Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Aged 18 to 70 years at the time of their consent;

2. Diagnosed with type 2 diabetes;

3. TG≥1.7 mmol/L or LDL-C≥3.4 mmol/L;

4. BMI≥24.0 kg/m2 or male waist circumference≥90 cm, female waist circumference≥80 cm;

5. Failed to reach the normal standards of blood glucose and lipids after diet control and exercise therapy before enrollment;

6. TCM Syndrome differentiation as excess heat in the stomach and intestines syndrome;

7. Signed informed consent.

Exclusion Criteria:

1. Type 1 diabetes, gestational diabetes, other special types of diabetes.

2. Diabetic complications were the main symptoms, that is, patients with serious heart, lung, liver, kidney, brain complications or other serious primary diseases.

3. Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month.

4. Have a history of serious gastrointestinal diseases, or are suffering from serious gastrointestinal diseases, such as peptic ulcer, gastrointestinal bleeding, gastroparesis, pyloric stenosis, gastric shunt, etc..

5. Psychiatric patients, alcoholism and/or psychoactive substances, drug abusers and addicts.

6. Pregnant, preparing for pregnancy or lactation.

7. Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies.

8. According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.