Study for the effect of traditional chinese medicine intervention on type 2 diabetes based on clinical pathway management

Phase 1

Recruiting

• Conditions: Type 2 diabetes

• Registration Number: ITMCTR1900002365
• Lead Sponsor: Guang'anmen 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) According to the 1999 WHO standard, meet the diagnostic criteria for type 2 diabetes;
(2) Aged 18 to 70 years;
(3) Sign the patient's informed consent form.
(4) Patients can provide detailed contact information, no short-term migration, and willing to cooperate with follow-up.
(5) Comply with the Drug TCM Clinical Pathway for Diabetes Mellitus, Traditional Chinese Medicine Diagnosis and Treatment Program for Diabetes Mellitus and Guidelines for Clinical Research of New Drugs in Traditional Chinese Medicine in 2010, the liver and stomach stagnation syndrome and yin deficiency fire certificate Diagnostic criteria for qi and yin deficiency syndrome and yin and yang deficiency syndrome.
(6) After screening period (dietary control exercise therapy for 2 weeks), FBG=7.0mmol/l, but <13.9mmol/l, or 2 hours after meal, blood glucose=11.1mmol/l.

Exclusion Criteria

(1) Diabetes complications have been diagnosed;
(2) Those with serious complications such as heart, lung, liver, kidney and brain, or those with other serious primary diseases;
(3) If the blood pressure is not controlled or controlled, the systolic blood pressure is >160 mmHg or the diastolic blood pressure is >100 mmHg;
(4) Patients with diabetic ketoacidosis or severe infection in the past 1 month;
(5) Women who are pregnant, breastfeeding, or ready to become pregnant;
(6) Those with impaired liver and kidney function (ALT, AST are more than 2 times the upper limit of normal value; serum creatinine is greater than the upper limit of normal value;
(7) Patients who are participating in other clinical trials;
(8) Psychiatric patients, alcohol and/or psychoactive substances, drug abusers and dependents;
(9) According to the judgment of the researcher, other lesions or situations 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;
(10) Those who are not fully aware of this study, are unwilling to participate, or have poor compliance; those who do not cooperate (can not cooperate with diet control, or do not follow the prescribed medication to affect the efficacy judgment).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin;

Secondary Outcome Measures

Name	Time	Method
BMI, waist circumference, hip circumference;Blood pressure;Four blood lipids;TCM symptom score;Subject anti-diabetic western medicine dose reduction rate;Blood sugar;Microvascular and macrovascular complications;Body weight;