Berberine is a plant alkaloid, reportedly possesses a wide range of pharmacological activities, including anti-obesity and anti-dyslipidemia. Berberine is an effective insulin sensitizer and has a comparable activity to MET in reducing IR. A large body of evidence suggest that Berberine dietary supplementation helps in improvement of symptoms associated with Polycystic Ovary Syndrome (PCOS). The purpose of this study is to investigate the treatment benefits of Berberine in women with PCOS.
Berberine (BBR) is an isoquinoline derivative alkaloid that occurs in several plants including Oregon grape, barberry, tree turmeric, goldenseal, yellowroot, Amur corktree, Chinese goldthread, prickly poppy and Californian poppy. Berberine supplementation has been suggested to improve the symptoms associated with PCOS. Berberine; Reduces Insulin Resistance Lowers Blood Sugar Levels Aids in Weight Loss Improves Cholesterol Levels Regulates Menstrual Cycles Reduces Inflammation Helps Restore Hormonal Balance Improves Fertility Helps Combat Depression Helps Fight Fatty Liver Disease Improves Body Composition The present RCT is aimed to investigate the effect of Berberine on these symptoms associated with PCOS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
550 mg Berberine supplement BDS for 3-months + changes in diet/life style.
Ayub Teaching Hospital
Abbottabad, Khyber Pakhtunkhwa, Pakistan
Effect of Berberine on fasting blood glucose
Time frame: up to 3 months
Effect of Berberine on fasting blood insulin
Time frame: up to 3 months
Effect of Berberine on physical sign and symptoms associated with PCOS
Effect on Hirsutism
Time frame: up to 3 months
Effect of Berberine on physical sign and symptoms associated with PCOS
Effect on Acne
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Total testosterone
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Sex hormone-binding globulin (SHBG)
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Follicle stimulating hormone (FSH)
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Luteinizing hormone (LH)
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Anti-Mullerian hormone (AMH)
Time frame: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
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Total cholesterol
Time frame: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Total triglycerides (TG)
Time frame: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
High density lipoprotein cholesterol (HDL-C)
Time frame: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Low density lipoprotein cholesterol (LDL-C)
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
ALT
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
AST
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Gamma GT
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Bilirubin
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Alkaline phosphatase (ALP)
Time frame: up to 3 months