A Phase 1/2 interventional study of Leek topical cream and placebo topical cream in Hemorrhoids, sponsored by Shiraz University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-25.
Sponsored by Shiraz University of Medical Sciences · Phase 1/2, Interventional, and Treatment
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
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
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's planned enrollment of 75 is below the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placebo topical cream 2 cc twice daily for 3 weeks
Drug: placebo topical cream
Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week
Drug: Anti-hemorrhoid topical cream
Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
Drug: Leek topical cream
Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
Also known as: Allium Ampeloprasum Spp.Iranicum topical cream
placebo topical cream 2 cc twice daily for 3 weeks
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 )
pain (visual analogue scale(0-10))
method of measurement: visual analogue scale(0-10)
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks
defecate discomfort (visual analogue scale(0-10)
method of measurement: visual analogue scale(0-10)
Time frame: 3 weeks
total improvement (visual analogue scale(0-10)
method of measurement:visual analogue scale(0-10)
Time frame: 3 weeks
constipation (questionnaire)
method of measurement: questionnaire
Time frame: 3 weeks
This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences