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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200803048285N1

Enrollment

Registered

2020-08-25

Start date

2020-05-01

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic syndrome. Metabolic syndrome

Interventions

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 extra

Eligibility

Sex/Gender

All

Age

25 Years to 65 Years

Inclusion criteria

Inclusion criteria: newly diagnosed as Metabolic syndrome both sexes

Exclusion criteria

Exclusion criteria: pregnancy ischemic heart disease G6PD Deficiency bleeding disorders seizures allergy to the medications used in this trial

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iraq

Contacts

Public ContactTavga Ahmed Aziz

University of Sulaimani - College of Pharmacy

tavga.aziz@univsul.edu.iq+964 53 350 9692

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026