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

Launched by GUANG'ANMEN HOSPITAL OF CHINA ACADEMY OF CHINESE MEDICAL SCIENCES · Nov 5, 2020

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ClinConnect Summary

This clinical trial is studying the effectiveness of a Chinese herbal medicine called Jiangtang Tiaozhi Recipe in treating people with type 2 diabetes and high levels of fats in the blood, known as dyslipidemia. The researchers will recruit 96 participants who are between 18 and 70 years old and have been diagnosed with type 2 diabetes but have not been able to control their blood sugar and fat levels through diet and exercise alone. Participants will be divided into two groups: one will receive the herbal treatment, while the other will take a common diabetes medication called metformin.

Over a period of 12 weeks, the researchers will monitor how well the treatments work by measuring changes in blood sugar levels, fat levels in the blood, and other health indicators like body weight and waist size. To be eligible for this trial, participants must meet certain criteria, such as having a body mass index (BMI) of at least 24 or specific waist measurements. This study is currently recruiting participants, and it’s important for anyone interested to speak with their healthcare provider to see if they qualify and to understand what participation entails.

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Eligibility 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.