Berberine and Polycystic Ovary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-05

Study Completion Date

2021-01-26

Brief Summary

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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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Detailed Description

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Conditions

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Polycystic Ovary Syndrome Berberine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Berberine

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

Group Type EXPERIMENTAL

Berberine

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Berberine

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes