type 2 diabetes mellitus. Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: diagnosis of type 2 diabetes (FBS =126 mg/dl, HbA1C =6.5%); type 2 diabetes patients under standard anti-diabetics agents; adult patients (18 to 65 year old). Exclusion criteria: pregnancy or breast feeding; lack of compliance with the study medication; impossibility to give informed consent; participation on an other concomitant clinical trial; presence of malignancies; chronic liver disease (ALT = 3 folds of upper limit of normal value range; renal failure (serum creatinine =2.0 mg/dL or on dialysis); subjects receiving hormonal agents; subjects receiving other herbal medicines; subjects with secondary causes of hyperglycemia (receiving steroids or with pancreatic cancer) subjects with acute infections or chronic inflammatory diseases (rheumatoid arthritis); hypersensitivity to the study medication; endocrine disease (hypothyroidism or hyperthyroidism); obsessive compulsive disorder.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting insulin. Timepoint: at baseline and 3 months after intervention. Method of measurement: pmol/L.;Fasting Blood Sugar. Timepoint: at baseline and 3 months after intervention. Method of measurement: mg/dl.;C peptide. Timepoint: at baseline and 3 months after intervention. Method of measurement: ng/ml.;HbA1C. Timepoint: at baseline and 3 months after intervention. Method of measurement: perecent.;MDA. Timepoint: at baseline and 3 months after intervention. Method of measurement: nmol/ml.;TNF-a. Timepoint: at baseline and 3 months after intervention. Method of measurement: pg/ml.;Superoxidase dismutase (SOD). Timepoint: at baseline and 3 months after intervention. Method of measurement: U/ml.;Plasma Total Antioxidant Capacity (TAO). Timepoint: at baseline and 3 months after intervention. Method of measurement: nmol/mg.;Leptin. Timepoint: at baseline and 3 months after intervention. Method of measurement: ng/ml.;Adiponectin. Timepoint: at baseline and 3 months after intervention. Method of measurement: ng/ml.;Ghreline. Timepoint: at baseline and 3 months after intervention. Method of measurement: pmol/L.;Glucagon like peptide-1. Timepoint: at baseline and 3 months after intervention. Method of measurement: pmol/L.;C Reactive Protein (CRP). Timepoint: at baseline and 3 months after intervention. Method of measurement: mg/dl. | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index (BMI). Timepoint: at the baseline and 3 month after treatment. Method of measurement: kg/m2.;Alanine transaminase (ALT). Timepoint: at the baseline and 3 month after treatment. Method of measurement: U/L.;Aspartate transaminase (AST). Timepoint: at the baseline and 3 month after treatment. Method of measurement: U/L.;Serum Creatinine. Timepoint: at the baseline and 3 month after treatment. Method of measurement: mg/dl. | — |
Countries
Iran (Islamic Republic of)
Contacts
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences