Chronic Venous DiseaseNCT04101201

Clinical Trial to Assess the Efficacy of µSmin® Plus

A study testing µSmin® Plus in people with Chronic Venous Disease, run by Giellepi S.p.A at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluates treatment with the dietary supplement µSmin® Plus in a group of patients suffering from chronic venous insufficiency in comparison with a similarly-sized group of patients receiving placebo evaluated by quality of life questionnaires, VAS pain scale, CVI symptomatology, and change in the… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Chronic Venous Disease
What is being tested?: µSmin® Plus
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 73 participants
Where: 1 siteRomania
Study dates: 15 Nov 2019to 24 Apr 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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female with age ≥18 and ≤60 with chronic venous insufficiency;
The chronic venous insufficiency must be graded between C2-C4 on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system;
Able to communicate adequately with the investigator and to comply with the requirements for the entire study;
Capable of and freely willing to provide written informed consent prior to participating in the study;
Light smokers (<10 cigarettes per day).

Who cannot join

Patients suffering from other or associated vascular diseases, diabetes or bleeding disorders;
Oedema of the lower limbs of cardiac, renal or hepatic origin;
Presence of symptoms and/or trophic disorders of arterial, metabolic, neurological or orthopedic origin including traumas, arthritis, neuropathy;
One or more factors likely to affect venous symptoms such as recent childbirth, recent stripping, or deep or superficial venous thrombosis of the lower limbs during the previous 6 months;
Obese subjects (BMI > 30);
Hypersensitivity to active principles contained in the tested food supplement (diosmin);

Show all 11Show fewer

Patients considered smokers (≥10 cigarettes/day);
Patients with concomitant or history of addiction to alcohol, spices or drug abuse;
Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception;
Participation in an interventional clinical study in the previous 30 days;
Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.

Trial locations and contacts

1 site in 1 country.

Romania1 site

SCM Gados
Timișoara, Timiș County, 300425

Other trials in Romania

About this study

Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of µSmin® Plus (Dietary Supplement) in Chronic Venous Insufficiency Symptoms Relief

Read the detailed description

In this study we use a dietary supplement - µSmin® Plus - for symptomatic treatment of CVI and we will monitor its impact on CVI symptoms, features, and consequences (item) of the disease listed below: limb edema, walking, daily tasks performance, pain/burning symptoms, pruritus/paresthesis, sensation of heaviness/fatigue, time wasted in the management of the disease, social burden, disease impact on self-confidence, and its impact on physical exercise/recreational activities. Results of related clinical trials were published before showing that this is an active field in clinical reasearch.

Conditions: Chronic Venous Disease
Being tested: µSmin® Plus, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

µSmin® PlusDietary supplement
µSmin® Plus is a new Micronized Diosmin Formulation for oral administration. Diosmin is extremely well tolerated and safe to use. Diosmin is safe for most people when used short-term for up to 6 months. During the 8 weeks of the clinical investigation, the subject will administer 1 tablet of µSMIN® Plus (corresponding to 450 mg of micronized diosmin) or placebo per day.
PlaceboOther
It will be supplied by the Sponsor in an amount enough for the duration of the study. The subject will administer 1 tablet per day

Study groups in NCT04101201
Study group	Role	What they receive
µSmin® Plus	Other	µSmin® Plus is a new Micronized Diosmin Formulation for oral administration. Diosmin is extremely well tolerated and safe to use. Diosmin is safe for most people when used short-term for up to 6 months. During the 8 weeks of the clinical investigation, the subject will administer 1 tablet of µSMIN® Plus (corresponding to 450 mg of micronized diosmin) or placebo per day. Receives: Dietary Supplement: µSmin® Plus
Placebo	Placebo comparator	It will be supplied by the Sponsor in an amount enough for the duration of the study. The subject will administer 1 tablet per day Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of life assessed
Quality of life is assessed by ChronIc Venous Insuficiency quality of life Questionnaire ( CIVIQ-20 questionnaire ). The 20-item questionnaire, provides a global index and an outline of 4 quality-of-life dimensions-"pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). Items on the CIVIQ-20 scale were scored from 1 to 5. There are 20 questions in the CIVIQ-20, each with 5 possible answers (1 to 5), the minimum possible score being 20 and the maximum 100. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (100-20=80), multiplied by 100. A low score will correspond to greater patient comfort.
Measured: 56 days
Change in the circumference of each affected leg
To evaluate the efficacy of the dietary supplement µSmin® Plus on ameliorating the symptoms of Chronic Venous Insufficiency in terms of change in the circumference of affected legs and quality of life, in comparison with placebo, from baseline to week 8 visit; The unit for this measurement is centimeter.
Measured: 56 days

Secondary outcomes (9)

Visual Analogue Scale ( VAS scale ) from 0 to 10 for pain measurements
Visual Analogue Scale is a straight horizontal line of 100 mm. The ends are defined as the extreme limits of the pain (symptom, pain, health) orientated from the left (worst) to the right (best). Using a ruler, the score is determined by measuring the distance in millimeters on the 10 centimeters line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity and a low score indicates a low pain intensity.
Measured: 56 days
Symptoms relief assessed by Venous Clinical Severity Score (VCSS) questionnaire
Venous Clinical Severity Score use the progressive ranking of severity, while weighting the upper levels representing the more severe presentations of Chronical Venous Disease. The lowest possible score is 0=absent meaning that the patient has no symptoms and the highest possible score is 30=sever meaning that the patient has a very severe venous symptoms.
Measured: 56 days
Investigator Global Assessment of the efficacy by scoresproduct
Efficacy of treatment: Percentage of physicians who rated 1= excellent, 2 = good, 3= fair, 4= poor
Measured: 56 days
Patient Global Assessment of the efficacy by scores
Patients satisfaction: 1= very satisfied, 2= satisfied, 3 = adequate, 4= unsatisfied, 5 = very unsatisfied
Measured: 56 days
Percentage of subjects who would want to continue with µSmin® Plus.
By this outcome we want to find out the percentage of patients who will want to continue with µSmin® Plus.
Measured: 56 days
Percentage of subjects who experienced symptoms relief
Percentage of subjects who experienced symptoms relief within the first week of intake, within 2 weeks of intake, or more than 2 weeks of intake;
Measured: 56 days
Treatment compliance
Variable medication possession ratio (VMPR) will be used to calculate the compliance (or adherence) to the treatment in the two groups collected by diary card and used and unused products
Measured: 56 days
AE/SAE incidence
Evaluation of safety during all the study period through AE/SAE collection
Measured: 56 days
Investigator Global Assessment of Safety (IGAS):
Investigator Global Assessment of Safety (IGAS): using the 4-point scale:1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated at the last visit.
Measured: 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201924 Apr 2020

First posted24 Sep 2019
Study start15 Nov 2019
Primary completion24 Apr 2020
Study completion24 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Chronic Venous DiseaseStudies 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: Randomised
Intervention model: Parallel groups
Model description: Diosmin is a naturally occurring flavonoid present in citrus fruits and other plants belonging to the Rutaceae family. It is used for the treatment of chronic venous insufficiency (CVI) for its pheblotonic and vaso-active properties, safety and tolerability as well. µSmin® Plus is a proprietary flavonoid complex with enhanced bio-efficacy. It contains highly concentrated micronized and standardized Diosmin. Highly improved bioavailability and improved oral absorption by micronization of the particles.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04101201
Sponsor's protocol ID: CR2019/21
Status last verified: Jun 2020
First submitted: 20 Sep 2019
Last updated: 25 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.
PubMed 18467617
Onida S, Davies AH. Predicted burden of venous disease. Phlebology. 2016 Mar;31(1 Suppl):74-9. doi: 10.1177/0268355516628359.
PubMed 26916773
Carpentier PH, Maricq HR, Biro C, Poncot-Makinen CO, Franco A. Prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg. 2004 Oct;40(4):650-9. doi: 10.1016/j.jvs.2004.07.025.
PubMed 15472591
Malone PC, Agutter PS. To what extent might deep venous thrombosis and chronic venous insufficiency share a common etiology? Int Angiol. 2009 Aug;28(4):254-68.
PubMed 19648868
Russo R, Mancinelli A, Ciccone M, Terruzzi F, Pisano C, Severino L. Pharmacokinetic Profile of microSMIN Plus, a new Micronized Diosmin Formulation, after Oral Administration in Rats. Nat Prod Commun. 2015 Sep;10(9):1569-72.
PubMed 26594761
Russo R, Chandradhara D, De Tommasi N. Comparative Bioavailability of Two Diosmin Formulations after Oral Administration to Healthy Volunteers. Molecules. 2018 Aug 29;23(9):2174. doi: 10.3390/molecules23092174.
PubMed 30158431
Belczak SQ, Sincos IR, Campos W, Beserra J, Nering G, Aun R. Veno-active drugs for chronic venous disease: A randomized, double-blind, placebo-controlled parallel-design trial. Phlebology. 2014 Aug;29(7):454-60. doi: 10.1177/0268355513489550. Epub 2013 May 16.
PubMed 23761871
Zolotukhin IA, Seliverstov EI, Shevtsov YN, Avakiants IP, Nikishkov AS, Tatarintsev AM, Kirienko AI. Prevalence and Risk Factors for Chronic Venous Disease in the General Russian Population. Eur J Vasc Endovasc Surg. 2017 Dec;54(6):752-758. doi: 10.1016/j.ejvs.2017.08.033. Epub 2017 Oct 12.
PubMed 29031868
Vuylsteke ME, Thomis S, Guillaume G, Modliszewski ML, Weides N, Staelens I. Epidemiological study on chronic venous disease in Belgium and Luxembourg: prevalence, risk factors, and symptomatology. Eur J Vasc Endovasc Surg. 2015 Apr;49(4):432-9. doi: 10.1016/j.ejvs.2014.12.031. Epub 2015 Feb 18.
PubMed 25701071
Lichota A, Gwozdzinski L, Gwozdzinski K. Therapeutic potential of natural compounds in inflammation and chronic venous insufficiency. Eur J Med Chem. 2019 Aug 15;176:68-91. doi: 10.1016/j.ejmech.2019.04.075. Epub 2019 May 6.
PubMed 31096120
Rabe E, Guex JJ, Morrison N, Ramelet AA, Schuller-Petrovic S, Scuderi A, Staelens I, Pannier F. Treatment of chronic venous disease with flavonoids: recommendations for treatment and further studies. Phlebology. 2013 Sep;28(6):308-19. doi: 10.1177/0268355512471929. Epub 2013 May 6.
PubMed 23395842
Lebeau J, Furman C, Bernier JL, Duriez P, Teissier E, Cotelle N. Antioxidant properties of di-tert-butylhydroxylated flavonoids. Free Radic Biol Med. 2000 Nov 1;29(9):900-12. doi: 10.1016/s0891-5849(00)00390-7.
PubMed 11063915
Panche AN, Diwan AD, Chandra SR. Flavonoids: an overview. J Nutr Sci. 2016 Dec 29;5:e47. doi: 10.1017/jns.2016.41. eCollection 2016.
PubMed 28620474
Bakhtiari M, Panahi Y, Ameli J, Darvishi B. Protective effects of flavonoids against Alzheimer's disease-related neural dysfunctions. Biomed Pharmacother. 2017 Sep;93:218-229. doi: 10.1016/j.biopha.2017.06.010. Epub 2017 Jun 20.
PubMed 28641164
Milano G, Leone S, Fucile C, Zuccoli ML, Stimamiglio A, Martelli A, Mattioli F. Uncommon serum creatine phosphokinase and lactic dehydrogenase increase during diosmin therapy: two case reports. J Med Case Rep. 2014 Jun 16;8:194. doi: 10.1186/1752-1947-8-194.
PubMed 24934505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of µSmin® Plus (Dietary Supplement) in Chronic Venous Insufficiency Symptoms Relief
ClinicalTrials.gov ID: NCT04101201
Acronym / sponsor ID: CR2019/21
Conditions: Chronic Venous Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Giellepi S.p.AIndustry (pharma, biotech, devices)
Collaborators: Opera CRO, a TIGERMED Group Company
Study start: 15 Nov 2019 (actual)
Primary completion: 24 Apr 2020 (actual)
Study completion: 24 Apr 2020 (actual)
First posted: 24 Sep 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Diosmin is a naturally occurring flavonoid present in citrus fruits and other plants belonging to the Rutaceae family. It is used for the treatment of chronic venous insufficiency (CVI) for its pheblotonic and vaso-active properties, safety and tolerability as well. µSmin® Plus is a proprietary flavonoid complex with enhanced bio-efficacy. It contains highly concentrated micronized and standardized Diosmin. Highly improved bioavailability and improved oral absorption by micronization of the particles.

