Poly Cystic Ovary SyndromePhase 4NCT02789488
Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome
A Phase 4 study testing Fenugreek seeds extract 500 mg in people with Poly Cystic Ovary Syndrome, run by Chemical Resources.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Poly Cystic Ovary Syndrome
- What is being tested?
- Fenugreek seeds extract 500 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women between 18-45 years of age and BMI less than 42
- Diagnosed with PCOS
- Adequate hepatic, renal and hematological functions
- Patients willing to give informed consent in writing
Who cannot join
- Males
- Post menopausal women
- Women with hysterectomy
- Patients with congenital adrenal hyperplasia
- Patients suffering from Cushing's syndrome
- Patients diagnosed with androgen secreting tumors
Show all 9Show fewer
- Patients with thyroid dysfunction (T3, T4 level is higher than that in normal women of reproductive age)
- Patients with Hypo-gonadotropic and Hypo-gonadism (central origin of ovarian dysfunction)
- Pregnancy or desire for pregnancy or lactating mothers
About this study
Official title: Efficacy and Safety of Furocyst in Patients With Poly Cystic Ovary Syndrome
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.
Read the 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.
- Conditions
- Poly Cystic Ovary Syndrome
- Being tested
- Fenugreek seeds extract 500 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenugreek seeds extract 500 mgDietary supplement
Also called Furocyst
Furocyst one caps BID
| Study group | Role | What they receive |
|---|---|---|
| Furocyst | Other | Furocyst one caps BID Receives: Dietary Supplement: Fenugreek seeds extract 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Ovary volume as assessed by ultrasound
volume in cubic cms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Poly Cystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemical Resources
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Amrita Sarkari Jaipuriar, MS, Principal investigator, Garg Hospital,Goalghar .Gorakhpur,UP,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789488
- Sponsor's protocol ID
- CR001/PCOS-5-13
- Status last verified
- Sep 2013
- First submitted
- 20 Apr 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
PubMed 15788499Schroder AK, Tauchert S, Ortmann O, Diedrich K, Weiss JM. [Insulin resistance in polycystic ovary syndrome]. Wien Klin Wochenschr. 2003 Dec 15;115(23):812-21. doi: 10.1007/BF03041041. German.
PubMed 14740344Hassanzadeh Bashtian M, Emami SA, Mousavifar N, Esmaily HA, Mahmoudi M, Mohammad Poor AH. Evaluation of Fenugreek (Trigonella foenum-graceum L.), Effects Seeds Extract on Insulin Resistance in Women with Polycystic Ovarian Syndrome. Iran J Pharm Res. 2013 Spring;12(2):475-81.
PubMed 24250624
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Furocyst in Patients With Poly Cystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02789488
- Acronym / sponsor ID
- CR001/PCOS-5-13
- Conditions
- Poly Cystic Ovary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chemical ResourcesIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furocyst | Other | Dietary Supplement: Fenugreek seeds extract 500 mgFurocyst one caps BID |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal women between 18-45 years of age and BMI less than 42
- Diagnosed with PCOS
- Adequate hepatic, renal and hematological functions
- Patients willing to give informed consent in writing
Key exclusion criteria (9 listed)
- Males
- Post menopausal women
- Women with hysterectomy
- Patients with congenital adrenal hyperplasia
- Patients suffering from Cushing's syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenugreek seeds extract 500 mgAlso: FurocystFurocyst one caps BID | Dietary supplement | Furocyst |
Primary outcome
Reduction in Ovary volume as assessed by ultrasound
Time frame: 12 weeks
volume in cubic cms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Background: PubMed 15788499Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
- Background: PubMed 14740344Schroder AK, Tauchert S, Ortmann O, Diedrich K, Weiss JM. [Insulin resistance in polycystic ovary syndrome]. Wien Klin Wochenschr. 2003 Dec 15;115(23):812-21. doi: 10.1007/BF03041041. German.
- Background: PubMed 24250624Hassanzadeh Bashtian M, Emami SA, Mousavifar N, Esmaily HA, Mahmoudi M, Mohammad Poor AH. Evaluation of Fenugreek (Trigonella foenum-graceum L.), Effects Seeds Extract on Insulin Resistance in Women with Polycystic Ovarian Syndrome. Iran J Pharm Res. 2013 Spring;12(2):475-81.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Amrita Sarkari Jaipuriar, MS principal investigator
Garg Hospital,Goalghar .Gorakhpur,UP,India
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenugreek seeds extract 500 mg in people with Poly Cystic Ovary Syndrome, run by Chemical Resources.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Ovary volume as assessed by ultrasound (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789488, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.