Treatment Benefits of Berberine Supplementation for Women With PCOS

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Berberine

• Registration Number: NCT05480670
• Lead Sponsor: Ayub Teaching Hospital

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.

Study Timeline

• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Study Start: 2022-11-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Berberine arm	Berberine	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.

Primary Outcome Measures

Name	Time	Method
Effect of Berberine on fasting blood insulin	up to 3 months
Effect of Berberine on fasting blood glucose	up to 3 months

Secondary Outcome Measures

Name	Time	Method
Effect of Berberine on physical sign and symptoms associated with PCOS	up to 3 months	Effect on Acne
Effect of Berberine on hormonal profile	up to 3 months	Anti-Mullerian hormone (AMH)
Effect of Berberine on fasting lipid metabolic profile	up to 3 months	Low density lipoprotein cholesterol (LDL-C)
Effect of Berberine on non-invasive markers of liver injury	up to 3 months	Alkaline phosphatase (ALP)

Trial Locations

Locations (1)

Ayub Teaching Hospital; 🇵🇰 Abbottabad, KP, Pakistan