PCOSPhase 2NCT04867252
Effects of Combined Resveratrol and Myo-inositol on Altered Metabolic, Endocrine Parameters and Perceived Stress in Patients With Polycystic Ovarian Syndrome
A Phase 2 study testing Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day) and Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day) in people with PCOS, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of combined Resveratrol and Myo-Inositol on altered metabolic, endocrine parameters and perceived stress response in patients with Polycystic Ovary Syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day) and Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 3 May 2021to 3 Aug 2021
- Phase
- Phase 2
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Treatment naive PCOS women having age from 14-45 years with scanty or no menstruation, hirsutism and elevated serum androgen levels, will be diagnosed on the basis of AES (Androgen access society) guidelines 2006 according to which when two of the following criteria are present patient will be said to have the syndrome
- Hirsutism or hyperandrogenism
- Oligo or an-ovulation and or polycystic ovaries
Who cannot join
- Women with previous history of Cushing syndrome
- Thyroid disorders
- Hyperprolactinemia
- Ovarian tumors
- Congenital adrenal hyperplasia androgen-producing tumors,
- History of seizures
Show all 9Show fewer
- Patients on warfarin, Coumadin and Sintrom because of drug interaction with acetyl-L-Carnitine,
- Pregnancy or using contraceptive medications,
- Patients on hormonal therapy that alters the biochemical or hormonal profile
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gynecology and Obstetric, Hayatabad Medical Complex
Peshawar, Khyber Pukhtunkhwa, 25000
About this study
The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of combined Resveratrol and Myo-Inositol on altered metabolic, endocrine parameters and perceived stress response in patients with Polycystic Ovary Syndrome (PCOS). Women diagnosed with PCOS, using criteria proposed in November 2015, by the American Association of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE), and Androgen Excess and PCOS Society (AES) for PCOS should include two of the following three criteria: chronic an ovulation, hyperandrogenism (clinical/biologic), and polycystic ovaries. The investigators propose that PCOS women may have altered metabolic, endocrine levels and increased perceived stress response and combination therapy may have beneficial influences on these parameters in women diagnosed with PCOS.
Read the detailed description
Polycystic ovarian syndrome (PCOS) is extremely prevalent and considered to be the most common heterogeneous endocrine disorder in reproductive age women. This affects up to 10-15% of women in reproductive age. PCOS is a multifaceted health issue characterized by chronic anovulation with excess ovarian activity, hyperandrogenism and polycystic ovaries. The most disappointment for women with PCOS is pregnancy loss.
This endocrine disorder has some long term effects including cardiovascular diseases, metabolic and sexual dysfunction, depression and anxiety that effects the overall quality of life. Women with PCOS have a greater risk of developing hyperinsulinemia and insulin resistance and this explains the substantially increased prevalence of glucose intolerance in PCOS. Recent long-term follow up studies of the syndrome have shown that dyslipidemia and hyperlipidemia is a very common metabolic abnormality in these women. The key pathophysiology of PCOS is Insulin resistance, thus dyslipidemia in women may be constant with those found in an insulin resistant state. Low adiponectin levels in PCOS have been largely associated with obesity which is common among these patients. Serum adiponectin levels are associated with PCOS independently and are only explained by IR partly. An independent biomarker, adiponectin can be used for diagnosing PCOS in young and lean women or women with a family history of PCOS.
Resveratrol (3,5,4-trihydroxy-trans-stilbene) belongs to polyphenols stilbene group found in grapes, peanuts, red wine and many medicinal plants. Studies have shown that patients treated with resveratrol have shown improve glucose homeostasis and reverse insulin resistance. Treatment with resveratrol improved the elevated number of atretic and secondary follicles and the decreased number of Graafian follicles in the PCOS group, which indicates the effect of the treatments on the maintenance of folliculogenesis. It has been reported to interact with multiple cell targets, but its major effects are brought about by the activation of SIRT1 (silent information regulator1).The SIRT1 is expressed in oocytes and human granulosa nuclei cells at multiple developmental stages of the follicles. It is also responsible for suppressing inflammation. Moreover, SIRT1 is also involved in protecting the oocytes from age dependent insufficiencies through oxidative stress.
