NCT05750563

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

Status unknown NA Last updated 1 March 2023

What this trial tests

NA trial testing diosmin and micronized flavonoids in Haemorrhoids in 80 participants. Status unknown.

Timeline

28 February 2023

Primary endpoint
15 October 2023

30 December 2023

Quick facts

Lead sponsor	Giellepi S.p.A
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	28 February 2023
Primary completion	15 October 2023
Estimated completion	30 December 2023
Sites	1 location across Romania

Drugs / interventions tested

• diosmin and micronized flavonoids
• Placebo

Conditions studied

• Haemorrhoids — all drugs for Haemorrhoids →

Sponsor

Giellepi S.p.A

Who can join

Adults 18 to 60, any sex, with Haemorrhoids. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.