Clinical Trial to Assess the Efficacy of µSmin® Plus

June 23, 2020 updated by: Giellepi S.p.A

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300425
        • SCM Gados

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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;
  • Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: µSmin® Plus
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
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.
PLACEBO_COMPARATOR: Placebo
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
56 days
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.
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale ( VAS scale ) from 0 to 10 for pain measurements
Time Frame: 56 days
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.
56 days
Symptoms relief assessed by Venous Clinical Severity Score (VCSS) questionnaire
Time Frame: 56 days
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.
56 days
Investigator Global Assessment of the efficacy by scoresproduct
Time Frame: 56 days
Efficacy of treatment: Percentage of physicians who rated 1= excellent, 2 = good, 3= fair, 4= poor
56 days
Patient Global Assessment of the efficacy by scores
Time Frame: 56 days
Patients satisfaction: 1= very satisfied, 2= satisfied, 3 = adequate, 4= unsatisfied, 5 = very unsatisfied
56 days
Percentage of subjects who would want to continue with µSmin® Plus.
Time Frame: 56 days
By this outcome we want to find out the percentage of patients who will want to continue with µSmin® Plus.
56 days
Percentage of subjects who experienced symptoms relief
Time Frame: 56 days
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;
56 days
Treatment compliance
Time Frame: 56 days
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
56 days
AE/SAE incidence
Time Frame: 56 days
Evaluation of safety during all the study period through AE/SAE collection
56 days
Investigator Global Assessment of Safety (IGAS):
Time Frame: 56 days
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.
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giellepi S.p.A

Collaborators

Opera CRO, a TIGERMED Group Company

Investigators

  • Principal Investigator: Doina Rosu, MD, SCM Dr. Rosu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2019

Primary Completion (ACTUAL)

April 24, 2020

Study Completion (ACTUAL)

April 24, 2020

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (ACTUAL)

September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CR2019/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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