Clinical trial NCT02301052: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hemorrhoids
Keywords: hemorrhoids
Allium Ampeloprasum
herbal medicine
traditional persian medicine
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: pain (visual analogue scale(0-10))
timeFrame: 3 weeks
measure: bleeding ( questionnaire)
timeFrame: 3 weeks
measure: itching ( questionnaire)
timeFrame: 3 weeks
measure: defecate discomfort (visual analogue scale(0-10)
timeFrame: 3 weeks
measure: total improvement (visual analogue scale(0-10)
timeFrame: 3 weeks
Secondary outcomes:
measure: constipation (questionnaire)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Leyla Ghahramani, Assistant proffessor
role: PRINCIPAL_INVESTIGATOR
References: