Treatment Benefits of Berberine Supplementation for Women With PCOS
Effect of Berberine Supplementation on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS)
1 other identifier
interventional
120
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2023
CompletedMay 18, 2023
May 1, 2023
5 months
July 24, 2022
May 16, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Effect of Berberine on fasting blood glucose
up to 3 months
Effect of Berberine on fasting blood insulin
up to 3 months
Secondary Outcomes (16)
Effect of Berberine on physical sign and symptoms associated with PCOS
up to 3 months
Effect of Berberine on physical sign and symptoms associated with PCOS
up to 3 months
Effect of Berberine on hormonal profile
up to 3 months
Effect of Berberine on hormonal profile
up to 3 months
Effect of Berberine on hormonal profile
up to 3 months
- +11 more secondary outcomes
Study Arms (2)
Berberine arm
EXPERIMENTALParticipants 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 INTERVENTIONParticipants in this group will undergo changes in their diet/life-style.
Interventions
550 mg Berberine supplement BDS for 3-months + changes in diet/life style.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ayub Teaching Hospital
Abbottabad, Khyber Pakhtunkhwa, Pakistan
Related Publications (1)
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.
PMID: 38074133DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2022
First Posted
July 29, 2022
Study Start
November 1, 2022
Primary Completion
March 31, 2023
Study Completion
April 15, 2023
Last Updated
May 18, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share