Polycystic Ovary SyndromeNCT04932070
Berberine and Polycystic Ovary Syndrome
A study testing Berberine in people with Polycystic Ovary Syndrome and Berberine, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Berberine
- What is being tested?
- Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2020to 26 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal and overweight women (Body Mass Index (BMI) 25-30 kg/m2)
- newly detected Polycystic Ovary Syndrome
Who cannot join
- any concomitant medication
- presence of liver, renal and thyroid disease
- smoking
- drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Polycystic Ovary Syndrome, Berberine
- Being tested
- Berberine
- Keywords
- berberine, Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDietary supplement
2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets
| Study group | Role | What they receive |
|---|---|---|
| Berberine | Experimental | 2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets Receives: Dietary Supplement: Berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on insulin resistance
Homeostasis Model Assessment (pt), for evaluate insulin resistance if > 2.4
Measured: Changes from baseline insulin resistance at 8 weeks
Secondary outcomes (17)
Changes on inflammation
C-Reactive Protein (mg/dl)
Measured: Changes from baseline inflammation at 8 weeks
Changes on inflammation
Tumor Necrosis Factor alpha (pg/ml)
Measured: 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)
Measured: Changes from baseline lipid profile at 8 weeks
Changes on Carbohydrate profile
Glycemia (mg/dl)
Measured: Changes from baseline Carbohydrate profile at 8 weeks
Changes on Carbohydrate profile
Insulin (mcU/ml)
Measured: Changes from baseline Carbohydrate profile at 8 weeks
Changes on Hormonal profile
Sex Hormone Binding Globulin (nmol/l)
Measured: Changes from baseline Hormonal profile at 8 weeks
Changes on Hormonal profile
Testosterone (ng/ml)
Measured: Changes from baseline Hormonal profile at 8 weeks
Changes on Hormonal profile
Free Androgen Index (ratio)
Measured: Changes from baseline Hormonal profile at 8 weeks
Changes on safety
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
Measured: Changes from baseline safety at 8 weeks
Changes on safety
Total bilirubin (mg/dl)
Measured: Changes from baseline safety at 8 weeks
Changes on safety
Gamma Glutamyl Transferase (U/I), Creatine Phosphokinase (U/I)
Measured: Changes from baseline safety at 8 weeks
Changes on anthropometry
waist circumference (cm), hip circumference (cm)
Measured: Changes from baseline anthropometry at 8 weeks
Changes on anthropometry
Weight (kg)
Measured: Changes from baseline anthropometry at 8 weeks
Changes on anthropometry
Body Mass Index (Kg/m2)
Measured: Changes from baseline anthropometry at 8 weeks
Changes on body composition
Fat mass (g), lean mass (g), visceral adipose tissue (g)
Measured: 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
Measured: 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)
Measured: Changes from baseline acne assessment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start5 Sep 2020
- Primary completion6 Oct 2020
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932070
- Sponsor's protocol ID
- 1206/14122018
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04932070
- Acronym / sponsor ID
- 1206/14122018
- Conditions
- Polycystic Ovary Syndrome, Berberine
- Keywords
- berberine, Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Berberine | Experimental | Dietary Supplement: Berberine2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal and overweight women (Body Mass Index (BMI) 25-30 kg/m2)
- newly detected Polycystic Ovary Syndrome
Key exclusion criteria (4 listed)
- any concomitant medication
- presence of liver, renal and thyroid disease
- smoking
- drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berberine2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets | Dietary supplement | Berberine |
Primary outcome
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
17 secondary outcomes
Changes on inflammation
Time frame: Changes from baseline inflammation at 8 weeks
Changes on inflammation
Time frame: Changes from baseline inflammation at 8 weeks
Changes on lipid profile
Time frame: Changes from baseline lipid profile at 8 weeks
Changes on Carbohydrate profile
Time frame: Changes from baseline Carbohydrate profile at 8 weeks
Changes on Carbohydrate profile
Time frame: Changes from baseline Carbohydrate profile at 8 weeks
Changes on Hormonal profile
Time frame: Changes from baseline Hormonal profile at 8 weeks
Changes on Hormonal profile
Time frame: Changes from baseline Hormonal profile at 8 weeks
Changes on Hormonal profile
Time frame: Changes from baseline Hormonal profile at 8 weeks
Changes on safety
Time frame: Changes from baseline safety at 8 weeks
Changes on safety
Time frame: Changes from baseline safety at 8 weeks
Changes on safety
Time frame: Changes from baseline safety at 8 weeks
Changes on anthropometry
Time frame: Changes from baseline anthropometry at 8 weeks
Changes on anthropometry
Time frame: Changes from baseline anthropometry at 8 weeks
Changes on anthropometry
Time frame: Changes from baseline anthropometry at 8 weeks
Changes on body composition
Time frame: Changes from baseline body composition at 8 weeks
Changes on acne assessment
Time frame: Changes from baseline acne assessment at 8 weeks
Changes on acne assessment
Time frame: Changes from baseline acne assessment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine in people with Polycystic Ovary Syndrome and Berberine, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on insulin resistance (time frame: Changes from baseline insulin resistance at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.