Randomised, Double-blind, Placebo-controlled to Assess the Efficacy and Safety of the Food Supplement Microsmin® Plus

NCT05750563 | Unknown

• 1 other identifier: OPGIE/0122/FS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Haemorrhoids are variceal dilatations of the anal and perianal venous plexus and often develop secondary to the persistently elevated venous pressure within the haemorrhoidal plexus . The classical position of haemorrhoids corresponds to three positions which are the right anterior, right posterior and the left lateral areas of the anal canal. Haemorrhoids may be external or internal. External haemorrhoids are covered with skin and internal haemorrhoids are covered with anal mucous membranes. The grading system used by Banov to classify internal haemorrhoids is one of the most common grading systems used by clinicians and is used to guide therapeutic practice. Internal haemorrhoids can be divided into four categories depending on the degree of prolapse (the protrusion of the haemorrhoid through the anus). The most widely accepted classification is the Goligher classification:

• Bleeding but no prolapse (grade I).
• Hemorrhoidal piles prolapse through the anus during straining, but they reduce spontaneously (grade II).
• Hemorrhoidal piles prolapse through the anus during straining and require manual reduction (grade III).
• The prolapse is irreducible (grade IV). Most symptoms and signs which patients present with arise from internal haemorrhoids, derive from structural changes of the normal anatomic padding (enlarged internal haemorrhoids) and are generally associated with chronic straining either due to constipation, diarrhoea or prolonged periods trying to defecate. They are also common during pregnancy and childbirth.

Conditions

Haemorrhoids

Keywords

haemorrhoids

Outcome Measures

Primary Outcomes (2)

• To evaluate the efficacy of the tested food supplement Microsmin® Plus

  Evaluate the efficacy of the tested food supplement Microsmin® Plus (diosmin and micronized flavonoids) in comparison with placebo in the symptomatic treatment of haemorrhoids in adult patients affected by Grade I-II (Goligher classification) haemorrhoids as assessed by the patient at the end of the treatment period.

  63 days

• To evaluate the safety of the tested food supplement through adverse events and serious adverse events incidence assessed by Investigators and reported according to the current legislation

  To evaluate the safety of the tested food supplement through AE and SAE incidence assessed by Investigators and reported according to the current legislation.

  63 days

Secondary Outcomes (5)

• To evaluate the early efficacy of the tested food supplement in comparison with placebo in the symptomatic treatment of haemorrhoids as assessed by the patient after 4 and 7 days of treatment

  63 days

• To evaluate the efficacy of the tested food supplement in comparison with placebo in the clinical improvement of haemorrhoids as assessed by the Investigator at each visit (day 7 and 63)

  63 days

• To evaluate analgesic consumption in patients treated with the tested food supplement in comparison with placebo as reported by the patient in the diary

  63 days

• To assess the overall satisfaction with the tested food supplement in comparison with placebo according to patient's judgement, at the end of the treatment period (day 63)

  63 days

• To assess the improvement in the quality of life by means of the Short Heath Scale for Hemorrhoidal Disease (SHSHD) score; assessed by patients after 7 and 63 days of treatment

  63 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Investigational food supplement placebo will be administered according to the same schedule provided for the active product: * From day 1 to day 4: 1 tablet three times a day, before meals (breakfast, lunch and dinner) * From day 5 to day 7: 1 tablet twice a day, before breakfast and dinner * From day 8 to day 62: 1 tablet once a day, before breakfast

Other: Placebo

Experimental

EXPERIMENTAL

The dosage will be the following: * From day 1 to day 4: 1 tablet three times a day, before meals (breakfast, lunch and dinner) * From day 5 to day 7: 1 tablet twice a day, before breakfast and dinner * From day 8 to day 62: 1 tablet once a day, before breakfast

Dietary Supplement: diosmin and micronized flavonoids

Interventions

diosmin and micronized flavonoids DIETARY_SUPPLEMENT

the symptomatic treatment of haemorrhoids

Also known as: MICROSMIN® PLUS

Experimental

Placebo OTHER

Use as comparator

Placebo

Eligibility Criteria

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

You may qualify if:

• Men or women aged ≥ 18 and ≤ 60 years. The sex will be balanced by randomized stratification.
• Patients diagnosed with Grade I - II symptomatic haemorrhoids (according to Goligher classification) confirmed by clinical and anoscopic or proctoscopic examination performed within 3 months before baseline. Ultrasound examination at baseline is recommended, but not mandatory.
• Patient free from the following treatments for haemorrhoids from at least 4 weeks: laser treatments for haemorrhoids, steroidal or non-steroidal anti-inflammatory drugs, analgesics (other than the rescue medicine indicated in the protocol), any anti-hemorrhoidal treatment (included phlebotonic compounds both drugs and dietary supplements), anticoagulants, and antiplatelet agents.
• 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.

You may not qualify if:

• Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Diseases).
• Acute haemorrhoids or complicated haemorrhoids with bleeding requiring admission, such as strangulated internal haemorrhoids, thrombosed internal or external haemorrhoids.
• Previous haemorrhoidectomy or previous laser treatment.
• Moderate to severe hypertension, cardiovascular diseases, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula.
• Alcohol or drug abuse.
• Patients considered smokers (≥10 cigarettes/day).
• Energy-restricted diet for weight loss.
• Pregnant woman, lactating woman, and woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\* during the study.
• \*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
• Hypersensitivity to active principle (diosmin) or to any other ingredient contained in the tested food supplement.
• History of anaphylaxis or severe complicated allergy symptoms.
• Patients unlikely to cooperate.
• Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study.
• Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

Sponsors & Collaborators

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

Study Sites (1)

SC Salvosan Ciobanca SRL

Zalău, Sălaj County, Romania

Location

Related Publications (43)

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MeSH Terms

Conditions

Hemorrhoids

Interventions

Diosmin

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Fabio Terruzzi, CSO

  Giellepi S.p.A

  STUDY DIRECTOR

Central Study Contacts

Dionisio F. Barattini, MD

CONTACT

+39 3355437574; barattini@operacro.com

Marius Ardelean, MD

CONTACT

+40 726266031; marius.ardelean@tigermedgrp.com

Study Design

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

Model Details: DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP OF THE FOOD SUPPLEMENT MICROSMIN® PLUS (DIOSMIN AND MICRONIZED FLAVONOIDS)

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 1, 2023
• Study Start: February 28, 2023
• Primary Completion: October 15, 2023
• Study Completion: December 30, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)