A Phase 4 interventional study of Fenugreek seeds extract 500 mg in Poly Cystic Ovary Syndrome, sponsored by Chemical Resources. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-06-03.
Sponsored by Chemical Resources · Phase 4, Interventional, and Supportive care
Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels. The genetically determined cause of the PCOS includes disturbed levels of insulin and androgens. Standardized fenugreek seed extract (Furocyst) contains compounds such as saponins \& flavonoids which act on the insulin and indirectly helps to regulate the androgen levels in the body.
Polycystic ovary syndrome is considered as clinical and public health consequence involving increase in number of cysts in women at reproductive age. These cysts are under-developed sacs in which eggs are developed. In PCOS, these sacs are unable to release an egg which means ovulation doesn't take place.
The estimated 5-10% prevalence of PCOS is reported in women of reproductive age. A study from Spain also reported that 28.3% prevalence rate of PCOS is among 113 overweight or obese women who were referred to an endocrinology clinic for weight loss. This data was compared with a previously reported prevalence of 6.5% which suggests that the prevalence of PCOS might be markedly increasing with obesity.
PCOS impacts significantly on various hormonal cycles. With PCOS, luteinizing hormone (LH) levels become higher than follicle stimulating hormone (FSH) levels. Because of this increase in LH levels, the LH surge does not take place and ovulation doesn't carry out which results in irregular menstrual cycle. The irregular menstrual period produces oligomenorrhea (few menstrual periods) or amenorrhea (no menstrual periods) and infertility due to irregular or lack of ovulation. PCOS also produces high levels of masculinizing hormones with symptoms of acne and hirsutism, hypermenorrhea involving heavy and prolonged menstrual periods and androgenic alopecia (increase hair thinning and diffused hair loss). The other metabolic syndromes associated with PCOS are increased risk of type 2 diabetes, high cholesterol levels and obesity.
These complications arise because of the genetically determined cause of the PCOS i.e. hyper- secretion of androgens from the ovary which favours excess luteinizing hormone (LH) secretion and insulin resistance. However, insulin resistance with or without a genetic mutation may be the initiator, followed by hyper-androgenism. Thus, insulin resistance is an important contributing factor to abnormal steroidogenesis in PCOS because hyper-insulinemia stimulates the pathway of insulin like growth factor-I (IGF-I) in theca cells of the ovary by cross-reacting with the receptors of IGF. Stimulation of the ovarian theca cells increases the production of androgens (eg, testosterone, androstenedione) which in turn, blocks the down-regulation of androgens by LH surge and leads to the hyper-androgenic environment in the ovary. Because of a decreased level of FSH relative to LH, the ovarian granulosa cells cannot aromatize the androgens to estrogens, which lead to decreased estrogen levels and results in anovulation.
Treatments for PCOS are chosen based on woman's symptoms, age and future pregnancy plans which may include birth control pills to regulate menstruation, insulin-sensitizing medications, ovulation induction to treat infertility, androgen-blocking medications, topical anti-hair-growth medications, etc.
Standardized fenugreek (Trigonella foenum graecum) seed extract (Furocyst) plays an important role in the management of PCOS. It improves glucose-tolerance and insulin-sensitivity, thereby promoting weight loss and moderation of androgen levels in the blood. Standardized fenugreek seeds extract contains a group of furostanolic saponins, derived from fenugreek seeds by an innovative process. It contains rich variety of saponins and flavonoids which have been known to lower the blood lipid levels and play valuable role in improving insulin sensitivity. Standardized fenugreek seeds extract is a dual insulin-sensitizer. In the presence of high fiber furostanolic saponins, cells become more sensitive to insulin \& an increase in number of insulin receptor sites occurs. These receptor sites are responsive to insulin to stimulate the cells ability to burn glucose. This decrease in insulin resistance helps in the management of PCOS.
Considering the beneficial effects of standardized fenugreek seed extract, present study was conducted to evaluate the efficacy of fenugreek seeds extract in patients with poly cystic ovary syndrome by assessing reduction in ovarian volume and decrease in the number of ovarian cysts.
Chemical Resources is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Furocyst one caps BID
Dietary Supplement: Fenugreek seeds extract 500 mg
Furocyst one caps BID
Also known as: Furocyst
Reduction in Ovary volume as assessed by ultrasound
volume in cubic cms
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
The record gives a start of Sep 2013, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chemical Resources