The purpose of this study is to compare the antifungal effect of Punica granatum L. (Pomegranate) peel extract and nystatin against oral candidiasis (oral thrush). In this randomized, double-blind clinical trial, 60 patients with oral candidiasis will be selected of patients who referred to Dermatology Center of Razi Hospital. Identification of oral candidiasis will be confirmed by microscopic morphology and culture. The patients will randomly allocate in two groups of 30 individuals each according to the medication prescribed: Group-I (control group) will use oral nystatin. Group-II (experimental group) will use the P. granatum peel extract as oral gel. Neither the patients nor the physician knows which participants belong to the control group. The oral gel contains pomegranate peel extract will be prepared in Jaber Ebne Hayyan Pharmaceutical Company. All groups use the medicines three times per day for 14 days. After first week and second week the patients will be evaluated for their clinical response and negativity for Candidiasis. Inclusion criteria: The patients who have oral candidiasis. Exclusion criteria: The patients who unable to provide informed consent, individual may not adhere to treatment and individual may not complete follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312161059N2
Registration date:2014-05-11, 1393/02/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-11, 1393/02/21
Registrant information
Name
Shahindokht Bassiri-Jahromi
Name of organization / entity
Pasteur Institute of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 3311
Email address
basiri@pasteur.ac.ir
Recruitment status
Recruitment complete
Funding source
Science Medical Vice chancellor for research, Pasteur Institute of Iran
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pomegranate peel extract anticandidal activity and nystatin in patients with oral candidiasis
Public title
Efficacy evaluation of pomegranate peel extract in oral candidiasis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients who have oral candidiasis. Exclusion criteria: The patients who unable to provide informed consent, may not adhere to treatment or may not complete follow up.
Age
From 1 year old to 100 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This randomized clinical trial will be conducted between 22 May 2014 and 19 February 2015, comparing the effectiveness of pomegranate peel extract and nystatin in patients with oral candidiasis. After assessment of eligibility, sixty subjects will be included in this study. After the initial assessment patients by using the random number tables, will be randomly assigned to either an intervention group or a control-group. After randomization by using the random number tables, the two groups of subjects are followed in exactly the same way.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sciences Ethics committee of Pasteur Institute of Iran
Street address
No. 69,12th Farwardin St., Pasteur St.
City
Tehran
Postal code
1316943551
Approval date
2013-09-10, 1392/06/19
Ethics committee reference number
92/0110/5333
2
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sience, Research institute of Immunology, Asthma &
Street address
No. 62, Dr. Gharib St, Keshavarz Blvd., Immunology, Asthma and Allergy Research Institute, Children's Medical Center, Tehran
City
Tehran
Postal code
14194
Approval date
2011-12-26, 1390/10/05
Ethics committee reference number
371/پ/412
Health conditions studied
1
Description of health condition studied
Oral Candidiasis
ICD-10 code
B 37.0
ICD-10 code description
Candidal stomatitis/Oral thrush
Primary outcomes
1
Description
Presence of fungal infections
Timepoint
before intervention, one week after intervention and end of intervention
Method of measurement
Clinical examinations of oral lesion, fungal laboratory direct and culture examination of oral lesion
Secondary outcomes
1
Description
presence of side effect
Timepoint
One week and two weeks after intervention
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention 1: Pomegranate (Punica granatum L.) peel extract gel. The oral gel contains pomegranate peel extract. It will be prepare in Jaber Ebne Hayyan Pharmaceutical Company in 40 ml tubes and it will be use topical three times per day for 14 days. The combination of carbopol and hydroxypropyl methylcellulose will be used as a gel vehicle for pomegranate peel extract topical application.
Category
Treatment - Drugs
2
Description
Intervention 2: Nystatin
The nystatin level is 1.72% w/w. The combination of carbopol and hydroxypropyl methylcellulose will be used as a gel vehicle for nystatin topical application. It will be prepare in Jaber Ebne Hayyan Pharmaceutical Company in 40 ml tubes and it will be use topical three times per day for 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin centre of Razi Hospital
Full name of responsible person
Dr Amir Hoshang Ehsani
Street address
Vahdat Eslami Sq., Razi Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Science Medical Vice chancellor for research, Pasteur Institute of Iran
Full name of responsible person
Dr. Mohammad Ali Shokrgozar
Street address
No. 69, 12th Farwardin St., Pasteur St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Science Medical Vice chancellor for research, Pasteur Institute of Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Pasteur Institute of Iran
Full name of responsible person
Shahindokht Bassiri-Jahromi
Position
Ph. D student/ Academic member
Other areas of specialty/work
Street address
No.69, 12th Farwardin, Pasteur St. Medical Mycology Department, Pasteur Institute of Iran