one month prior to the trial; 9. Those who are known to be allergic to traditional Chinese medicine ingredients; 10. After blood pressure is uncontrolled or controlled, SBP>160mmHg, DBP>100mmHg and those with secondary hypertension; 11. Alcohol and/or psychoactive substances, drug abusers and dependents in the past 5 years; 12. According to the judgment of the investigator, other lesions or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment and unstable living environment, may cause loss of follow-up; 13. It is known that there is no feeling for hypoglycemia.

Design outcomes

Primary

MeasureTime frame
Type 2 diabetes incidence;

Secondary

MeasureTime frame
HbA1c;Islet function;Glucose tolerance test;Syndrome points;

Countries

China

Contacts

Public ContactQiu Lianli

Gansu Provincial Hospital of TCM

1172557741@qq.com+86 13919442943

Outcome results

None listed

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