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Completed

NCT Number: NCT05480670

Treatment Benefits of Berberine Supplementation for Women With 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ayub Teaching Hospital

Abbottabad, Khyber Pakhtunkhwa, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Berberine

Dietary Supplement

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

Primary outcomes

  1. Effect of Berberine on fasting blood glucose

    Time frame: up to 3 months

  2. Effect of Berberine on fasting blood insulin

    Time frame: up to 3 months

Secondary outcomes

  1. Effect of Berberine on physical sign and symptoms associated with PCOS

    Time frame: up to 3 months

    Effect on Hirsutism

  2. Effect of Berberine on physical sign and symptoms associated with PCOS

    Time frame: up to 3 months

    Effect on Acne

  3. Effect of Berberine on hormonal profile

    Time frame: up to 3 months

    Total testosterone

  4. Effect of Berberine on hormonal profile

    Time frame: up to 3 months

    Sex hormone-binding globulin (SHBG)

  5. Effect of Berberine on hormonal profile

    Time frame: up to 3 months

    Follicle stimulating hormone (FSH)

  6. Effect of Berberine on hormonal profile

    Time frame: up to 3 months

    Luteinizing hormone (LH)

  7. Effect of Berberine on hormonal profile

    Time frame: up to 3 months

    Anti-Mullerian hormone (AMH)

  8. Effect of Berberine on fasting lipid metabolic profile

    Time frame: up to 3 months

    Total cholesterol

  9. Effect of Berberine on fasting lipid metabolic profile

    Time frame: up to 3 months

    Total triglycerides (TG)

  10. Effect of Berberine on fasting lipid metabolic profile

    Time frame: up to 3 months

    High density lipoprotein cholesterol (HDL-C)

  11. Effect of Berberine on fasting lipid metabolic profile

    Time frame: up to 3 months

    Low density lipoprotein cholesterol (LDL-C)

  12. Effect of Berberine on non-invasive markers of liver injury

    Time frame: up to 3 months

    ALT

  13. Effect of Berberine on non-invasive markers of liver injury

    Time frame: up to 3 months

    AST

  14. Effect of Berberine on non-invasive markers of liver injury

    Time frame: up to 3 months

    Gamma GT

  15. Effect of Berberine on non-invasive markers of liver injury

    Time frame: up to 3 months

    Bilirubin

  16. Effect of Berberine on non-invasive markers of liver injury

    Time frame: up to 3 months

    Alkaline phosphatase (ALP)

Sponsors and collaborators

Lead sponsor

Ayub Teaching Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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