Treatment Benefits of Berberine Supplementation for Women With PCOS

NCT ID: NCT05480670

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Berberine arm

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.

Group Type: EXPERIMENTAL

Berberine

Intervention Type: DIETARY_SUPPLEMENT

550 mg Berberine supplement BDS for 3-months + changes in diet/life style.

Control arm

Participants in this group will undergo changes in their diet/life-style.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Berberine

550 mg Berberine supplement BDS for 3-months + changes in diet/life style.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Women aged between 18 and 45 years

2. 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

3. Normal, over-weight, and obese class I women (BMI 18.5 - 29.9 kg/m2, BMI cut-off as per the Asian criteria)

4. With no desire for pregnancy within 6 months

5. Able to give informed written consent

Exclusion Criteria

1. 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.

2. Women undergoing in vitro fertilization treatment.

3. Women diagnosed with lateonset congenital adrenal hyperplasia (17-OH progestrone), thyroid disorders, hyperprolactinemia, diabetes mellitus and ODST.

4. Presence of liver, or renal disease

5. Pregnant or lactating or menopause women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ayub Teaching Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ayub Teaching Hospital

Abbottabad, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 38074133 (View on PubMed)

Other Identifiers

Ref. No. RC-2022/EA-01/178

Identifier Type: -

Identifier Source: org_study_id