Double Blind Randomized Placebo-control Trial of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
试验速览
- 阶段
- 1 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- pain (visual analogue scale(0-10))
研究概览
简要总结
Purpose of study is evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy in management of symptomatic hemorrhoids in a double blind randomized placebo-control trial
详细描述
Purpose of study: evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy for the management of hemorrhoids study design:Double blind randomized placebo-control trial, uni-central Study population: Participants having symptomatic hemorrhoids attending Shiraz University of Medical Sciences clinics Inclusion criteria: Patients with symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination Exclusion criteria: Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer Sample size: 75 patients (tree groups) Interventions: Topical Allium ampeloprasum cream/ placebo cream/anti-hemorrhoid cream Time period: 3 week Outcome measures: pain,itching, bleeding, defecate discomfort, total improvement, constipation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participants having anal fissure or inflammatory bowel disease or history of gastrointestinal cancer
- •Participants having hypersensitive predisposition or hypersensitive to Allium ampeloprasum or history of skin hypersensivity
- •Female participants under pregnancy or during breastfeeding period
- •Participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or neurologic disorders or ascitis g- history of steroid or anticoagulant drug consumption
研究组 & 干预措施
placebo
placebo topical cream 2 cc twice daily for 3 weeks
干预措施: placebo topical cream (Drug)
Anti-hemorrhoid topical cream drug
Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week
干预措施: Anti-hemorrhoid topical cream (Drug)
Leek topical cream
Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
干预措施: Leek topical cream (Drug)
结局指标
主要结局
pain (visual analogue scale(0-10))
时间窗: 3 weeks
method of measurement: visual analogue scale(0-10)
bleeding ( questionnaire)
时间窗: 3 weeks
method of measurement questionnaire:grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe.
itching ( questionnaire)
时间窗: 3 weeks
method of measurement questionnaire: grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe.
defecate discomfort (visual analogue scale(0-10)
时间窗: 3 weeks
method of measurement: visual analogue scale(0-10)
total improvement (visual analogue scale(0-10)
时间窗: 3 weeks
method of measurement:visual analogue scale(0-10)
次要结局
- constipation (questionnaire)(3 weeks)
研究者
Leyla Ghahramani
Shiraz university of medical sciences
Shiraz University of Medical Sciences