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

Shiraz University of Medical Sciences75 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hemorrhoids

Interventions

Leek topical creamDRUG

Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks

placebo topical creamDRUG

placebo topical cream 2 cc twice daily for 3 weeks

Anti-hemorrhoid topical creamDRUG

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 )

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

constipation (questionnaire)

method of measurement: questionnaire

Time frame: 3 weeks

Central Contacts

Seyed Hamdollah Mosavat, MD

CONTACT

00987132351087 hamdi_88114@yahoo.com

Data from ClinicalTrials.gov

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