Treatment Benefits of Berberine Supplementation for Women With PCOS

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: Berberine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |