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

Shiraz University of Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hemorrhoids

Treatments: Drug: placebo topical cream; Drug: Leek topical cream; Drug: Anti-hemorrhoid topical cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02301052

CT-9377-7127

Details and patient eligibility

About

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

Full 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

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo topical cream 2 cc twice daily for 3 weeks

Treatment:

Drug: placebo topical cream

Anti-hemorrhoid topical cream drug

Active Comparator group

Description:

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

Treatment:

Drug: Anti-hemorrhoid topical cream

Leek topical cream

Active Comparator group

Description:

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

Treatment:

Drug: Leek topical cream