Arm	Type	Receives
µSmin® Plus	Other	Dietary Supplement: µSmin® PlusµSmin® Plus is a new Micronized Diosmin Formulation for oral administration. Diosmin is extremely well tolerated and safe to use. Diosmin is safe for most people when used short-term for up to 6 months. During the 8 weeks of the clinical investigation, the subject will administer 1 tablet of µSMIN® Plus (corresponding to 450 mg of micronized diosmin) or placebo per day.
Placebo	Placebo comparator	Other: PlaceboIt will be supplied by the Sponsor in an amount enough for the duration of the study. The subject will administer 1 tablet per day

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female with age ≥18 and ≤60 with chronic venous insufficiency;
The chronic venous insufficiency must be graded between C2-C4 on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system;
Able to communicate adequately with the investigator and to comply with the requirements for the entire study;
Capable of and freely willing to provide written informed consent prior to participating in the study;
Light smokers (<10 cigarettes per day).

Key exclusion criteria (11 listed)

Patients suffering from other or associated vascular diseases, diabetes or bleeding disorders;
Oedema of the lower limbs of cardiac, renal or hepatic origin;
Presence of symptoms and/or trophic disorders of arterial, metabolic, neurological or orthopedic origin including traumas, arthritis, neuropathy;
One or more factors likely to affect venous symptoms such as recent childbirth, recent stripping, or deep or superficial venous thrombosis of the lower limbs during the previous 6 months;
Obese subjects (BMI > 30);

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
µSmin® PlusµSmin® Plus is a new Micronized Diosmin Formulation for oral administration. Diosmin is extremely well tolerated and safe to use. Diosmin is safe for most people when used short-term for up to 6 months. During the 8 weeks of the clinical investigation, the subject will administer 1 tablet of µSMIN® Plus (corresponding to 450 mg of micronized diosmin) or placebo per day.	Dietary supplement	µSmin® Plus
PlaceboIt will be supplied by the Sponsor in an amount enough for the duration of the study. The subject will administer 1 tablet per day	Other	Placebo

Primary outcome

Quality of life assessed
Time frame: 56 days
Quality of life is assessed by ChronIc Venous Insuficiency quality of life Questionnaire ( CIVIQ-20 questionnaire ). The 20-item questionnaire, provides a global index and an outline of 4 quality-of-life dimensions-"pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). Items on the CIVIQ-20 scale were scored from 1 to 5. There are 20 questions in the CIVIQ-20, each with 5 possible answers (1 to 5), the minimum possible score being 20 and the maximum 100. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (100-20=80), multiplied by 100. A low score will correspond to greater patient comfort.
Change in the circumference of each affected leg
Time frame: 56 days
To evaluate the efficacy of the dietary supplement µSmin® Plus on ameliorating the symptoms of Chronic Venous Insufficiency in terms of change in the circumference of affected legs and quality of life, in comparison with placebo, from baseline to week 8 visit; The unit for this measurement is centimeter.

9 secondary outcomes

Visual Analogue Scale ( VAS scale ) from 0 to 10 for pain measurements
Time frame: 56 days
Symptoms relief assessed by Venous Clinical Severity Score (VCSS) questionnaire
Time frame: 56 days
Investigator Global Assessment of the efficacy by scoresproduct
Time frame: 56 days
Patient Global Assessment of the efficacy by scores
Time frame: 56 days
Percentage of subjects who would want to continue with µSmin® Plus.
Time frame: 56 days
Percentage of subjects who experienced symptoms relief
Time frame: 56 days
Treatment compliance
Time frame: 56 days
AE/SAE incidence
Time frame: 56 days
Investigator Global Assessment of Safety (IGAS):
Time frame: 56 days

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 25 Jun 2020.
Background: PubMed 18467617Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.
Background: PubMed 26916773Onida S, Davies AH. Predicted burden of venous disease. Phlebology. 2016 Mar;31(1 Suppl):74-9. doi: 10.1177/0268355516628359.
Background: PubMed 15472591Carpentier PH, Maricq HR, Biro C, Poncot-Makinen CO, Franco A. Prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg. 2004 Oct;40(4):650-9. doi: 10.1016/j.jvs.2004.07.025.
Background: PubMed 19648868Malone PC, Agutter PS. To what extent might deep venous thrombosis and chronic venous insufficiency share a common etiology? Int Angiol. 2009 Aug;28(4):254-68.
Background: PubMed 26594761Russo R, Mancinelli A, Ciccone M, Terruzzi F, Pisano C, Severino L. Pharmacokinetic Profile of microSMIN Plus, a new Micronized Diosmin Formulation, after Oral Administration in Rats. Nat Prod Commun. 2015 Sep;10(9):1569-72.
Background: PubMed 30158431Russo R, Chandradhara D, De Tommasi N. Comparative Bioavailability of Two Diosmin Formulations after Oral Administration to Healthy Volunteers. Molecules. 2018 Aug 29;23(9):2174. doi: 10.3390/molecules23092174.
Background: PubMed 23761871Belczak SQ, Sincos IR, Campos W, Beserra J, Nering G, Aun R. Veno-active drugs for chronic venous disease: A randomized, double-blind, placebo-controlled parallel-design trial. Phlebology. 2014 Aug;29(7):454-60. doi: 10.1177/0268355513489550. Epub 2013 May 16.
Background: PubMed 29031868Zolotukhin IA, Seliverstov EI, Shevtsov YN, Avakiants IP, Nikishkov AS, Tatarintsev AM, Kirienko AI. Prevalence and Risk Factors for Chronic Venous Disease in the General Russian Population. Eur J Vasc Endovasc Surg. 2017 Dec;54(6):752-758. doi: 10.1016/j.ejvs.2017.08.033. Epub 2017 Oct 12.
Background: PubMed 25701071Vuylsteke ME, Thomis S, Guillaume G, Modliszewski ML, Weides N, Staelens I. Epidemiological study on chronic venous disease in Belgium and Luxembourg: prevalence, risk factors, and symptomatology. Eur J Vasc Endovasc Surg. 2015 Apr;49(4):432-9. doi: 10.1016/j.ejvs.2014.12.031. Epub 2015 Feb 18.
Background: PubMed 31096120Lichota A, Gwozdzinski L, Gwozdzinski K. Therapeutic potential of natural compounds in inflammation and chronic venous insufficiency. Eur J Med Chem. 2019 Aug 15;176:68-91. doi: 10.1016/j.ejmech.2019.04.075. Epub 2019 May 6.
Background: PubMed 23395842Rabe E, Guex JJ, Morrison N, Ramelet AA, Schuller-Petrovic S, Scuderi A, Staelens I, Pannier F. Treatment of chronic venous disease with flavonoids: recommendations for treatment and further studies. Phlebology. 2013 Sep;28(6):308-19. doi: 10.1177/0268355512471929. Epub 2013 May 6.
Background: PubMed 11063915Lebeau J, Furman C, Bernier JL, Duriez P, Teissier E, Cotelle N. Antioxidant properties of di-tert-butylhydroxylated flavonoids. Free Radic Biol Med. 2000 Nov 1;29(9):900-12. doi: 10.1016/s0891-5849(00)00390-7.

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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.

Doina Rosu, MD principal investigator

SCM Dr. Rosu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing µSmin® Plus in people with Chronic Venous Disease, run by Giellepi S.p.A at 1 site in Romania.

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 11 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 25 Jun 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 Romania. 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. Some participants in this study may receive a placebo. 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?

Quality of life assessed (time frame: 56 days). The study lists 2 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 NCT04101201, which also lists 20 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 25 Jun 2020.