Polycystic Ovary SyndromeNCT05480670
Treatment Benefits of Berberine Supplementation for Women With PCOS
A study testing Berberine in people with Polycystic Ovary Syndrome, run by Ayub Teaching Hospital at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- 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
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 15 Apr 2023
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 18 and 45 years
- PCOS diagnosis as per the Rotterdam Criteria (any two of the following features:
- Irregular periods (allso called oligomenorrea) or no periods (amenorrhea),
- Higher levels of andregens present in the blood (hyperandrogenism), or physical characteristics of elevated andregen levels such as acne, male-pattern balding, or excess hair growth on face, chin, or body
- Polycystic ovaries visible on an ultrasound
- Normal, over-weight, and obese class I women (BMI 18.5 - 29.9 kg/m2, BMI cut-off as per the Asian criteria)
- With no desire for pregnancy within 6 months
- Able to give informed written consent
Who cannot join
- Women who are currently taking or have teken in the last three months medications known to alter insulin physiology, oral contraceptives, ovulation induction drugs, anti- obesity or cholestrol lowering drugs, or any supplement known to interfere with insulin and androgen metabolism such as inositols, curcumin, lipoic acid, cinnamon, gymnemic and other botanical extracts.
- Women undergoing in vitro fertilization treatment.
- Women diagnosed with lateonset congenital adrenal hyperplasia (17-OH progestrone), thyroid disorders, hyperprolactinemia, diabetes mellitus and ODST.
- Presence of liver, or renal disease
- Pregnant or lactating or menopause women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Berberine Supplementation on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS)
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.
Read the detailed description
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Berberine
- 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
550 mg Berberine supplement BDS for 3-months + changes in diet/life style.
| Study group | Role | What they receive |
|---|---|---|
| Berberine arm | Experimental | Participants in this group will receive an oral 550 mg Berberine supplement tablet BDS for 3-months as an add-on to the changes in the diet/life-style for 3-months. The changes in the diet/life-style include limiting fat and carbohydrate intake and improve dietary behavior without the application of a calorie-restricted diet program. Exercise will also be recommended to include 30 min/day of moderate to intense activity. Receives: Dietary Supplement: Berberine |
| Control arm | No intervention | Participants in this group will undergo changes in their diet/life-style. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Berberine on fasting blood glucose
Measured: up to 3 months
Effect of Berberine on fasting blood insulin
Measured: up to 3 months
Secondary outcomes (16)
Effect of Berberine on physical sign and symptoms associated with PCOS
Effect on Hirsutism
Measured: up to 3 months
Effect of Berberine on physical sign and symptoms associated with PCOS
Effect on Acne
Measured: up to 3 months
Effect of Berberine on hormonal profile
Total testosterone
Measured: up to 3 months
Effect of Berberine on hormonal profile
Sex hormone-binding globulin (SHBG)
Measured: up to 3 months
Effect of Berberine on hormonal profile
Follicle stimulating hormone (FSH)
Measured: up to 3 months
Effect of Berberine on hormonal profile
Luteinizing hormone (LH)
Measured: up to 3 months
Effect of Berberine on hormonal profile
Anti-Mullerian hormone (AMH)
Measured: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Total cholesterol
Measured: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Total triglycerides (TG)
Measured: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
High density lipoprotein cholesterol (HDL-C)
Measured: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Low density lipoprotein cholesterol (LDL-C)
Measured: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
ALT
Measured: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
AST
Measured: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Gamma GT
Measured: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Bilirubin
Measured: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Alkaline phosphatase (ALP)
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Nov 2022
- Primary completion31 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayub Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480670
- Sponsor's protocol ID
- Ref. No. RC-2022/EA-01/178
- Status last verified
- May 2023
- First submitted
- 24 Jul 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Pierro F, Sultana R, Eusaph AZ, Abrar S, Bugti M, Afridi F, Farooq U, Iqtadar S, Ghauri F, Makhduma S, Nourin S, Kanwal A, Bano A, Bugti AA, Mureed S, Ghazal A, Irshad R, Recchia M, Bertuccioli A, Putignano P, Riva A, Guasti L, Zerbinati N, Khan A. Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial. Front Pharmacol. 2023 Nov 21;14:1269605. doi: 10.3389/fphar.2023.1269605. eCollection 2023.
PubMed 38074133
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Berberine Supplementation on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT05480670
- Acronym / sponsor ID
- Ref. No. RC-2022/EA-01/178
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ayub Teaching HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 29 Jul 2022 (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.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine arm | Experimental | Dietary Supplement: BerberineParticipants in this group will receive an oral 550 mg Berberine supplement tablet BDS for 3-months as an add-on to the changes in the diet/life-style for 3-months. The changes in the diet/life-style include limiting fat and carbohydrate intake and improve dietary behavior without the application of a calorie-restricted diet program. Exercise will also be recommended to include 30 min/day of moderate to intense activity. |
| Control arm | No intervention | –Participants in this group will undergo changes in their diet/life-style. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women aged between 18 and 45 years
- PCOS diagnosis as per the Rotterdam Criteria (any two of the following features:
- Normal, over-weight, and obese class I women (BMI 18.5 - 29.9 kg/m2, BMI cut-off as per the Asian criteria)
- With no desire for pregnancy within 6 months
- Able to give informed written consent
Key exclusion criteria (5 listed)
- Women who are currently taking or have teken in the last three months medications known to alter insulin physiology, oral contraceptives, ovulation induction drugs, anti- obesity or cholestrol lowering drugs, or any supplement known to interfere with insulin and androgen metabolism such as inositols, curcumin, lipoic acid, cinnamon, gymnemic and other botanical extracts.
- Women undergoing in vitro fertilization treatment.
- Women diagnosed with lateonset congenital adrenal hyperplasia (17-OH progestrone), thyroid disorders, hyperprolactinemia, diabetes mellitus and ODST.
- Presence of liver, or renal disease
- Pregnant or lactating or menopause women
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 |
|---|---|---|
| Berberine550 mg Berberine supplement BDS for 3-months + changes in diet/life style. | Dietary supplement | Berberine arm |
Primary outcome
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
16 secondary outcomes
Effect of Berberine on physical sign and symptoms associated with PCOS
Time frame: up to 3 months
Effect of Berberine on physical sign and symptoms associated with PCOS
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Time frame: up to 3 months
Effect of Berberine on hormonal profile
Time frame: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Time frame: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Time frame: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Time frame: up to 3 months
Effect of Berberine on fasting lipid metabolic profile
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Time frame: up to 3 months
Effect of Berberine on non-invasive markers of liver injury
Time frame: up to 3 months
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 May 2023.
- Derived from this study: PubMed 38074133Di Pierro F, Sultana R, Eusaph AZ, Abrar S, Bugti M, Afridi F, Farooq U, Iqtadar S, Ghauri F, Makhduma S, Nourin S, Kanwal A, Bano A, Bugti AA, Mureed S, Ghazal A, Irshad R, Recchia M, Bertuccioli A, Putignano P, Riva A, Guasti L, Zerbinati N, Khan A. Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial. Front Pharmacol. 2023 Nov 21;14:1269605. doi: 10.3389/fphar.2023.1269605. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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, run by Ayub Teaching Hospital at 1 site in Pakistan.
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 8 inclusion and 5 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 May 2023. 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 Pakistan. 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?
Effect of Berberine on fasting blood glucose (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05480670, which also lists 1 linked publication.
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 May 2023.