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

Primary Purpose

Hemorrhoids

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Leek topical cream
placebo topical cream
Anti-hemorrhoid topical cream
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring hemorrhoids, Allium Ampeloprasum, herbal medicine, traditional persian medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

placebo

Anti-hemorrhoid topical cream drug

Leek topical cream

Arm Description

placebo topical cream 2 cc twice daily for 3 weeks

Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week

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

Outcomes

Primary Outcome Measures

pain (visual analogue scale(0-10))
method of measurement: visual analogue scale(0-10)
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.
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.
defecate discomfort (visual analogue scale(0-10)
method of measurement: visual analogue scale(0-10)
total improvement (visual analogue scale(0-10)
method of measurement:visual analogue scale(0-10)

Secondary Outcome Measures

constipation (questionnaire)
method of measurement: questionnaire

Full Information

First Posted
November 20, 2014
Last Updated
November 24, 2014
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02301052
Brief Title
Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
Official Title
Double Blind Randomized Placebo-control Trial of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
hemorrhoids, Allium Ampeloprasum, herbal medicine, traditional persian medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo topical cream 2 cc twice daily for 3 weeks
Arm Title
Anti-hemorrhoid topical cream drug
Arm Type
Active Comparator
Arm Description
Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week
Arm Title
Leek topical cream
Arm Type
Active Comparator
Arm Description
Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Leek topical cream
Other Intervention Name(s)
Allium Ampeloprasum Spp.Iranicum topical cream
Intervention Description
Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
placebo topical cream
Intervention Description
placebo topical cream 2 cc twice daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Anti-hemorrhoid topical cream
Intervention Description
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 )
Primary Outcome Measure Information:
Title
pain (visual analogue scale(0-10))
Description
method of measurement: visual analogue scale(0-10)
Time Frame
3 weeks
Title
bleeding ( questionnaire)
Description
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
Title
itching ( questionnaire)
Description
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
Title
defecate discomfort (visual analogue scale(0-10)
Description
method of measurement: visual analogue scale(0-10)
Time Frame
3 weeks
Title
total improvement (visual analogue scale(0-10)
Description
method of measurement:visual analogue scale(0-10)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
constipation (questionnaire)
Description
method of measurement: questionnaire
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyed Hamdollah Mosavat, MD
Phone
00987132351087
Email
hamdi_88114@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leyla Ghahramani, Assistant proffessor
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
009871
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyed Hamdollah Mosavat, MD
Email
hamdi_88114@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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