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

Launched by GIELLEPI S.P.A · Feb 28, 2023

Keywords

ClinConnect 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 gradi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men or women aged ≥ 18 and ≤ 60 years. The sex will be balanced by randomized stratification.
• • 2. 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.
• • 3. 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.
• • 4. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
• • 5. Capable of and freely willing to provide written informed consent prior to participating in the study.
• Exclusion Criteria:
• • 1. Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Diseases).
• • 2. Acute haemorrhoids or complicated haemorrhoids with bleeding requiring admission, such as strangulated internal haemorrhoids, thrombosed internal or external haemorrhoids.
• • 3. Previous haemorrhoidectomy or previous laser treatment.
• • 4. Moderate to severe hypertension, cardiovascular diseases, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula.
• • 5. Use of 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 in the 4 weeks prior to inclusion and during the whole study.
• • 6. Alcohol or drug abuse.
• • 7. Patients considered smokers (≥10 cigarettes/day).
• • 8. Energy-restricted diet for weight loss.
• • 9. 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.).
• • 10. Hypersensitivity to active principle (diosmin) or to any other ingredient contained in the tested food supplement.
• • 11. History of anaphylaxis or severe complicated allergy symptoms.
• • 12. Patients unlikely to cooperate.
• • 13. 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.
• • 14. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.