Randomized controlled clinical trial of Dan Zhi Jiang Tang Capsule in treating type 2 diabetes mellitus with Qi Yin deficiency and blood stasis syndrome

Phase 1

• Conditions: type 2 diabetes mellitus

• Registration Number: ITMCTR2100005146
• Lead Sponsor: the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

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. Aged 18 to 75 years (including both ends), gender is not limited;
2. Patients with type 2 diabetes who meet the diagnostic criteria of Western medicine for diabetes;
3. Those who conform to the syndrome of qi and yin deficiency in traditional Chinese medicine with blood stasis;
4. Those who only received metformin hydrochloride tablets, and 0.5g/time, 3 times/day, not less than 2 weeks;
5. Poor control: blood sugar [6.5mmol/L<=FPG (venous blood)=10.0mmol/L; 7.0%6. Patients were informed and signed the informed consent voluntarily.

Exclusion Criteria

1. Patients with type 2 diabetes who need insulin therapy;
2. Patients with acute complications of diabetes;
3. Combined with severe 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 research drug and have allergic constitution;
5. Pregnant, lactating patients and those who have a childbearing plan in the near future;
6. Long-term alcoholism, drug dependence, mental illness patients;
7. Patients who have taken oral Chinese medicine or Chinese patent medicine for hypoglycemic purpose within 1 month before screening;
8. Those who have participated in or are participating in other drug clinical trials within one month before the screening period of this study;
9. The researcher believes that it is not suitable to participate in this clinical study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
2h postprandial venous blood glucose;Fasting blood glucose;