Myo-Inositol is a carbocyclic sugar, belongs to Inositol group and is an important component of structural lipids. Inositol's or its phosphates and the associated lipids are found in different fruits specially cantaloupe and oranges. It is the precursor of inositol triphosphate, acting as an intracellular second messenger and regulating a number of hormones such as thyroid-stimulating hormone, follicle-stimulating hormone (FSH) and insulin. One of the insulin-sensitizing compounds, Myo-Inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. Inositol's improve the metabolic and endocrine parameters in young, overweight PCOS patients and regulate the monthly cycles. Treatment with inositol's in obese PCOS patients is also effective in reducing BMI. The decrease in BMI is without any lifestyle modification.
PCOS is a systemic condition, an endocrinopathy whose etiology is still not understood, correct treatment regimens of PCOS will not only improve menstrual cycles of the patients but will also improve the metabolic or endocrinological parameters. PCOS sufferers are also known to have increased levels of perceived stress which will be considered in the study. Very little evidence is available on combination therapy for treatment of PCOS patients. In this study our goal will be to come up with a better treatment option to treat the disease effectively.
Study Objectives:
To investigate the effects of combined Resveratrol and Myo-Inositol treatment after 3 months on metabolic, endocrine alterations and perceived stress response in patients with PCOS.
- Conditions
- PCOS
- Being tested
- Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day), Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day)
- Keywords
- PCOS, Resveratrol and Myoinositol
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day)Drug
51 Patients with PCOS receiving Resveratrol and Myoinositol 1000mg and 1000mg BD daily respectively
Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day)Drug
Also called Zolid Plus
51 Patients with PCOS receiving Metformin and Pioglitazone 500 mg and 15 mg BD daily respectively
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Group | Active comparator | ARM 1: Resveratrol (1000mg Twice a day) Myoinositol (1000mg Twice a day) Receives: Drug: Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day) |
| Standard Therapy Group | Other | ARM 2:Metformin 500mg (Twice a day) Pioglitazone (15mg Twice a day) Receives: Drug: Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance
PCOS associated insulin resistance and hyperinsulinemia through HOMA-IR
Measured: 3 months
Hypoadiponectinemia
PCOS associated Hypoadiponectinemia. Measurement of adiponectin levels through human adiponectin enzyme-linked immunosorbent assay (ELISA ) kit and the values of serum adiponectin reported in microgram/mL.
Measured: 3 months
Ovary volume
Polycystic ovaries volume measurement by abdominopelvic ultrasound
Measured: 3 months
Stress response
Perceived stress response and profile of mood stress by structured questionnaire
Measured: 3 months
Secondary outcomes (3)
Body fat analysis
Body fats measurement through measurement scale
Measured: 3 months
Hirsutism
Hirsutism grading scale, Ferriman Gallwey Score is used to evaluate hirsutism. A score of 1 to 4 is given for nine areas of the bod including upper lip, chin, chest, upper abdomen, lower abdomen, arms, thighs, upper back and lower back. A total score less than 8 is considered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.
Measured: 3 months
Abnormal menstruation patterns both oligomenorrhea or amenorrhea attributed to chronic anovulation
Oligomenorrhea evaluated by menstrual bleeding that has occurred at intervals of 35 days to 6 months, with < 9 menstrual periods per year and secondary amenorrhea assessed by absence of menstruation for 6 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start3 May 2021
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsin Shah, Khyber Medical University Peshawar
- Investigators
- Mohsin Shah, PhD, Principal investigator, Department of Physiology, Khyber Medical University, Peshawar Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867252
- Sponsor's protocol ID
- ASRB001226/EC/IBMS
- Status last verified
- Sep 2021
- First submitted
- 24 Apr 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rocha AL, Oliveira FR, Azevedo RC, Silva VA, Peres TM, Candido AL, Gomes KB, Reis FM. Recent advances in the understanding and management of polycystic ovary syndrome. F1000Res. 2019 Apr 26;8:F1000 Faculty Rev-565. doi: 10.12688/f1000research.15318.1. eCollection 2019.
