Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Double Blind Randomized Placebo-control Trial of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms

Conditions
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Hemorrhoids

Intervention / Treatment
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* Drug: Leek topical cream
* Drug: placebo topical cream
* Drug: Anti-hemorrhoid topical cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Participants having symptomatic hemorrhoids(GRADE 1-4) without need to emergency operation according to physical examination Participants who do not use drugs other than the study drug and the control drug to treat their hemorrhoids during the study period: Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo topical cream 2 cc twice daily for 3 weeks | Drug: placebo topical cream<br>* placebo topical cream 2 cc twice daily for 3 weeks<br>|
| Active Comparator: Anti-hemorrhoid topical cream drug<br>Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week | Drug: Anti-hemorrhoid topical cream<br>* Anti hemorrhoid topical cream 2 cc twice daily for 3 weeks(This cream consists of lidocaine (5% w/w), hydrocortisone acetate (7.5% w/w), aluminium sub-acetate (3.5% w/w), and zinc oxide (18% w/w). 30 g )<br>|
| Active Comparator: Leek topical cream<br>Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks | Drug: Leek topical cream<br>* Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks<br>* Other names: Allium Ampeloprasum Spp.Iranicum topical cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain (visual analogue scale(0-10)) | method of measurement: visual analogue scale(0-10) | 3 weeks | 
| bleeding ( questionnaire) | method of measurement questionnaire:grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe. | 3 weeks | 
| itching ( questionnaire) | method of measurement questionnaire: grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe. | 3 weeks | 
| defecate discomfort (visual analogue scale(0-10) | method of measurement: visual analogue scale(0-10) | 3 weeks | 
| total improvement (visual analogue scale(0-10) | method of measurement:visual analogue scale(0-10) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| constipation (questionnaire) | method of measurement: questionnaire | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhoids, Allium Ampeloprasum, herbal medicine, traditional persian medicine