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Completed

NCT Number: NCT04932070

Berberine and Polycystic Ovary Syndrome

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • normal and overweight women (Body Mass Index (BMI) 25-30 kg/m2)
  • newly detected Polycystic Ovary Syndrome

Exclusion criteria

  • any concomitant medication
  • presence of liver, renal and thyroid disease
  • smoking
  • drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Treatment and study plan

Berberine

Dietary Supplement

2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets

Primary outcomes

  1. Changes on insulin resistance

    Time frame: Changes from baseline insulin resistance at 8 weeks

    Homeostasis Model Assessment (pt), for evaluate insulin resistance if > 2.4

Secondary outcomes

  1. Changes on inflammation

    Time frame: Changes from baseline inflammation at 8 weeks

    C-Reactive Protein (mg/dl)

  2. Changes on inflammation

    Time frame: Changes from baseline inflammation at 8 weeks

    Tumor Necrosis Factor alpha (pg/ml)

  3. Changes on lipid profile

    Time frame: Changes from baseline lipid profile at 8 weeks

    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)

  4. Changes on Carbohydrate profile

    Time frame: Changes from baseline Carbohydrate profile at 8 weeks

    Glycemia (mg/dl)

  5. Changes on Carbohydrate profile

    Time frame: Changes from baseline Carbohydrate profile at 8 weeks

    Insulin (mcU/ml)

  6. Changes on Hormonal profile

    Time frame: Changes from baseline Hormonal profile at 8 weeks

    Sex Hormone Binding Globulin (nmol/l)

  7. Changes on Hormonal profile

    Time frame: Changes from baseline Hormonal profile at 8 weeks

    Testosterone (ng/ml)

  8. Changes on Hormonal profile

    Time frame: Changes from baseline Hormonal profile at 8 weeks

    Free Androgen Index (ratio)

  9. Changes on safety

    Time frame: Changes from baseline safety at 8 weeks

    Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)

  10. Changes on safety

    Time frame: Changes from baseline safety at 8 weeks

    Total bilirubin (mg/dl)

  11. Changes on safety

    Time frame: Changes from baseline safety at 8 weeks

    Gamma Glutamyl Transferase (U/I), Creatine Phosphokinase (U/I)

  12. Changes on anthropometry

    Time frame: Changes from baseline anthropometry at 8 weeks

    waist circumference (cm), hip circumference (cm)

  13. Changes on anthropometry

    Time frame: Changes from baseline anthropometry at 8 weeks

    Weight (kg)

  14. Changes on anthropometry

    Time frame: Changes from baseline anthropometry at 8 weeks

    Body Mass Index (Kg/m2)

  15. Changes on body composition

    Time frame: Changes from baseline body composition at 8 weeks

    Fat mass (g), lean mass (g), visceral adipose tissue (g)

  16. Changes on acne assessment

    Time frame: Changes from baseline acne assessment at 8 weeks

    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

  17. Changes on acne assessment

    Time frame: Changes from baseline acne assessment at 8 weeks

    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)

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

Berberine is an Effective Insulin Sensitizer and Improves Homeostasis of Metabolic and Hormonal Disorders in Women With Polycystic Ovary Syndrome: a Novel Treatment Strategy for PCOS

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 18, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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