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

NCT ID: NCT02301052

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

placebo topical cream 2 cc twice daily for 3 weeks

Group Type PLACEBO_COMPARATOR

placebo topical cream

Intervention Type DRUG

placebo topical cream 2 cc twice daily for 3 weeks

Anti-hemorrhoid topical cream drug

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

Group Type ACTIVE_COMPARATOR

Anti-hemorrhoid topical cream

Intervention Type DRUG

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 )

Leek topical cream

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

Group Type ACTIVE_COMPARATOR

Leek topical cream

Intervention Type DRUG

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

Interventions

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Leek topical cream

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

Intervention Type DRUG

placebo topical cream

placebo topical cream 2 cc twice daily for 3 weeks

Intervention Type 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 )

Intervention Type DRUG

Other Intervention Names

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Allium Ampeloprasum Spp.Iranicum topical cream

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leyla Ghahramani

Shiraz university of medical sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leyla Ghahramani, Assistant proffessor

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Locations

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

Shiraz, Fars, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Seyed Hamdollah Mosavat, MD

Role: CONTACT

[email protected]
00987132351087

Facility Contacts

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Seyed Hamdollah Mosavat, MD

Role: primary

[email protected]

Other Identifiers

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CT-9377-7127

Identifier Type: -

Identifier Source: org_study_id