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IRCT20200803048285N1 IRCT 2020-08-25 College of Pharmacy / University of Sulaimani effects of gingko biloba on the outcomes of metabolic syndrome The role of Gingko biloba extract as monotherapy in improving insulin resistance, BMI, VAI, leptin and level in patients with metabolic syndrome: A pilot comparative study with metformin 2020-05-01 anticipated 50 Complete https://irct.ir/trial/50087 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization of the individuals done using a shuffled deck of cards. 50 cards containing numbers starting from 1 to 50 and even numbers represent group A (Metformin) and odd numbers represent group B (Ginkgo biloba extract), Blinding description: The participants were not aware about the treatment (metformin or ginkgo biloba). The researcher and the outcome assessor also were not aware about the exact treatment they only had information of group A and B till the end of the study. 3 metabolic syndrome. Intervention 1: Intervention group ( metformin group): In this group the patients received 500 mg metformin as a single dose orally for 90 days. Intervention 2: Intervention group (Ginkgo biloba extract treated group): In this group the patients received 120 mg Ginkgo biloba extractas a single dose orally for 90 days. Yes - There is a plan to make this available What will be shared: Only the name of the patients will not be shared other wise all data will be available When: The data will be available after the end of the study and publishing the research article and the data will be available on request To whom: For all researchers in academic institutions and in in other research centers Conditions: for further researches about using alternative medicine in Metabolic Syndrome Where to obtain: contact the following : Tavga Ahmed Aziz College of Pharmacy University of Sulaimani tavga.aziz@univsul.edu.iq 009647701523544 How to obtain: By e-mail and/or phone Comments:
public Tavga Ahmed Aziz
House A30 / German Village 3
Sulaymaniyah Iraq 46001 +964 53 350 9692 tavga.aziz@univsul.edu.iq University of Sulaimani - College of Pharmacy scientific Tavga Ahmed Aziz
House A30 / German Village 3
Sulaymaniyah Iraq 46001 +964 53 350 9692 tavga.aziz@univsul.edu.iq University of Sulaimani - College of Pharmacy Iraq newly diagnosed as Metabolic syndrome both sexes 25 years 65 years Both pregnancy ischemic heart disease G6PD Deficiency bleeding disorders seizures allergy to the medications used in this trial E88.81 Metabolic syndrome Treatment - Drugs Treatment - Other Intervention group ( metformin group): In this group the patients received 500 mg metformin as a single dose orally for 90 days Intervention group (Ginkgo biloba extract treated group): In this group the patients received 120 mg Ginkgo biloba extractas a single dose orally for 90 days Glycemic status is the main outcome of the study and this include: fasting blood sugar, HbA1C, Insulin level, Insulin resistance,. Timepoint: At the time of first enrollment of the patient (zero time) and at the end of the study (after 90 days) of intervention. Method of measurement: The patients will be advised to be fasted for 12 hr and measurment of glycemic status will be performed by taking blood samples at the zero time and after 90 days of intervention and using lab kit to measure fasting blood glucose, HbA1c and insulin level. Insulin resistance will be calculated using HOMA-IR. Body mass index (BMI). Timepoint: At the time of first enrollment of the patient (zero time) and at the end of the study (after 90 days) of intervention. Method of measurement: BMI is calculated by using the following formula: weight (kg) / [height (m)]2. Height and weight are measured by an electronic scale and a wall-mounted stadiometer. Visceral adiposity index (VAI): The VAI is an empirical mathematical model, which is gender specific and based on simple anthropometric, BMI and waist circumference (WC) and functional parameters (TG and HDL-c), is an indicator of body fat distribution and function. Timepoint: At the time of first enrollment of the patient (zero time) and at the end of the study (after 90 days) of intervention. Method of measurement: Calculation of VAI is according to the formula given by Amato et al.24 The formula is a linear equation derived by extrapolation from the relationship between BMI and WC in a healthy normal/overweight population. Distribution mode of adipose tissue was corrected for TG and HDL-c levels to determine the VAI as follows: Female VAI = (WC/36.58 + (1.89 × BMI)) × (TG/0.81) × (1.52/HDL) Male VAI = (WC/39.68 + (1.88 × BMI)) × (TG/1.03) × (1.31/HDL) Where WC is expressed in cm, BMI in kg/m2, TG in mmol/L, and HDL in mmol/L. Leptin: It is one of the vital hormones expressed by the adipose tissue, and it has a critical role in regulating food consumption and energy production through its action on the hypothalamic nuclei. Timepoint: At the time of first enrollment of the patients (zero time) and at the end of the study (after 90 days of intervention). Method of measurement: The measurement of leptin level will be done using Elisa lab kit specific for leptin measurement. Safety profile of ginkgo biloba on the hematological markers: Hb(g/dl), Hct (%), RBC, WBC and palelets counts. Timepoint: At the time of first enrollment of the patients (zero time) and at the end of the study (after 90 days of intervention). Method of measurement: The hematological markers: Hb(g/dl), Hct (%), RBC, WBC and palelets counts are measured using lab kits. College of Pharmacy / University of Sulaimani Approved 2019-12-01 ethical committee of the University of Sulaimani Daniel Metran Street Sulaymaniyah Sulaymaniyah Iraq