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)

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Dietary supplement: Berberine

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Somia Iqtadar, MBBS; Phone Number: + 92 3214296189; Email: somia.iqtadar@gmail.com

Study Locations

• Pakistan
  • KP
    • Abbottabad, KP, Pakistan
      • Ayub Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Berberine; 550 mg Berberine supplement BDS for 3-months + changes in diet/life style.
No Intervention: Control arm; Participants in this group will undergo changes in their diet/life-style.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of Berberine on fasting blood glucose	up to 3 months
Effect of Berberine on fasting blood insulin	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Berberine on physical sign and symptoms associated with PCOS	Effect on Hirsutism	up to 3 months
Effect of Berberine on physical sign and symptoms associated with PCOS	Effect on Acne	up to 3 months
Effect of Berberine on hormonal profile	Total testosterone	up to 3 months
Effect of Berberine on hormonal profile	Sex hormone-binding globulin (SHBG)	up to 3 months
Effect of Berberine on hormonal profile	Follicle stimulating hormone (FSH)	up to 3 months
Effect of Berberine on hormonal profile	Luteinizing hormone (LH)	up to 3 months
Effect of Berberine on hormonal profile	Anti-Mullerian hormone (AMH)	up to 3 months
Effect of Berberine on fasting lipid metabolic profile	Total cholesterol	up to 3 months
Effect of Berberine on fasting lipid metabolic profile	Total triglycerides (TG)	up to 3 months
Effect of Berberine on fasting lipid metabolic profile	High density lipoprotein cholesterol (HDL-C)	up to 3 months
Effect of Berberine on fasting lipid metabolic profile	Low density lipoprotein cholesterol (LDL-C)	up to 3 months
Effect of Berberine on non-invasive markers of liver injury	ALT	up to 3 months
Effect of Berberine on non-invasive markers of liver injury	AST	up to 3 months
Effect of Berberine on non-invasive markers of liver injury	Gamma GT	up to 3 months
Effect of Berberine on non-invasive markers of liver injury	Bilirubin	up to 3 months
Effect of Berberine on non-invasive markers of liver injury	Alkaline phosphatase (ALP)	up to 3 months

Collaborators and Investigators

• Sponsor: Ayub Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: Ref. No. RC-2022/EA-01/178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No