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Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Leyla Ghahramani, Shiraz University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02301052
First Posted: November 25, 2014
Last Update Posted: November 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Leyla Ghahramani, Shiraz University of Medical Sciences
  Purpose
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

Condition Intervention Phase
Hemorrhoids Drug: Leek topical cream Drug: placebo topical cream Drug: Anti-hemorrhoid topical cream Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Randomized Placebo-control Trial of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms

Resource links provided by NLM:


Further study details as provided by Leyla Ghahramani, Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • pain (visual analogue scale(0-10)) [ Time Frame: 3 weeks ]
    method of measurement: visual analogue scale(0-10)

  • bleeding ( questionnaire) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 3 weeks ]
    method of measurement: visual analogue scale(0-10)

  • total improvement (visual analogue scale(0-10) [ Time Frame: 3 weeks ]
    method of measurement:visual analogue scale(0-10)


Secondary Outcome Measures:
  • constipation (questionnaire) [ Time Frame: 3 weeks ]
    method of measurement: questionnaire


Estimated Enrollment: 75
Study Start Date: September 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo topical cream 2 cc twice daily for 3 weeks
Drug: placebo topical cream
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
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
Other Name: Allium Ampeloprasum Spp.Iranicum topical cream

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301052


Contacts
Contact: Seyed Hamdollah Mosavat, MD 00987132351087 hamdi_88114@yahoo.com

Locations
Iran, Islamic Republic of
Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences Recruiting
Shiraz, Fars, Iran, Islamic Republic of, 009871
Contact: Seyed Hamdollah Mosavat, MD       hamdi_88114@yahoo.com   
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Principal Investigator: Leyla Ghahramani, Assistant proffessor Shiraz University of Medical Sciences
  More Information

Responsible Party: Leyla Ghahramani, Shiraz university of medical sciences, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02301052     History of Changes
Other Study ID Numbers: CT-9377-7127
First Submitted: November 20, 2014
First Posted: November 25, 2014
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Leyla Ghahramani, Shiraz University of Medical Sciences:
hemorrhoids
Allium Ampeloprasum
herbal medicine
traditional persian medicine

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases