title: Efficacy of a Novel Fenugreek Seed Extract (Trigonella foenum-graecum, Furocyst) in Polycystic Ovary Syndrome (PCOS).
abstract: Polycystic ovary syndrome (PCOS) is one of the most prevalent hormonal disorders among women of reproductive age causing irregular menstrual cycles, excessive body or facial hair, miscarriage and infertility. The latter being a most common PCOS symptoms. Because the symptoms are seemingly unrelated to one another, PCOS is often overlooked and undiagnosed. The present study is an open label, one-arm, non-randomized, post-marketing surveillance study in 50 premenopausal women (18-45 years, BMI<42) diagnosed with PCOS using a novel Trigonella foenum-graecum seed extract (fenugreek seed extract, Furocyst, 2 capsules of 500 mg each/day) extract, enriched in approximately 40% furostanolic saponins, over a period of 90 consecutive days. The study was conducted to determine its efficacy on the reduction of ovarian volume and the number of ovarian cysts. Ethical committee approval was obtained for this study. Furocyst treatment caused significant reduction in ovary volume. Approximately 46% of study population showed reduction in cyst size, while 36% of subjects showed complete dissolution of cyst. It is important to mention that 71% of subjects reported the return of regular menstrual cycle on completion of the treatment and 12% of subjects subsequently became pregnant. Overall, 94% of patients benefitted from the regimen. Significant increases in luteinizing hormone (LH) and follicular stimulating hormone (FSH) levels were observed compared to the baseline values. Extensive blood chemistry, hematological and biochemical assays demonstrated the broad-spectrum safety. Furocyst caused significant decrease in both ovarian volume and the number of ovarian cysts. Serum ALT, BUN and CK were assessed to demonstrate the broad-spectrum safety of Furocyst. No significant adverse effects were observed. In summary, Furocyst was efficacious in ameliorating the symptoms of PCOS.
authors.affiliation: 1. Cepham Research Center, Piscataway, NJ, USA.
authors.forename: Anand
authors.initials: A
authors.lastname: Swaroop
authors.affiliation: 2. Jaipuriar Cardiac Center and Garg Hospital, Gorakhpur, Uttar Pradesh, India.
authors.forename: Amrita Sarkari
authors.initials: AS
authors.lastname: Jaipuriar
authors.affiliation: 3. Hormone and Maternity Clinic, Meerut, Uttar Pradesh, India.
authors.forename: Sushil Kumar
authors.initials: SK
authors.lastname: Gupta
authors.affiliation: 1. Cepham Research Center, Piscataway, NJ, USA.
authors.forename: Manashi
authors.initials: M
authors.lastname: Bagchi
authors.affiliation: 4. Chemical Resources, Panchkula, Haryana, India.
authors.forename: Pawan
authors.initials: P
authors.lastname: Kumar
authors.affiliation: 5. Departments of Biochemistry, Medicine and Pathology, Georgetown University Medical Center, Washington, DC, USA.
authors.forename: Harry G
authors.initials: HG
authors.lastname: Preuss
authors.affiliation: 1. Cepham Research Center, Piscataway, NJ, USA ; 6. Department of Pharmacological and Pharmaceutical Sciences, University of Houston College of Pharmacy, Houston, TX, USA.
authors.forename: Debasis
authors.initials: D
authors.lastname: Bagchi
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007958:Leukocyte Count; D007986:Luteinizing Hormone / Q000097:blood; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000188:drug therapy*; D029910:Trigonella; D055815:Young Adult
chemical_list: D006454:Hemoglobins; D010936:Plant Extracts; C056164:fenugreek seed meal; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone
keywords: Fenugreek seed extract (Furocyst); cyst size; female subjects; luteinizing (LH) and follicular stimulating hormone (FSH); polycystic ovary syndrome (PCOS); safety