Evaluation of clinical efficacy and mechanism of Yunv Decoction in treating type 2 diabetes mellitus with syndrome of yin deficiency due to intense heat

Not Applicable

• Conditions: diabetes mellitus

• Registration Number: ITMCTR2200005821
• Lead Sponsor: Guang'anmen Hospital of 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) Newly diagnosed patients who meet the diagnostic criteria of T2DM with T2DM and Yin deficiency syndrome, and who have not received drug treatment before or who have only received first-line hypoglycemic drug (metformin hydrochloride) treatment;
(2) Glycated hemoglobin=7.0%, FBG<13.9mmol/L;
(3) Age 30-65 years old, regardless of race and gender;
(4) Body mass index (BMI)>18.0 kg/m2;
(5) Sign the informed consent form and voluntarily participate in this experiment.
Included patients must meet all the above conditions, any one is No, this subject cannot participate in the trial.

Exclusion Criteria

(1) Acute diabetic complications, including diabetic ketosis, diabetic ketoacidosis, and serious infections;
(2) Severe chronic diabetes complications;
(3) Serum alanine aminotransferase, aspartate aminotransferase > 3 times the upper limit of normal, abnormal serum creatinine or serum urea nitrogen;
(4) Patients with severe heart, liver, kidney, brain, blood system and other complications or combined with other serious primary diseases;
(5) Have serious mental health conditions or other uncontrollable systemic diseases;
(6) Patients currently or one month ago receiving another experimental drug;
(7) Known or suspected allergy to the study drug;
(8) Women who are pregnant or planning to become pregnant, and lactating women;
(9) Continuous use of antibiotics in the past 3 months, and the course of treatment exceeds 3 days;
(10) The patient has taken probiotics/prebiotics or other microecological regulators in the past 3 months.
If any of the above is yes, the subject cannot participate in the trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
2hPG;FPG;HbAlc;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome score;Fasting insulin level and C-peptide detection;blood lipids;