Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
Schlüsselwörter
Abstrakt
Beschreibung
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
Termine
| Zuletzt überprüft: | 10/31/2014 |
| Zuerst eingereicht: | 11/19/2014 |
| Geschätzte Einschreibung eingereicht: | 11/23/2014 |
| Zuerst veröffentlicht: | 11/24/2014 |
| Letztes eingereichtes Update: | 11/23/2014 |
| Letztes Update veröffentlicht: | 11/24/2014 |
| Tatsächliches Startdatum der Studie: | 08/31/2014 |
| Geschätztes primäres Abschlussdatum: | 10/31/2014 |
| Voraussichtliches Abschlussdatum der Studie: | 11/30/2014 |
Zustand oder Krankheit
Intervention / Behandlung
Drug: Leek topical cream
Drug: placebo
Drug: Anti-hemorrhoid topical cream drug
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Placebo Comparator: placebo placebo topical cream 2 cc twice daily for 3 weeks | Drug: placebo placebo topical cream 2 cc twice daily for 3 weeks |
| Active Comparator: Anti-hemorrhoid topical cream drug Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week | Drug: 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 ) |
| Active Comparator: Leek topical cream Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks | Drug: Leek topical cream Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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 |
Ergebnis
Primäre Ergebnismaße
1. pain (visual analogue scale(0-10)) [3 weeks]
2. bleeding ( questionnaire) [3 weeks]
3. itching ( questionnaire) [3 weeks]
4. defecate discomfort (visual analogue scale(0-10) [3 weeks]
5. total improvement (visual analogue scale(0-10) [3 weeks]
Sekundäre Ergebnismaße
1. constipation (questionnaire) [3 weeks]
