Treatment Benefits of Berberine Supplementation for Women With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effect of Berberine Supplementation on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05480670
• Other study ID #: Ref. No. RC-2022/EA-01/178
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: May 2023
• Source: Ayub Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 15, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Pakistan	Ayub Teaching Hospital	Abbottabad	KP

Sponsors (1)

Lead Sponsor	Collaborator
Ayub Teaching Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

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