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

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02301052
• Other study ID #: CT-9377-7127
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 20, 2014
• Last updated: November 24, 2014
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: Shiraz University of Medical Sciences
• Contact: Seyed Hamdollah Mosavat, MD
• Phone: 00987132351087
• Email: hamdi_88114[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain (visual analogue scale(0-10))	method of measurement: visual analogue scale(0-10)	3 weeks	Yes
Primary	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.	3 weeks	Yes
Primary	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.	3 weeks	Yes
Primary	defecate discomfort (visual analogue scale(0-10)	method of measurement: visual analogue scale(0-10)	3 weeks	Yes
Primary	total improvement (visual analogue scale(0-10)	method of measurement:visual analogue scale(0-10)	3 weeks	Yes
Secondary	constipation (questionnaire)	method of measurement: questionnaire	3 weeks	Yes