Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre, Interventional Clinical Trial to Assess the Efficacy and Safety of the Food Supplement Microsmin® Plus in the Symptomatic Treatment of Haemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of the tested food supplement Microsmin® Plus
研究概览
简要总结
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.
详细描述
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.
The acute clinical manifestation of the hemorrhoidal disease (commonly known as "hemorrhoidal crisis") is characterized by symptoms and signs, also common in chronic pathologies, such as rectal bleeding, prolapse, pruritus (itching), pain, oedema, often thrombosis, and less frequently soiling or mucoid discharge. Rectal bleeding (the most common presenting sign) is classically bright red as there is a high blood oxygen content within the arteriovenous anastomosis. This bleeding is usually described as bright red spotting on the toilet tissue or dripping in the toilet bowl and normally occurs at the end of defecation, separately from the stool. External haemorrhoids may be asymptomatic or associated with discomfort or with acute extreme pain in the event of a local thrombosis (formation of a clot).
Phlebotonics are a heterogenous class of drugs consisting of plant extracts (i.e., flavonoids) and synthetic compounds. Although their precise mechanism of action has not been fully established, they are known to strengthen blood vessel walls, improve venous tone, stabilise capillary permeability and increase lymphatic drainage. They have been used to treat a variety of conditions including chronic venous insufficiency, lymphoedema and haemorrhoids. In particular, numerous trials assessing the effect of phlebotonics in treating the symptoms and signs of haemorrhoidal disease (they are generally used in the less severe stages of haemorrhoids, first and second-grade haemorrhoids and during the thrombosis episodes) suggest that there is a potential benefit. Moreover, 2 reviews and 1 systematic review evaluated the micronized purified flavonoid fraction (MPFF) activities and performance in haemorrhoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
- •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.
结局指标
主要结局
To evaluate the efficacy of the tested food supplement Microsmin® Plus
时间窗: 63 days
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.
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
时间窗: 63 days
To evaluate the safety of the tested food supplement through AE and SAE incidence assessed by Investigators and reported according to the current legislation.
次要结局
- 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)
- 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)