Clinical trial NCT05480670: Treatment Benefits of Berberine Supplementation for Women With PCOS
Official title: Effect of Berberine Supplementation on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Ayub Teaching Hospital
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effect of Berberine on fasting blood glucose
timeFrame: up to 3 months
measure: Effect of Berberine on fasting blood insulin
timeFrame: up to 3 months
Secondary outcomes:
measure: Effect of Berberine on physical sign and symptoms associated with PCOS
timeFrame: up to 3 months
measure: Effect of Berberine on physical sign and symptoms associated with PCOS
timeFrame: up to 3 months
measure: Effect of Berberine on hormonal profile
timeFrame: up to 3 months
measure: Effect of Berberine on hormonal profile
timeFrame: up to 3 months
measure: Effect of Berberine on hormonal profile
timeFrame: up to 3 months
measure: Effect of Berberine on hormonal profile
timeFrame: up to 3 months
measure: Effect of Berberine on hormonal profile
timeFrame: up to 3 months
measure: Effect of Berberine on fasting lipid metabolic profile
timeFrame: up to 3 months
measure: Effect of Berberine on fasting lipid metabolic profile
timeFrame: up to 3 months
measure: Effect of Berberine on fasting lipid metabolic profile
timeFrame: up to 3 months
measure: Effect of Berberine on fasting lipid metabolic profile
timeFrame: up to 3 months
measure: Effect of Berberine on non-invasive markers of liver injury
timeFrame: up to 3 months
measure: Effect of Berberine on non-invasive markers of liver injury
timeFrame: up to 3 months
measure: Effect of Berberine on non-invasive markers of liver injury
timeFrame: up to 3 months
measure: Effect of Berberine on non-invasive markers of liver injury
timeFrame: up to 3 months
measure: Effect of Berberine on non-invasive markers of liver injury
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Ayub Teaching Hospital
state: KP
Study officials:
References: