Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT01844050
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
* After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l\<2h PG\<16mmol/l
* Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
* Subject is willing to participate and capable of giving informed consent.
Exclusion Criteria:
* Those patients used any drugs for treatment of diabetes within one month.
* Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
* Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
* Women who were pregnant, lactating or planned pregnant.
* Allergic constitution and has a history of drug allergy.
* Combined with severe acute or chronic infections.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01844050
Study Brief:
Protocol Section:
NCT01844050