Hemorrhoids
Conditions
Keywords
hemorrhoids, Allium Ampeloprasum, herbal medicine, traditional persian medicine
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
Interventions
DRUGLeek topical cream
Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
placebo topical cream 2 cc twice daily for 3 weeks
DRUGAnti-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 )
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain (visual analogue scale(0-10)) | 3 weeks | method of measurement: visual analogue scale(0-10) |
| bleeding ( questionnaire) | 3 weeks | method of measurement questionnaire:grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe. |
| itching ( questionnaire) | 3 weeks | method of measurement questionnaire: grade (0-4) that was defined as follow: 0=no symptom, 1= mild, 2=moderate, 3= severe, 4=very severe. |
| defecate discomfort (visual analogue scale(0-10) | 3 weeks | method of measurement: visual analogue scale(0-10) |
| total improvement (visual analogue scale(0-10) | 3 weeks | method of measurement:visual analogue scale(0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| constipation (questionnaire) | 3 weeks | method of measurement: questionnaire |
Countries
Iran
Contacts
Primary ContactSeyed Hamdollah Mosavat, MD
Outcome results
None listed