Polycystic Ovary SyndromeNCT04009603
Comparison of Probiotics, Metformin & Their Combination Therapy in the Treatment of PCOS
A study testing Probiotic Agent and Metformin in people with Polycystic Ovary Syndrome, run by Ziauddin University at 1 site in Pakistan.
Trial summary
Polycystic ovary syndrome (PCOS) is a common gynecological state worldwide characterized by numerous small cysts in the ovaries mainly due to the imbalance of endocrine hormones in premenopausal women. Metformin is long being used for different symptoms of PCOS along with other medication. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Probiotic Agent and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Dec 2018to 28 Jan 2020
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The patient will be included according to the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine sponsored a PCOS consensus criterion which says the presence of any two of the following three features must be present for the patient to be diagnosed as a case of PCOS:
- Oligomenorrhea and/or amenorrhea (Oligomenorrhea>45 days or <8 cycles per year and amenorrhea >3 months in women with previous periodic menses) for a period of 6 months
- Clinical and/or biochemical hyperandrogenemia, the presence of acne, hirsutism (FG score>8), and alopecia
- Polycystic ovaries on sonography (>12 follicles in one or both ovaries, 2-9 mm in diameter and/or increased ovarian volume >10 mL).
Who cannot join
- History of chronic diseases
- Allergic to probiotic or metformin
- Current or previous (within the last 6 months) use of chemotherapy or other drugs.
- History of smoking
- Individuals with autoimmune disease
- Individuals with autoimmune disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Probiotics, Metformin and Their Combination Therapy in Improving Symptoms of Polycystic Ovarian Syndrome.̎- A Randomized Clinical Trial
Polycystic ovary syndrome (PCOS) is a common gynecological state worldwide characterized by numerous small cysts in the ovaries mainly due to the imbalance of endocrine hormones in premenopausal women. Metformin is long being used for different symptoms of PCOS along with other medication. This study involves the assessment of different parameters of PCOS.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a hormonal disorder affecting the women of reproductive age. It is a heterogeneous health condition that affects 1 in every 10 women of childbearing age. Women of all races and ethnicities are at risk for PCOS, but risk increases multiple folds if the BMI is greater than 30kg/m2. The common signs and symptoms, the women usually represent with are menstrual irregularities, hyperandrogenemia and multiple cysts in ovaries. The exact cause of PCOS is still unknown but genetic and obesity is considered to be the most common cause.
Metformin has been considered as the first line agent for the treatment of non-insulin dependent diabetes mellitus and up till now it has been used as a first line drug for PCOS. Despite its beneficial effects in PCOS it has several adverse effects. Moreover, patients usually seek two or more drugs along with metformin to relieve maximum symptoms of PCOS like for ovulation clomiphene citrate must be given etc. So there is a need of novel and comprehensive agent that can prove to be effective in improving maximum symptoms of this disease. Probiotics have received renewed attention in the 21st century through research studies. World Health Organization's (WHO) 2001 defines probiotics as live micro-organisms that, when administered in adequate amounts, confer a health benefit on the host. In recent year it has shown tremendous promising effect in treatment of different diseases like diarrhea, gingivitis and obesity etc with negligible side effects.
In this context the investigators are going to evaluate and compare the effects of probiotics, metformin and their combination therapy in treatment of various symptoms of PCOS.60 newly diagnosed PCOS patient will be assigned in the open label randomized clinical trial. As mentioned above patients will be divided into three groups with 20 patients each. In group 1, the dosage of metformin will be 500mg B.D and 2 gm of probiotic sachet O.D, the second group will be given metformin 500mg B.D. and the third group will be 2mg of probiotics B.D. It would be a follow-up study that would be conducted in Gynecology OPD of Tertiary Care Hospital
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Probiotic Agent, Metformin
- 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.
Probiotic AgentDrug
Also called Ecotec
Probiotics are live microorganisms, which when administered in adequate amounts confer a health benefit effects on the host.