PubMed 31069057Monastra G, Unfer V, Harrath AH, Bizzarri M. Combining treatment with myo-inositol and D-chiro-inositol (40:1) is effective in restoring ovary function and metabolic balance in PCOS patients. Gynecol Endocrinol. 2017 Jan;33(1):1-9. doi: 10.1080/09513590.2016.1247797. Epub 2016 Nov 29.
PubMed 27898267Sirmans SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol. 2013 Dec 18;6:1-13. doi: 10.2147/CLEP.S37559.
PubMed 24379699Carmina E, Lobo RA. Polycystic ovary syndrome (PCOS): arguably the most common endocrinopathy is associated with significant morbidity in women. J Clin Endocrinol Metab. 1999 Jun;84(6):1897-9. doi: 10.1210/jcem.84.6.5803. No abstract available.
PubMed 10372683Bajuk Studen K, Pfeifer M. Cardiometabolic risk in polycystic ovary syndrome. Endocr Connect. 2018 Jul;7(7):R238-R251. doi: 10.1530/EC-18-0129. Epub 2018 May 29.
PubMed 29844207Dunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. doi: 10.1210/edrv.18.6.0318.
PubMed 9408743Kim JJ, Choi YM. Dyslipidemia in women with polycystic ovary syndrome. Obstet Gynecol Sci. 2013 May;56(3):137-42. doi: 10.5468/ogs.2013.56.3.137. Epub 2013 May 16.
PubMed 24327994Mirza SS, Shafique K, Shaikh AR, Khan NA, Anwar Qureshi M. Association between circulating adiponectin levels and polycystic ovarian syndrome. J Ovarian Res. 2014 Feb 7;7:18. doi: 10.1186/1757-2215-7-18.
PubMed 24502610Salehi B, Mishra AP, Nigam M, Sener B, Kilic M, Sharifi-Rad M, Fokou PVT, Martins N, Sharifi-Rad J. Resveratrol: A Double-Edged Sword in Health Benefits. Biomedicines. 2018 Sep 9;6(3):91. doi: 10.3390/biomedicines6030091.
PubMed 30205595Hassan S, Shah M, Malik MO, Ehtesham E, Habib SH, Rauf B. Treatment with combined resveratrol and myoinositol ameliorates endocrine, metabolic alterations and perceived stress response in women with PCOS: a double-blind randomized clinical trial. Endocrine. 2023 Jan;79(1):208-220. doi: 10.1007/s12020-022-03198-2. Epub 2022 Sep 28.
PubMed 36169918
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Resveratrol and Myo-inositol on Altered Metabolic, Endocrine Parameters and Perceived Stress in Patients With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT04867252
- Acronym / sponsor ID
- ASRB001226/EC/IBMS
- Conditions
- PCOS
- Keywords
- PCOS, Resveratrol and Myoinositol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 30 Apr 2021 (actual)
- 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.
The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of combined Resveratrol and Myo-Inositol on altered metabolic, endocrine parameters and perceived stress response in patients with Polycystic Ovary Syndrome (PCOS). Women diagnosed with PCOS, using criteria proposed in November 2015, by the American Association of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE), and Androgen Excess and PCOS Society (AES) for PCOS should include two of the following three criteria: chronic an ovulation, hyperandrogenism (clinical/biologic), and polycystic ovaries. The investigators propose that PCOS women may have altered metabolic, endocrine levels and increased perceived stress response and combination therapy may have beneficial influences on these parameters in women diagnosed with PCOS.
Detailed description
Polycystic ovarian syndrome (PCOS) is extremely prevalent and considered to be the most common heterogeneous endocrine disorder in reproductive age women. This affects up to 10-15% of women in reproductive age. PCOS is a multifaceted health issue characterized by chronic anovulation with excess ovarian activity, hyperandrogenism and polycystic ovaries. The most disappointment for women with PCOS is pregnancy loss.
