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

Phase 1

• Conditions: Hemorrhoids
• Interventions: Drug: Leek topical cream; Drug: placebo topical cream; Drug: Anti-hemorrhoid topical cream

• Registration Number: NCT02301052
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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

Study Timeline

• Study Start: 2014-09
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-24
• Last Update Submitted: 2014-11-24
• Study First Posted: 2014-11-25
• Last Update Posted: 2014-11-25
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leek topical cream	Leek topical cream	Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
placebo	placebo topical cream	placebo topical cream 2 cc twice daily for 3 weeks
Anti-hemorrhoid topical cream drug	Anti-hemorrhoid topical cream	Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week

Primary Outcome Measures

Name	Time	Method
pain (visual analogue scale(0-10))	3 weeks	method of measurement: visual analogue scale(0-10)
bleeding ( questionnaire)	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)	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)	3 weeks	method of measurement: visual analogue scale(0-10)
total improvement (visual analogue scale(0-10)	3 weeks	method of measurement:visual analogue scale(0-10)

Secondary Outcome Measures

Name	Time	Method
constipation (questionnaire)	3 weeks	method of measurement: questionnaire

Trial Locations

Locations (1)

Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of