Many clinical trials have been done on probiotic which show its use as a single or as an adjuvant drug therapy for various diseases with no or rare side effects. It is now frequently used agent for various diseases.
Apart from this many studies have been published related to effects of probiotics on PCOS, which shows effectiveness of probiotics when used for 8 to 12 weeks with no adverse effects observed by these micro-organisms but none of the study have compare it with standarad drug
MetforminDrug
Also called glucophage
Metformin, an insulin sensitizer, is an oral biguanide that is most commonly prescribed for the management of type II diabetes mellitus and various symptoms of PCOS. It is derived from the extract of Galega officinalis.
It remediates hyperglycemia through activation of AMPK which stimulates glucose uptake and its consumption; promote fatty acid oxidation along with suppression of hepatic glucose production. It is also involved in increase GLUT4 translocation in the muscle and fat leading to decrease hepatic lipid synthesis. Moreover, It is also reported that it decreases gut absorption of glucose by increasing the glucagon-like peptide-1 (GLP-1) in this way, it reduces the insulin requirement too.All of these actions of metformin decrease insulin resistance and thus improve the state of hyperinsulinemia associated with diabetes and PCOS
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Group no 1(26 patients) Metformin tablets at a dose of 500mg BD for 12 weeks Receives: Drug: Metformin |
| Probiotic | Experimental | Group no 2(26 patients): will be given probiotics alone at a dose of 180mg B.D for 12 weeks Receives: Drug: Probiotic Agent |
| Metformin and Probiotic | Experimental | Group no 3(26 patients): will be given metformin 500mg B.D and probiotics 180mgram O.D. for 12 week Receives: Drug: Probiotic Agent; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameter:
Fasting serum glucose:
The blood sample for FBS will be collected on day 2 or 3 of the menses. The blood samples will be taken before the start and at the end of the treatment.
fasting glucose 80-100 mg/dl
Measured: 12 weeks
Hormonal parameter:
Androgens:
The concentration of these hormones will be evaluated at the baseline and at the end of treatment usually in the morning between 8:00 am to 9:00 am after overnight fasting
Serum testosterone:15 and 70 ng/dL
Measured: 12 weeks
Change in cyst size on Ultrasonography
Ovary cyst size:
The size of the cyst will be measured before the start and at the end of the study, considering 12 or more follicles in at least 1 ovary or both-measuring 2-9 mm in diameter-or a total ovarian volume greater than 10 cm3
Measured: 12 weeks
Luteinizing Hormone
LH
The concentration of this endocrine hormones is determined will be obtained on day 2 or 3 of the normal menstruation cycle and at any time in women with amenorrhea.
LH: 1.9 to 12.5 IU/L
Measured: 12 weeks
INSULIN LEVELS
Fasting serum insulin:
The sample is collected after fasting of 12 to 14 hours will be measured before and after intervention
fasting insulin < 25 mIU/L
Measured: 12 weeks
Lipid
Lipid profile:
- Total cholesterol
- LDL
- HDL
- Triglyceride
The serum lipid concentrations will be evaluated spectrophotometrically by means of commercial kits at baseline and at the end of the study
Total cholesterol < 200
Triglyceride: <150 mg/dl
HDL: > 60mg/ dl
LDL: < 130mg /dl
Measured: 12 weeks
Follicle-stimulating hormone
The concentration of this endocrine hormones is determined will be obtained on day 2 or 3 of the normal menstruation cycle and at any time in women with amenorrhea.
LH: 4.5 to 21.5 IU/L
Measured: 12 weeks
LH and FSH ratio
LH:FSH The serum levels of FSH:LH ratio will be assessed before the start and at the end of the management on day 2 or 3 of the normal menses and at any time in women with amenorrhea.
1.5:1
Measured: 12 weeks
Secondary outcomes (4)
Change in Physical symptoms in PCOS
Weight:
The body weight of the females will be recorded at baseline and at the end of the treatment with the help of weighing machine in kg.
Measured: 12 weeks
Menstruration
Menstrurational irregularities:
All study participants will be asked about menstruation irregularities at the time of enrollment.They will also be enquired about for long they have their cycles have been disturbed.They will be asked to maintain their cycle dates as well.
Measured: 12 weeks
Hirsutism
Hirsutism:
History and physical examination, including pelvic examination at the start and at the end of treatment using the Ferriman-Gallwey scale for hirsutism.
Measured: 12 week
Acne
Acne:
Acne score will be taken at baseline and at the end of the treatment through the Global Acne grading system.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Dec 2018
- Primary completion30 Jun 2019
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polycystic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Urooj Zafar, Ziauddin University
- Investigators
- Dr.Urooj Zafar, M.Phil, Principal investigator, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009603
- Sponsor's protocol ID
- 651118UZPHA
- Status last verified
- Jul 2020
- First submitted
- 28 Mar 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmadi S, Jamilian M, Karamali M, Tajabadi-Ebrahimi M, Jafari P, Taghizadeh M, Memarzadeh MR, Asemi Z. Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. Hum Fertil (Camb). 2017 Dec;20(4):254-261. doi: 10.1080/14647273.2017.1283446. Epub 2017 Feb 1.
PubMed 28142296Shoaei T, Heidari-Beni M, Tehrani HG, Feizi A, Esmaillzadeh A, Askari G. Effects of Probiotic Supplementation on Pancreatic beta-cell Function and C-reactive Protein in Women with Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Clinical Trial. Int J Prev Med. 2015 Mar 24;6:27. doi: 10.4103/2008-7802.153866. eCollection 2015.
PubMed 25949777Karamali M, Eghbalpour S, Rajabi S, Jamilian M, Bahmani F, Tajabadi-Ebrahimi M, Keneshlou F, Mirhashemi SM, Chamani M, Hashem Gelougerdi S, Asemi Z. Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Arch Iran Med. 2018 Jan 1;21(1):1-7.
PubMed 29664663Liao D, Zhong C, Li C, Mo L, Liu Y. Meta-analysis of the effects of probiotic supplementation on glycemia, lipidic profiles, weight loss and C-reactive protein in women with polycystic ovarian syndrome. Minerva Med. 2018 Dec;109(6):479-487. doi: 10.23736/S0026-4806.18.05728-2. Epub 2018 Sep 24.
PubMed 30256077
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Probiotics, Metformin and Their Combination Therapy in Improving Symptoms of Polycystic Ovarian Syndrome.̎- A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04009603
- Acronym / sponsor ID
- 651118UZPHA
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 5 Jul 2019 (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.
Polycystic ovary syndrome (PCOS) is a common gynecological state worldwide characterized by numerous small cysts in the ovaries mainly due to the imbalance of endocrine hormones in premenopausal women. Metformin is long being used for different symptoms of PCOS along with other medication. This study involves the assessment of different parameters of PCOS.
Detailed description
Polycystic ovary syndrome (PCOS) is a hormonal disorder affecting the women of reproductive age. It is a heterogeneous health condition that affects 1 in every 10 women of childbearing age. Women of all races and ethnicities are at risk for PCOS, but risk increases multiple folds if the BMI is greater than 30kg/m2. The common signs and symptoms, the women usually represent with are menstrual irregularities, hyperandrogenemia and multiple cysts in ovaries. The exact cause of PCOS is still unknown but genetic and obesity is considered to be the most common cause.
Metformin has been considered as the first line agent for the treatment of non-insulin dependent diabetes mellitus and up till now it has been used as a first line drug for PCOS. Despite its beneficial effects in PCOS it has several adverse effects. Moreover, patients usually seek two or more drugs along with metformin to relieve maximum symptoms of PCOS like for ovulation clomiphene citrate must be given etc. So there is a need of novel and comprehensive agent that can prove to be effective in improving maximum symptoms of this disease. Probiotics have received renewed attention in the 21st century through research studies. World Health Organization's (WHO) 2001 defines probiotics as live micro-organisms that, when administered in adequate amounts, confer a health benefit on the host. In recent year it has shown tremendous promising effect in treatment of different diseases like diarrhea, gingivitis and obesity etc with negligible side effects.
In this context the investigators are going to evaluate and compare the effects of probiotics, metformin and their combination therapy in treatment of various symptoms of PCOS.60 newly diagnosed PCOS patient will be assigned in the open label randomized clinical trial. As mentioned above patients will be divided into three groups with 20 patients each. In group 1, the dosage of metformin will be 500mg B.D and 2 gm of probiotic sachet O.D, the second group will be given metformin 500mg B.D. and the third group will be 2mg of probiotics B.D. It would be a follow-up study that would be conducted in Gynecology OPD of Tertiary Care Hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminGroup no 1(26 patients) Metformin tablets at a dose of 500mg BD for 12 weeks |
| Probiotic | Experimental | Drug: Probiotic AgentGroup no 2(26 patients): will be given probiotics alone at a dose of 180mg B.D for 12 weeks |
| Metformin and Probiotic | Experimental | Drug: Probiotic Agent, Drug: MetforminGroup no 3(26 patients): will be given metformin 500mg B.D and probiotics 180mgram O.D. for 12 week |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patient will be included according to the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine sponsored a PCOS consensus criterion which says the presence of any two of the following three features must be present for the patient to be diagnosed as a case of PCOS:
Key exclusion criteria (6 listed)
- History of chronic diseases
- Allergic to probiotic or metformin
- Current or previous (within the last 6 months) use of chemotherapy or other drugs.
- History of smoking
- Individuals with autoimmune disease
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 |
|---|---|---|
| Probiotic AgentAlso: EcotecProbiotics are live microorganisms, which when administered in adequate amounts confer a health benefit effects on the host. Many clinical trials have been done on probiotic which show its use as a single or as an adjuvant drug therapy for various diseases with no or rare side effects. It is now frequently used agent for various diseases. Apart from this many studies have been published related to effects of probiotics on PCOS, which shows effectiveness of probiotics when used for 8 to 12 weeks with no adverse effects observed by these micro-organisms but none of the study have compare it with standarad drug | Drug | Metformin and Probiotic, Probiotic |
| MetforminAlso: glucophageMetformin, an insulin sensitizer, is an oral biguanide that is most commonly prescribed for the management of type II diabetes mellitus and various symptoms of PCOS. It is derived from the extract of Galega officinalis. It remediates hyperglycemia through activation of AMPK which stimulates glucose uptake and its consumption; promote fatty acid oxidation along with suppression of hepatic glucose production. It is also involved in increase GLUT4 translocation in the muscle and fat leading to decrease hepatic lipid synthesis. Moreover, It is also reported that it decreases gut absorption of glucose by increasing the glucagon-like peptide-1 (GLP-1) in this way, it reduces the insulin requirement too.All of these actions of metformin decrease insulin resistance and thus improve the state of hyperinsulinemia associated with diabetes and PCOS | Drug | Metformin, Metformin and Probiotic |
Primary outcome
Biochemical parameter:
Time frame: 12 weeks
Fasting serum glucose: The blood sample for FBS will be collected on day 2 or 3 of the menses. The blood samples will be taken before the start and at the end of the treatment. fasting glucose 80-100 mg/dl
Hormonal parameter:
Time frame: 12 weeks
Androgens: The concentration of these hormones will be evaluated at the baseline and at the end of treatment usually in the morning between 8:00 am to 9:00 am after overnight fasting Serum testosterone:15 and 70 ng/dL
Change in cyst size on Ultrasonography
Time frame: 12 weeks
Ovary cyst size: The size of the cyst will be measured before the start and at the end of the study, considering 12 or more follicles in at least 1 ovary or both-measuring 2-9 mm in diameter-or a total ovarian volume greater than 10 cm3
Luteinizing Hormone
Time frame: 12 weeks
LH The concentration of this endocrine hormones is determined will be obtained on day 2 or 3 of the normal menstruation cycle and at any time in women with amenorrhea. LH: 1.9 to 12.5 IU/L
INSULIN LEVELS
Time frame: 12 weeks
Fasting serum insulin: The sample is collected after fasting of 12 to 14 hours will be measured before and after intervention fasting insulin < 25 mIU/L
Lipid
Time frame: 12 weeks
Lipid profile: 1. Total cholesterol 2. LDL 3. HDL 4. Triglyceride The serum lipid concentrations will be evaluated spectrophotometrically by means of commercial kits at baseline and at the end of the study Total cholesterol < 200 Triglyceride: <150 mg/dl HDL: > 60mg/ dl LDL: < 130mg /dl
Follicle-stimulating hormone
Time frame: 12 weeks
The concentration of this endocrine hormones is determined will be obtained on day 2 or 3 of the normal menstruation cycle and at any time in women with amenorrhea. LH: 4.5 to 21.5 IU/L
LH and FSH ratio
Time frame: 12 weeks
LH:FSH The serum levels of FSH:LH ratio will be assessed before the start and at the end of the management on day 2 or 3 of the normal menses and at any time in women with amenorrhea. 1.5:1
4 secondary outcomes
Change in Physical symptoms in PCOS
Time frame: 12 weeks
Menstruration
Time frame: 12 weeks
Hirsutism
Time frame: 12 week
Acne
Time frame: 12 week
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 7 Jul 2020.
- Results publication: PubMed 28142296Ahmadi S, Jamilian M, Karamali M, Tajabadi-Ebrahimi M, Jafari P, Taghizadeh M, Memarzadeh MR, Asemi Z. Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. Hum Fertil (Camb). 2017 Dec;20(4):254-261. doi: 10.1080/14647273.2017.1283446. Epub 2017 Feb 1.
- Results publication: PubMed 25949777Shoaei T, Heidari-Beni M, Tehrani HG, Feizi A, Esmaillzadeh A, Askari G. Effects of Probiotic Supplementation on Pancreatic beta-cell Function and C-reactive Protein in Women with Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Clinical Trial. Int J Prev Med. 2015 Mar 24;6:27. doi: 10.4103/2008-7802.153866. eCollection 2015.
- Results publication: PubMed 29664663Karamali M, Eghbalpour S, Rajabi S, Jamilian M, Bahmani F, Tajabadi-Ebrahimi M, Keneshlou F, Mirhashemi SM, Chamani M, Hashem Gelougerdi S, Asemi Z. Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Arch Iran Med. 2018 Jan 1;21(1):1-7.
- Results publication: PubMed 30256077Liao D, Zhong C, Li C, Mo L, Liu Y. Meta-analysis of the effects of probiotic supplementation on glycemia, lipidic profiles, weight loss and C-reactive protein in women with polycystic ovarian syndrome. Minerva Med. 2018 Dec;109(6):479-487. doi: 10.23736/S0026-4806.18.05728-2. Epub 2018 Sep 24.
- Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trialLink provided by the sponsor.
- Effects of Probiotic Supplementation on Pancreatic β-cell Function and C-reactive Protein in Women with Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Clinical TriaLink provided by the sponsor.
- Meta-analysis of the effects of probiotic supplementation on glycemia, lipidic profiles, weight loss and C-reactive protein in women with polycystic ovarian syndrome.Link provided by the sponsor.
- 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.Urooj Zafar, M.Phil principal investigator
Ziauddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Agent and Metformin in people with Polycystic Ovary Syndrome, run by Ziauddin University 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 4 inclusion and 6 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 7 Jul 2020. 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.
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?
Biochemical parameter: (time frame: 12 weeks). The study lists 8 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 NCT04009603, which also lists 4 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 7 Jul 2020.