NCT05124379已完成不适用
Prospective, Open Clinical Investigation to Confirm the Effectiveness and Safety of Hemoclin Gel for the Treatment of Haemorrhoids.
Karo Pharma AB1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.
研究概览
简要总结
Post market, single arm, clinical investigation to assess safety and performance of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects.
- •Sex: male or female.
- •Age: more than 18 years old.
- •Symptomatic haemorrhoids stage 1 and 2 (Goligher classification).
- •Episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study.
- •Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily, whether or not you feel the need to have a bowel movement that day).
- •Able and willing to provide informed consent and comply with study procedures
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Subject not able or not willing to provide informed consent and comply with study procedures
- •Subject who had been deprived of their freedom by administrative or legal decision.
- •Major subject who is under guardianship or who is not able to express his consent.
- •Subject in a social or sanitary establishment.
- •Subject suspected to be non-compliant according to the Investigator's judgment. In terms of associated pathology
- •Grade III or IV haemorrhoids (Goligher classification).
- •Other pre-existing anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections.
- •Any anal surgery (including surgical or instrumental procedures in the last 60 days). Relating to previous or ongoing treatment
- •Any anal topical medication applied in last 7 days.
- •Known or suspected sensitivity or allergy to ingredients of the investigational product. In terms of COVID pandemic
- •Subject who was abroad in a country with higher incidence rate of Covid-19 than Poland within 14 days before the beginning of the study.
- •Subject presenting following symptoms: cough, shortness of breath, elevated body temperature - equal and above 37.5°C.
- •Subject who had contact with any person infected with COVID-19 within 10 days before the beginning of the study.
- •Subject who is currently during home quarantine recommended by the Sanitary Inspection
结局指标
主要结局
The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.
时间窗: 2 weeks
Severity of itch will be evaluated by the patient with a 6 point structured scale.
次要结局
- To evaluate the overall satisfaction of the patient according to(2 weeks)
- To evaluate the instant cooling effect, less painful toilet visit each day using a daily log,(2 weeks)
- To evaluate by the patient the efficacy of tested product on the severity of bleeding(2 weeks)
- To evaluate by the patient the efficacy of tested product on the sense of discomfort(2 weeks)
研究者
研究点 (1)
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