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

November 24, 2014 updated by: Leyla Ghahramani, Shiraz University of Medical Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of, 009871
        • Recruiting
        • Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo topical cream 2 cc twice daily for 3 weeks
Drug: placebo topical cream
placebo topical cream 2 cc twice daily for 3 weeks
Active Comparator: Anti-hemorrhoid topical cream drug
Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week
Drug: Anti-hemorrhoid topical cream
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 )
Active Comparator: Leek 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
Other Names:
  • Allium Ampeloprasum Spp.Iranicum topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain (visual analogue scale(0-10))
Time Frame: 3 weeks
method of measurement: visual analogue scale(0-10)
3 weeks
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.
3 weeks
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.
3 weeks
defecate discomfort (visual analogue scale(0-10)
Time Frame: 3 weeks
method of measurement: visual analogue scale(0-10)
3 weeks
total improvement (visual analogue scale(0-10)
Time Frame: 3 weeks
method of measurement:visual analogue scale(0-10)
3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Principal Investigator: Leyla Ghahramani, Assistant proffessor, shiraz University of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-9377-7127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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