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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT02617732
Eligibility Criteria:
Inclusion Criteria
* 18.5kg/m2≤BMI≤35.0 kg/m2;
* meet type 2 diabetes mellitus diagnostic criteria published by 1999 WHO;
* with blood variability, defined as standard deviation of blood glucose more than 3.5mmol／L within 2 days by self-monitoring of blood glucose（SMBG）(more than 5 times per day)
* diabetic duration more than 1 year; in stable condition for more than 4 weeks with unchanged lifestyle and other drugs intervention; （permit taking metformin or sulphonylureas which dosage is unchanged during study period ）
* HbA1c≤10％;
* signed the informed consent form.
Exclusion Criteria:
* have acute diabetes complications （e.g. diabetic ketoacidosis，diabetic hyperosmolar coma,diabetic lactic acidosis,Hypoglycemic coma）
* have severe chronic diabetes complications(e.g. diabetic retinopathy stage 4\~6,severe diabetic nephropathy needs dialysis and so on）
* have gastrointestinal disease which have serious influence on digestive function and disorder of absorption
* have other endocrine disease (hyperthyroidism,acromegaly,Cushing's syndrome and so on.)
* have severe heart disease(such as acute myocardium infarction, unstable angina,heart failure NYHA functional classification III or IV）
* have moderate or severe liver function abnormality(ALT,TBil or AST\> double upper limit )
* have moderate and severe renal function abnormality(eGFR \< 50ml／min)
* blood leukocyte \<4.0×10\^9/L; blood thrombocyte\<90×10\^9/L
* taking drugs affecting glucose metabolism,such as glucocorticoid
* have other serious illness which considered to exacerbate and be life-threaten during fellow up period;
* have evidence of mental disorders;
* alcoholics and drug abuse
* females who were pregnant, lactating, planning for pregnancy, or sexually active but with no contraceptive measures;
* have participated in clinical trials within 3 months before;
* other conditions researchers thought to unable to evaluate the curative effect and finish the study.
* allergic to the ingredients of herbs contained in Tianqi capsule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02617732
Study Brief:
Protocol Section:
NCT02617732