NCT02301052

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

November 20, 2014

Last Update Submit

November 24, 2014

Conditions

Hemorrhoids

Keywords

hemorrhoidsAllium Ampeloprasumherbal medicinetraditional persian medicine

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (1)

  • constipation (questionnaire)

    3 weeks

Study Arms (3)

placebo

PLACEBO COMPARATOR

placebo topical cream 2 cc twice daily for 3 weeks

Drug: placebo topical cream

Anti-hemorrhoid topical cream drug

ACTIVE COMPARATOR

Anti hemorrhoid topical cream as a standard drug 2 cc twice daily for 3 week

Drug: Anti-hemorrhoid topical cream

Leek topical cream

ACTIVE COMPARATOR

Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks

Drug: Leek topical cream

Interventions

Leek topical creamDRUG

Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks

Also known as: Allium Ampeloprasum Spp.Iranicum topical cream
Leek topical cream
placebo topical creamDRUG

placebo topical cream 2 cc twice daily for 3 weeks

placebo
Anti-hemorrhoid topical creamDRUG

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 )

Anti-hemorrhoid topical cream drug

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences

Shiraz, Fars, 009871, Iran

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Leyla Ghahramani, Assistant proffessor

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyed Hamdollah Mosavat, MD

CONTACT

00987132351087hamdi_88114@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shiraz university of medical sciences

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 25, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

IR(1)