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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo topical cream 2 cc twice daily for 3 weeks |
|
| Anti-hemorrhoid topical cream drug | Active Comparator | Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week |
|
| Leek topical cream | Active Comparator | Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leek topical cream | Drug | Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain (visual analogue scale(0-10)) | method of measurement: visual analogue scale(0-10) | 3 weeks |
| 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 |
| 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 |
| defecate discomfort (visual analogue scale(0-10) | method of measurement: visual analogue scale(0-10) | 3 weeks |
| total improvement (visual analogue scale(0-10) | method of measurement:visual analogue scale(0-10) | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| constipation (questionnaire) | method of measurement: questionnaire | 3 weeks |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyed Hamdollah Mosavat, MD | Contact | 00987132351087 | hamdi_88114@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Leyla Ghahramani, Assistant proffessor | Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences | Recruiting | Shiraz | Fars | 009871 | Iran |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 18, 2020 | |
| Reset | Aug 4, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 18, 2020 | Aug 4, 2020 |
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| placebo topical cream | Drug | placebo topical cream 2 cc twice daily for 3 weeks |
|
| Anti-hemorrhoid topical cream | Drug | 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 ) |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |