Efficacy and safety of Zhenyuan capsule in improving the glucose metabolism of pre-diabetes patients: a randomized controlled trial

Phase 4

• Conditions: Pre-diabetes

• Registration Number: ITMCTR2000003411
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Fasting venous blood glucose >=6.1 and < 7.0 mmol/L and / or 2 hours after meal venous blood glucose >=7.8 and <11.1 mmol/L;
2. Patients aged 18-65 years;
3. Patients with informed and voluntary consent.

Exclusion Criteria

1. The patients with type 2 diabetes were previously diagnosed;
2. Patients who have participated in other clinical trials or received hypoglycemic drugs in the past 3 months;
3. Patients with cardiovascular and cerebrovascular adverse events in the past 6 months;
4. Patients with severe trauma, major infectious diseases, major organ functions or organic diseases and psychosis;
5. Patients who are allergic to known components of the test drug;
6. Women in pregnancy and lactation.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosed as diabetes;

Secondary Outcome Measures

Name	Time	Method
Acute and chronic complications of diabetes;All-cause mortality;Hospitalized due to acute cardiovascular and cerebrovascular events;