Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome
Condition: Poly Cystic Ovary Syndrome
MeSH terms: Ovarian Cysts; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fenugreek seeds extract 500 mg
Intervention type(s): Dietary Supplement
Intervention description(s): Furocyst one caps BID
Other intervention name(s): Furocyst
Intervention MeSH terms: Fenugreek seed meal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care