PCOSNCT02703064
Furocyst - Poly Cystic Ovary Syndrome Study
A study testing Furocyst in people with PCOS, run by Chemical Resources at 1 site in India.
Trial summary
Poly cystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, affecting approximately 5%-10% of all females worldwide . PCOS is a hormonal disorder that involves multiple organ systems within the body. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- Furocyst
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteIndia
- Study dates
- 26 Mar 2015to Jul 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women between 18-45 years of age and BMI less than 42
- Diagnosed with PCOS by Rottadom Criteria
- Adequate hepatic, renal, Cardiac and hematological functions.
- Patients willing to Participate and give informed consent in writing as well as in audio-visual form for the study.
- Stable weight for last two months (Change of weight<3kg)
Who cannot join
- Male
- Post menopausal women
- Women with hysterectomy
- Hyperprolactinemia
- Patients with congenital adrenal hyperplasia
- Patients suffering from Cushing's syndrome
Show all 14Show fewer
- Acute or chronic Medical illness including Hepatic, Cardiac or renal insufficiency, COPD,Gastrointestinal Disorders
- Uncontrolled Hypertensive or known Diabetics on drugs
- Use of oral contraceptives or HRT for last three months
- Smoking or drug addicts or with psychiatric illness
- Patients diagnosed with androgen secreting tumors.
- 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)
- Pregnant or lactating mothers
Trial locations and contacts
1 site in 1 country.
India1 site
Dept of Obs & Gynae, King George's Medical University, Lucknow, UP, India
Lucknow, Uttar Pradesh, 226003
About this study
Official title: To Study the Efficacy and Safety of Furocyst in Poly Cystic Ovary Syndrome Patients (PCOS)
Poly cystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, affecting approximately 5%-10% of all females worldwide . PCOS is a hormonal disorder that involves multiple organ systems within the body. Its cardinal features are Hyperandrogenism and polycystic ovary (PCO) morphology. Women with PCOS may complains about irregular menstrual periods or heavy menstrual bleeding, infertility, excessive growth of coarse facial and body hair, obesity, oiliness of the skin, seborrhea, and cystic acne.
Read the detailed description
The symptoms of PCOS are anovulation, resulting in irregular menstruation (amenorrhea and oligomenorrhea) ovulation-related infertility, and polycystic ovaries, often associated with obesity, Type 2 diabetes, and high cholesterol levels. The level of serum insulin and insulin resistance are higher in women with PCOS (Hyperinsulinemia).Insulin resistance, defined as the decreased insulin mediated glucose utilization it is more common in women with PCOS up to 50 % in both obese and non obese women . It has also been recognized that some women with this syndrome will have PCO without clinical evidence of androgen excess, but will display evidence of ovarian dysfunction .
It is believed to be that, the Hyperinsulinemia of PCOS stimulates the androgens production and increase the activity by decreasing the sex hormone binding globulin (SHBG) thus increasing the free active testosterone level and by the activating the cytochrome P 450 C 17 alpha enzymatic system that controls androgens production.
The diagnosis of PCOS is based on Hyperandrogenism and chronic anovulation in the absence of specific pituitary or adrenal disease , and have disrupted ovulatory function with chronic oligomenorrhea (cycle length > 35 day) or amenorrhea (cycle length > 12 week) and typical appearance of polycystic ovaries by ultrasound according to the criteria of the Rotterdam consensus meeting 2003 for diagnosis of PCOS. The different diagnostic tests needed to adequately assess for the possibility of PCOS e.g. Pregnancy test, TSH level (for Hyperthyroidism), Prolactin test (for Hyperprolactinemia), Total testosterone (for ovarian tumor) and some tests forevaluating the insulin resistance syndrome in women: Waist circumference (>88 cm), Triglycerides (>150 mg/dL), HDL Cholesterol (<50 mg/dL), Blood pressure (>130/85) and Fasting glucose (>110 mg/dL). Fasting glucose- to- insulin ratio and 2 hour oral glucose tolerance test (2h- OGTT 140 - 199 mg/dL) may be better predictor of insulin resistance .
The management of the PCOS is symptoms specific e.g.
- Oral contraceptives, periodic progesterone withdrawal for the control of irregular menstruation.
- Oral contraceptives, Metformin and anti-androgens (Spironolactone) for the Hirsutism.
- Clomiphene citrate, Metformin and thiazolidinediones for infertility. A recent study shown that, the combination of Metformin plus Clomiphene citrate should be considered as the First line treatment for infertile women with PCOS .
- Metformin and lifestyle modification for the insulin resistance and diabetes mellitus.
All these management options are only for "acute" not for "chronic". The long-term management approach for the PCOS is needed which will be based on management of most affecting factor insulin resistance.
- Conditions
- PCOS
- Being tested
- Furocyst
- Keywords
- Furocyst, PCOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurocystDietary supplement
Also called Standardized fenugreek extract
Furocyst caps BD
| Study group | Role | What they receive |
|---|---|---|
| Furocyst | Experimental | Furocyst 500mg capsule, BD Receives: Dietary Supplement: Furocyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Overian volume & Number of overian Cysts
Measured: 12 weeks
Secondary outcomes (1)
Restoration of normal menstrual cycle
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 posted9 Mar 2016 (estimated)
- Study start26 Mar 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open level
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemical Resources
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Pushpalata Sankhwar, M.S., Principal investigator, Dept of Obs & Gynae,King George's Medical University, Lucknow, UP, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703064
- Sponsor's protocol ID
- Protocol No. CR-PCOS/1-15
- Status last verified
- Aug 2016
- First submitted
- 29 Sep 2015
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Polson DW, Adams J, Wadsworth J, Franks S. Polycystic ovaries--a common finding in normal women. Lancet. 1988 Apr 16;1(8590):870-2. doi: 10.1016/s0140-6736(88)91612-1.
PubMed 2895373
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Efficacy and Safety of Furocyst in Poly Cystic Ovary Syndrome Patients (PCOS)
- ClinicalTrials.gov ID
- NCT02703064
- Acronym / sponsor ID
- Protocol No. CR-PCOS/1-15
- Conditions
- PCOS
- Keywords
- Furocyst, PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Chemical ResourcesIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Mar 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 the most common endocrine disorder in women of reproductive age, affecting approximately 5%-10% of all females worldwide . PCOS is a hormonal disorder that involves multiple organ systems within the body. Its cardinal features are Hyperandrogenism and polycystic ovary (PCO) morphology. Women with PCOS may complains about irregular menstrual periods or heavy menstrual bleeding, infertility, excessive growth of coarse facial and body hair, obesity, oiliness of the skin, seborrhea, and cystic acne.
Detailed description
The symptoms of PCOS are anovulation, resulting in irregular menstruation (amenorrhea and oligomenorrhea) ovulation-related infertility, and polycystic ovaries, often associated with obesity, Type 2 diabetes, and high cholesterol levels. The level of serum insulin and insulin resistance are higher in women with PCOS (Hyperinsulinemia).Insulin resistance, defined as the decreased insulin mediated glucose utilization it is more common in women with PCOS up to 50 % in both obese and non obese women . It has also been recognized that some women with this syndrome will have PCO without clinical evidence of androgen excess, but will display evidence of ovarian dysfunction .
It is believed to be that, the Hyperinsulinemia of PCOS stimulates the androgens production and increase the activity by decreasing the sex hormone binding globulin (SHBG) thus increasing the free active testosterone level and by the activating the cytochrome P 450 C 17 alpha enzymatic system that controls androgens production.
The diagnosis of PCOS is based on Hyperandrogenism and chronic anovulation in the absence of specific pituitary or adrenal disease , and have disrupted ovulatory function with chronic oligomenorrhea (cycle length > 35 day) or amenorrhea (cycle length > 12 week) and typical appearance of polycystic ovaries by ultrasound according to the criteria of the Rotterdam consensus meeting 2003 for diagnosis of PCOS. The different diagnostic tests needed to adequately assess for the possibility of PCOS e.g. Pregnancy test, TSH level (for Hyperthyroidism), Prolactin test (for Hyperprolactinemia), Total testosterone (for ovarian tumor) and some tests forevaluating the insulin resistance syndrome in women: Waist circumference (>88 cm), Triglycerides (>150 mg/dL), HDL Cholesterol (<50 mg/dL), Blood pressure (>130/85) and Fasting glucose (>110 mg/dL). Fasting glucose- to- insulin ratio and 2 hour oral glucose tolerance test (2h- OGTT 140 - 199 mg/dL) may be better predictor of insulin resistance .
The management of the PCOS is symptoms specific e.g.
- Oral contraceptives, periodic progesterone withdrawal for the control of irregular menstruation.
- Oral contraceptives, Metformin and anti-androgens (Spironolactone) for the Hirsutism.
- Clomiphene citrate, Metformin and thiazolidinediones for infertility. A recent study shown that, the combination of Metformin plus Clomiphene citrate should be considered as the First line treatment for infertile women with PCOS .
- Metformin and lifestyle modification for the insulin resistance and diabetes mellitus.
All these management options are only for "acute" not for "chronic". The long-term management approach for the PCOS is needed which will be based on management of most affecting factor insulin resistance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open level
| Arm | Type | Receives |
|---|---|---|
| Furocyst | Experimental | Dietary Supplement: FurocystFurocyst 500mg capsule, BD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premenopausal women between 18-45 years of age and BMI less than 42
- Diagnosed with PCOS by Rottadom Criteria
- Adequate hepatic, renal, Cardiac and hematological functions.
- Patients willing to Participate and give informed consent in writing as well as in audio-visual form for the study.
- Stable weight for last two months (Change of weight<3kg)
Key exclusion criteria (14 listed)
- Male
- Post menopausal women
- Women with hysterectomy
- Hyperprolactinemia
- Patients with congenital adrenal hyperplasia
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 |
|---|---|---|
| FurocystAlso: Standardized fenugreek extractFurocyst caps BD | Dietary supplement | Furocyst |
Primary outcome
Reduction in Overian volume & Number of overian Cysts
Time frame: 12 weeks
1 secondary outcome
Restoration of normal menstrual cycle
Time frame: 12 weeks
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 15 Sep 2017.
- Background: PubMed 2895373Polson DW, Adams J, Wadsworth J, Franks S. Polycystic ovaries--a common finding in normal women. Lancet. 1988 Apr 16;1(8590):870-2. doi: 10.1016/s0140-6736(88)91612-1.
- Individual participant dataSharing planned: No
Related trials for PCOS
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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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. Pushpalata Sankhwar, M.S. principal investigator
Dept of Obs & Gynae,King George's Medical University, Lucknow, UP, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furocyst in people with PCOS, run by Chemical Resources at 1 site in India.
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 5 inclusion and 14 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Overian volume & Number of overian Cysts (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 NCT02703064, which also lists 1 linked publication.
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 15 Sep 2017.