Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms
Cuvinte cheie
Abstract
Descriere
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
Datele
| Ultima verificare: | 10/31/2014 |
| Primul depus: | 11/19/2014 |
| Inscriere estimată trimisă: | 11/23/2014 |
| Prima postare: | 11/24/2014 |
| Ultima actualizare trimisă: | 11/23/2014 |
| Ultima actualizare postată: | 11/24/2014 |
| Data actuală de începere a studiului: | 08/31/2014 |
| Data estimată de finalizare primară: | 10/31/2014 |
| Data estimată de finalizare a studiului: | 11/30/2014 |
Stare sau boală
Intervenție / tratament
Drug: Leek topical cream
Drug: placebo
Drug: Anti-hemorrhoid topical cream drug
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| 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 |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | All |
| Acceptă voluntari sănătoși | da |
| Criterii | 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 |
Rezultat
Măsuri de rezultate primare
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]
Măsuri de rezultate secundare
1. constipation (questionnaire) [3 weeks]
