Back to resultsTreatment Benefits of Berberine Supplementation for Women With PCOS
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Berberine
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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
Sites / Locations
- Ayub Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Berberine arm
Control arm
Arm Description
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.
Participants in this group will undergo changes in their diet/life-style.
Outcomes
Primary Outcome Measures
Effect of Berberine on fasting blood glucose
Effect of Berberine on fasting blood insulin
Secondary Outcome Measures
Effect of Berberine on physical sign and symptoms associated with PCOS
Effect on Hirsutism
Effect of Berberine on physical sign and symptoms associated with PCOS
Effect on Acne
Effect of Berberine on hormonal profile
Total testosterone
Effect of Berberine on hormonal profile
Sex hormone-binding globulin (SHBG)
Effect of Berberine on hormonal profile
Follicle stimulating hormone (FSH)
Effect of Berberine on hormonal profile
Luteinizing hormone (LH)
Effect of Berberine on hormonal profile
Anti-Mullerian hormone (AMH)
Effect of Berberine on fasting lipid metabolic profile
Total cholesterol
Effect of Berberine on fasting lipid metabolic profile
Total triglycerides (TG)
Effect of Berberine on fasting lipid metabolic profile
High density lipoprotein cholesterol (HDL-C)
Effect of Berberine on fasting lipid metabolic profile
Low density lipoprotein cholesterol (LDL-C)
Effect of Berberine on non-invasive markers of liver injury
ALT
Effect of Berberine on non-invasive markers of liver injury
AST
Effect of Berberine on non-invasive markers of liver injury
Gamma GT
Effect of Berberine on non-invasive markers of liver injury
Bilirubin
Effect of Berberine on non-invasive markers of liver injury
Alkaline phosphatase (ALP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05480670
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ayub Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Berberine arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Participants in this group will undergo changes in their diet/life-style.
Intervention Type
Dietary Supplement
Intervention Name(s)
Berberine
Intervention Description
550 mg Berberine supplement BDS for 3-months + changes in diet/life style.
Primary Outcome Measure Information:
Title
Effect of Berberine on fasting blood glucose
Time Frame
up to 3 months
Title
Effect of Berberine on fasting blood insulin
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Effect of Berberine on physical sign and symptoms associated with PCOS
Description
Effect on Hirsutism
Time Frame
up to 3 months
Title
Effect of Berberine on physical sign and symptoms associated with PCOS
Description
Effect on Acne
Time Frame
up to 3 months
Title
Effect of Berberine on hormonal profile
Description
Total testosterone
Time Frame
up to 3 months
Title
Effect of Berberine on hormonal profile
Description
Sex hormone-binding globulin (SHBG)
Time Frame
up to 3 months
Title
Effect of Berberine on hormonal profile
Description
Follicle stimulating hormone (FSH)
Time Frame
up to 3 months
Title
Effect of Berberine on hormonal profile
Description
Luteinizing hormone (LH)
Time Frame
up to 3 months
Title
Effect of Berberine on hormonal profile
Description
Anti-Mullerian hormone (AMH)
Time Frame
up to 3 months
Title
Effect of Berberine on fasting lipid metabolic profile
Description
Total cholesterol
Time Frame
up to 3 months
Title
Effect of Berberine on fasting lipid metabolic profile
Description
Total triglycerides (TG)
Time Frame
up to 3 months
Title
Effect of Berberine on fasting lipid metabolic profile
Description
High density lipoprotein cholesterol (HDL-C)
Time Frame
up to 3 months
Title
Effect of Berberine on fasting lipid metabolic profile
Description
Low density lipoprotein cholesterol (LDL-C)
Time Frame
up to 3 months
Title
Effect of Berberine on non-invasive markers of liver injury
Description
ALT
Time Frame
up to 3 months
Title
Effect of Berberine on non-invasive markers of liver injury
Description
AST
Time Frame
up to 3 months
Title
Effect of Berberine on non-invasive markers of liver injury
Description
Gamma GT
Time Frame
up to 3 months
Title
Effect of Berberine on non-invasive markers of liver injury
Description
Bilirubin
Time Frame
up to 3 months
Title
Effect of Berberine on non-invasive markers of liver injury
Description
Alkaline phosphatase (ALP)
Time Frame
up to 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ayub Teaching Hospital
City
Abbottabad
State/Province
KP
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment Benefits of Berberine Supplementation for Women With PCOS
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