Clinical Trial to Assess the Efficacy of µSmin® Plus

NCT04101201 | Completed

• 1 other identifier: CR2019/21
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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 circumference of the affected leg at calf level

Conditions

Chronic Venous Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  56 days

Secondary Outcomes (9)

• Visual Analogue Scale ( VAS scale ) from 0 to 10 for pain measurements

  56 days

• Symptoms relief assessed by Venous Clinical Severity Score (VCSS) questionnaire

  56 days

• Investigator Global Assessment of the efficacy by scoresproduct

  56 days

• Patient Global Assessment of the efficacy by scores

  56 days

• Percentage of subjects who would want to continue with µSmin® Plus.

  56 days

Study Arms (2)

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.

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

Other: Placebo

Interventions

µSmin® Plus DIETARY_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.

µSmin® Plus

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Giellepi S.p.A: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

SCM Gados

Timișoara, Timiș County, 300425, Romania

Location

Related Publications (20)

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• 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.

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• 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.

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Study Officials

• Doina Rosu, MD

  SCM Dr. Rosu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: November 15, 2019
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

RO (1)