An interventional study of Berberine in Polycystic Ovary Syndrome and Berberine, sponsored by Azienda di Servizi alla Persona di Pavia. Completed at 1 site in Italy. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Azienda di Servizi alla Persona di Pavia · Not applicable, Interventional, and Treatment
Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's enrollment of 12 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Azienda di Servizi alla Persona di Pavia is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets
Dietary Supplement: Berberine
2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets
Changes on insulin resistance
Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2.4
Time frame: Changes from baseline insulin resistance at 8 weeks
Changes on inflammation
C-Reactive Protein (mg/dl)
Time frame: Changes from baseline inflammation at 8 weeks
Changes on inflammation
Tumor Necrosis Factor alpha (pg/ml)
Time frame: Changes from baseline inflammation at 8 weeks
Changes on lipid profile
Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Very Low Density Lipoprotein (mg/dl),Triglycerides (mg/dl)
Time frame: Changes from baseline lipid profile at 8 weeks
Changes on Carbohydrate profile
Glycemia (mg/dl)
Time frame: Changes from baseline Carbohydrate profile at 8 weeks
Changes on Carbohydrate profile
Insulin (mcU/ml)
Time frame: Changes from baseline Carbohydrate profile at 8 weeks
Changes on Hormonal profile
Sex Hormone Binding Globulin (nmol/l)
Time frame: Changes from baseline Hormonal profile at 8 weeks
Changes on Hormonal profile
Testosterone (ng/ml)
Time frame: Changes from baseline Hormonal profile at 8 weeks
Changes on Hormonal profile
Free Androgen Index (ratio)
Time frame: Changes from baseline Hormonal profile at 8 weeks
Changes on safety
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
Time frame: Changes from baseline safety at 8 weeks
Changes on safety
Total bilirubin (mg/dl)
Time frame: Changes from baseline safety at 8 weeks
Changes on safety
Gamma Glutamyl Transferase (U/I), Creatine Phosphokinase (U/I)
Time frame: Changes from baseline safety at 8 weeks
Changes on anthropometry
waist circumference (cm), hip circumference (cm)
Time frame: Changes from baseline anthropometry at 8 weeks
Changes on anthropometry
Weight (kg)
Time frame: Changes from baseline anthropometry at 8 weeks
Changes on anthropometry
Body Mass Index (Kg/m2)
Time frame: Changes from baseline anthropometry at 8 weeks
Changes on body composition
Fat mass (g), lean mass (g), visceral adipose tissue (g)
Time frame: Changes from baseline body composition at 8 weeks
Changes on acne assessment
Global Acne Grading System (scale): each type of acne lesion is given a value depending on severity: no lesions = 0, comedones = 1, papules = 2, pustules = 3, and nodules = 4. Each of the location was graded separately on 0-4 scale, with the most severe lesion within that location determining the local score. The severity was then graded according to the global score which is the summation of all local scores. A score of 1-6 was considered mild; 7-18, moderate; 19- 26, severe; and 27-32, very severe. The maximum score was 32
Time frame: Changes from baseline acne assessment at 8 weeks
Changes on acne assessment
Cardiff Acne Disability Index (scale): the Cardiff Acne Disability Index consists of five questions with a Likert scale, four response categories (0-3). The five questions relate to feeling of aggression, frustration, interference with social life, avoidance of public changing facilities and appearance of the skin-all over the last month-and an indication of how bad the acne was now. The CADI score was calculated by summing the score of each question resulting in a possible maximum of 15 and minimum of 0. CADI scores were graded as low (0-4), medium (5-9), and high (10-15)
Time frame: Changes from baseline acne assessment at 8 weeks
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Berberine
Azienda di Servizi alla Persona di Pavia