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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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
Sponsor: Shiraz University of Medical Sciences

Current Primary Outcome:

  • pain (visual analogue scale(0-10)) [ Time Frame: 3 weeks ]
    method of measurement: visual analogue scale(0-10)
  • bleeding ( questionnaire) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 3 weeks ]
    method of measurement: visual analogue scale(0-10)
  • total improvement (visual analogue scale(0-10) [ Time Frame: 3 weeks ]
    method of measurement:visual analogue scale(0-10)


Original Primary Outcome: Same as current

Current Secondary Outcome: constipation (questionnaire) [ Time Frame: 3 weeks ]

method of measurement: questionnaire


Original Secondary Outcome: Same as current

Information By: Shiraz University of Medical Sciences

Dates:
Date Received: November 20, 2014
Date Started: September 2014
Date Completion: December 2014
Last Updated: November 24, 2014
Last Verified: November 2014