This endocrine disorder has some long term effects including cardiovascular diseases, metabolic and sexual dysfunction, depression and anxiety that effects the overall quality of life. Women with PCOS have a greater risk of developing hyperinsulinemia and insulin resistance and this explains the substantially increased prevalence of glucose intolerance in PCOS. Recent long-term follow up studies of the syndrome have shown that dyslipidemia and hyperlipidemia is a very common metabolic abnormality in these women. The key pathophysiology of PCOS is Insulin resistance, thus dyslipidemia in women may be constant with those found in an insulin resistant state. Low adiponectin levels in PCOS have been largely associated with obesity which is common among these patients. Serum adiponectin levels are associated with PCOS independently and are only explained by IR partly. An independent biomarker, adiponectin can be used for diagnosing PCOS in young and lean women or women with a family history of PCOS.
Resveratrol (3,5,4-trihydroxy-trans-stilbene) belongs to polyphenols stilbene group found in grapes, peanuts, red wine and many medicinal plants. Studies have shown that patients treated with resveratrol have shown improve glucose homeostasis and reverse insulin resistance. Treatment with resveratrol improved the elevated number of atretic and secondary follicles and the decreased number of Graafian follicles in the PCOS group, which indicates the effect of the treatments on the maintenance of folliculogenesis. It has been reported to interact with multiple cell targets, but its major effects are brought about by the activation of SIRT1 (silent information regulator1).The SIRT1 is expressed in oocytes and human granulosa nuclei cells at multiple developmental stages of the follicles. It is also responsible for suppressing inflammation. Moreover, SIRT1 is also involved in protecting the oocytes from age dependent insufficiencies through oxidative stress.
Myo-Inositol is a carbocyclic sugar, belongs to Inositol group and is an important component of structural lipids. Inositol's or its phosphates and the associated lipids are found in different fruits specially cantaloupe and oranges. It is the precursor of inositol triphosphate, acting as an intracellular second messenger and regulating a number of hormones such as thyroid-stimulating hormone, follicle-stimulating hormone (FSH) and insulin. One of the insulin-sensitizing compounds, Myo-Inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. Inositol's improve the metabolic and endocrine parameters in young, overweight PCOS patients and regulate the monthly cycles. Treatment with inositol's in obese PCOS patients is also effective in reducing BMI. The decrease in BMI is without any lifestyle modification.
PCOS is a systemic condition, an endocrinopathy whose etiology is still not understood, correct treatment regimens of PCOS will not only improve menstrual cycles of the patients but will also improve the metabolic or endocrinological parameters. PCOS sufferers are also known to have increased levels of perceived stress which will be considered in the study. Very little evidence is available on combination therapy for treatment of PCOS patients. In this study our goal will be to come up with a better treatment option to treat the disease effectively.
Study Objectives:
To investigate the effects of combined Resveratrol and Myo-Inositol treatment after 3 months on metabolic, endocrine alterations and perceived stress response in patients with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Active comparator | Drug: Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day)ARM 1: Resveratrol (1000mg Twice a day) Myoinositol (1000mg Twice a day) |
| Standard Therapy Group | Other | Drug: Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day)ARM 2:Metformin 500mg (Twice a day) Pioglitazone (15mg Twice a day) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Treatment naive PCOS women having age from 14-45 years with scanty or no menstruation, hirsutism and elevated serum androgen levels, will be diagnosed on the basis of AES (Androgen access society) guidelines 2006 according to which when two of the following criteria are present patient will be said to have the syndrome
- Hirsutism or hyperandrogenism
- Oligo or an-ovulation and or polycystic ovaries
Key exclusion criteria (9 listed)
- Women with previous history of Cushing syndrome
- Thyroid disorders
- Hyperprolactinemia
- Ovarian tumors
- Congenital adrenal hyperplasia androgen-producing tumors,
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 |
|---|---|---|
| Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day)51 Patients with PCOS receiving Resveratrol and Myoinositol 1000mg and 1000mg BD daily respectively | Drug | Combination Therapy Group |
| Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day)Also: Zolid Plus51 Patients with PCOS receiving Metformin and Pioglitazone 500 mg and 15 mg BD daily respectively | Drug | Standard Therapy Group |
Primary outcome
Insulin Resistance
Time frame: 3 months
PCOS associated insulin resistance and hyperinsulinemia through HOMA-IR
Hypoadiponectinemia
Time frame: 3 months
PCOS associated Hypoadiponectinemia. Measurement of adiponectin levels through human adiponectin enzyme-linked immunosorbent assay (ELISA ) kit and the values of serum adiponectin reported in microgram/mL.
Ovary volume
Time frame: 3 months
Polycystic ovaries volume measurement by abdominopelvic ultrasound
Stress response
Time frame: 3 months
Perceived stress response and profile of mood stress by structured questionnaire
3 secondary outcomes
Body fat analysis
Time frame: 3 months
Hirsutism
Time frame: 3 months
Abnormal menstruation patterns both oligomenorrhea or amenorrhea attributed to chronic anovulation
Time frame: 3 months
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 13 Sep 2021.
- Background: PubMed 31069057Rocha AL, Oliveira FR, Azevedo RC, Silva VA, Peres TM, Candido AL, Gomes KB, Reis FM. Recent advances in the understanding and management of polycystic ovary syndrome. F1000Res. 2019 Apr 26;8:F1000 Faculty Rev-565. doi: 10.12688/f1000research.15318.1. eCollection 2019.
- Background: PubMed 27898267Monastra G, Unfer V, Harrath AH, Bizzarri M. Combining treatment with myo-inositol and D-chiro-inositol (40:1) is effective in restoring ovary function and metabolic balance in PCOS patients. Gynecol Endocrinol. 2017 Jan;33(1):1-9. doi: 10.1080/09513590.2016.1247797. Epub 2016 Nov 29.
- Background: PubMed 24379699Sirmans SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol. 2013 Dec 18;6:1-13. doi: 10.2147/CLEP.S37559.
- Background: PubMed 10372683Carmina E, Lobo RA. Polycystic ovary syndrome (PCOS): arguably the most common endocrinopathy is associated with significant morbidity in women. J Clin Endocrinol Metab. 1999 Jun;84(6):1897-9. doi: 10.1210/jcem.84.6.5803. No abstract available.
- Background: PubMed 29844207Bajuk Studen K, Pfeifer M. Cardiometabolic risk in polycystic ovary syndrome. Endocr Connect. 2018 Jul;7(7):R238-R251. doi: 10.1530/EC-18-0129. Epub 2018 May 29.
- Background: PubMed 9408743Dunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. doi: 10.1210/edrv.18.6.0318.
- Background: PubMed 24327994Kim JJ, Choi YM. Dyslipidemia in women with polycystic ovary syndrome. Obstet Gynecol Sci. 2013 May;56(3):137-42. doi: 10.5468/ogs.2013.56.3.137. Epub 2013 May 16.
- Background: PubMed 24502610Mirza SS, Shafique K, Shaikh AR, Khan NA, Anwar Qureshi M. Association between circulating adiponectin levels and polycystic ovarian syndrome. J Ovarian Res. 2014 Feb 7;7:18. doi: 10.1186/1757-2215-7-18.
- Background: PubMed 30205595Salehi B, Mishra AP, Nigam M, Sener B, Kilic M, Sharifi-Rad M, Fokou PVT, Martins N, Sharifi-Rad J. Resveratrol: A Double-Edged Sword in Health Benefits. Biomedicines. 2018 Sep 9;6(3):91. doi: 10.3390/biomedicines6030091.
- Derived from this study: PubMed 36169918Hassan S, Shah M, Malik MO, Ehtesham E, Habib SH, Rauf B. Treatment with combined resveratrol and myoinositol ameliorates endocrine, metabolic alterations and perceived stress response in women with PCOS: a double-blind randomized clinical trial. Endocrine. 2023 Jan;79(1):208-220. doi: 10.1007/s12020-022-03198-2. Epub 2022 Sep 28.
- 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.
Mohsin Shah, PhD principal investigator
Department of Physiology, Khyber Medical University, Peshawar Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day) and Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day) in people with PCOS, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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 3 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 13 Sep 2021. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Insulin Resistance (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT04867252, which also lists 10 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 13 Sep 2021.