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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT01219803
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes mellitus
* 30-65 years old
* HbA1c≥7.0%, and FPG\>7.0 mmol/L, but \<13.9 mmol/L or 2hPG\>11.1 mmol/L
* Informed consent has been signed
* Dampness and Heat in Spleen
Exclusion Criteria:
* The patients accepted diabetic treatment for more than a month continuously
* The patients were treated by drugs in 3 week before they were given test drugs
* Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month
* The contractive pressure \>160 mmHg or diastolic pressure \>100 mmHg
* Pregnant, preparing for pregnancy or breast-feeding women
* Mental patients
* The patients whose ALT or AST are \>100U/L,and BUN or Cr are abnormal.
* The patients who have serious heart, lung, liver, kidney and brain or other primary complications
* Allergic persons
* The patients who are attending other clinical trial
* The patients who have serious diabetic complications
* The patients who ever attended this clinical trial
* Alcohol and / or psychoactive substances, drug abuse and dependency
* The person maybe loss for some reason such as work or life condition according to the investigator's judgement
* The lipid-lowering or antihypertensive drug dosage and category which the patients are taking could not be kept stable
* The patients who are eating some drugs or health food which can affect the body weight
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01219803
Study Brief:
Protocol Section:
NCT01219803