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Completed

NCT Number: NCT04101201

Clinical Trial to Assess the Efficacy of µSmin® Plus

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

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Key information

Conditions

Chronic Venous Disease

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SCM Gados

Timișoara, Timiș County, 300425, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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;

  7. 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

  8. AE/SAE incidence

    Time frame: 56 days

    Evaluation of safety during all the study period through AE/SAE collection

  9. 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.

Sponsors and collaborators

Lead sponsor

Giellepi S.p.A

Industry

Collaborators

  • Opera CRO, a TIGERMED Group Company

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2019
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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