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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02301052
• Date of registration: 20/11/2014
• Prospective Registration: No
• Primary sponsor: Shiraz University of Medical Sciences
• Public title: Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
• Scientific title: Double Blind Randomized Placebo-control Trial of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
• Date of first enrolment: September 2014
• Target sample size: 75
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02301052
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Iran, Islamic Republic of

Contacts

• Name: Seyed Hamdollah Mosavat, MD

• Name: Leyla Ghahramani, Assistant proffessor
• Affiliation: Shiraz University of Medical Sciences

• Name: Seyed Hamdollah Mosavat, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hemorrhoids

Intervention(s)

Drug: Leek topical cream

Drug: Anti-hemorrhoid topical cream

Drug: placebo topical cream

Primary Outcome(s)

total improvement (visual analogue scale(0-10) [Time Frame: 3 weeks]

defecate discomfort (visual analogue scale(0-10) [Time Frame: 3 weeks]

bleeding ( questionnaire) [Time Frame: 3 weeks]

pain (visual analogue scale(0-10)) [Time Frame: 3 weeks]

itching ( questionnaire) [Time Frame: 3 weeks]

Secondary Outcome(s)

constipation (questionnaire) [Time Frame: 3 weeks]

Secondary ID(s)

CT-9377-7127

Source(s) of Monetary Support

Please refer to primary and secondary sponsors