A research for the clinical validity of Diabetes decoction which was set up by national medical master professor Yan Dexin and was used for treating type 2 diabetes with spleen-deficiency and blood-stasis syndrome in the early period

Phase 1

• Conditions: Type 2 diabetes

• Registration Number: ITMCTR1900002699
• Lead Sponsor: Shanghai Traditional Chinese Medicine Hospital

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. FBG< 13.8mmol/L, HbA1c< 9.0%, BMI> 23kg/m2, HOMA-IR> 2.8.
2. Aged 35-75 years.
3. Patients with newly diagnosed type 2 diabetes or whose course of disease is less than 3 years received sulfonylureas and guanidine blood glucose drugs for more than 3 months and the stable dose of sulfonylureas and guanidine drugs for at least 1 month were not allowed to use insulin therapy or other drugs that affect glucose and lipid metabolism during the test period
4. Spleen-deficiency and blood-stasis syndrome.
5. Signed informed consent and volunteered to participate in the study.

Exclusion Criteria

1. A history of severe heart disease.
2. There are serious chronic complications of diabetes.
3. Recent acute infectious disease and acute complications of diabetes.
4. Severe hypertension.
5. The researchers evaluated it is inappropriate for inclusion.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
FBG;FIns;TG;HOMA-IR;TC;PBG;HbAlc;