Protocol summary
-
Study aim
-
Determination of the efficacy of cryotherapy plus topical Juniperus excelsa M.Bieb, based on traditional Persian medicine, versus cryotherapy alone in the treatment of cutaneous leishmaniasis
-
Design
-
Two arm parallel group randomised clinical trial, triple-blinded
-
Settings and conduct
-
Design of the study: Patients with cutaneous leishmaniasis lesions referring to Shohaday-e- Enghelab Health Center of Shiraz and Shahid Faghihi Dermatology Clinic. In order to blind the researcher, medications are named as "A" for 5% Juniperus excelsa M.Bieb cream and B for placebo. The patient don't aware of the type of drug he/she is assigned to. In addition, the groups are entered into statistical analysis as "A" and "B".
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: 1- Age 18 to 70 years the maximum 2- The maximum duration of their involvement by leishmaniasis is 4 months 3-Having physical health except the cutaneous leishmaniasis infection 4- Having 4 or less of the lesion leishmaniasis lesions 5-Did not taking any of topical and systemic anti-Leishmania treatment during last 4 weeks 6-Cutaneous leishmaniasis is approved of by smear**** Exclusion criteria: 1-Patients with complex forms of leishmaniasis and symptoms of mucousal leishmaniasis 2-Having more than 4 lesions 3- The lesions greater than 5 cm 4- Sub-cutaneous nodules 5-Regional adenopaty if greater than 1 cm size 6-Patients with immunodeficiency disease 7-The infants and children less than 18 years 8-Women in lactation and pregnancy 9-Patients with satellite lesions or sporotrichoid lesions 10-Patients with facial cutaneous leishmaniasis lesions
-
Intervention groups
-
Group A: Use of topical product (5% extract of Juniperus excelsa M.Bieb leaf cream) on cutaneous leishmaniasis lesions, 3 times daily
Group B: Use of Placebo cutaneous leishmaniasis lesions, 3 times daily
-
Main outcome variables
-
The area of the cutaneous leishmaniasis lesions of the patients
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2015082523753N1
Registration date:
2015-09-05, 1394/06/14
Registration timing:
prospective
Last update:
2018-02-17, 1396/11/28
Update count:
1
-
Registration date
-
2015-09-05, 1394/06/14
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor of Research, Shiraz University of Medical Sciences
-
Expected recruitment start date
-
2015-10-07, 1394/07/15
-
Expected recruitment end date
-
2016-03-20, 1395/01/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Determination of the efficacy of cryotherapy plus topical Juniperus excelsa M.Bieb, based on traditional Persian medicine, versus cryotherapy alone in the treatment of cutaneous leishmaniasis: a double-blind randomized clinical trial
-
Public title
-
Effectiveness of traditional medicine products Juniperus excelsa M.Bieb in the treatment of cutaneous leishmaniasis
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age 18 to 70 years the maximum
The maximum duration of their involvement by leishmaniasis is 4 months
Having physical health except the cutaneous leishmaniasis infection
Having 4 or less of the lesion leishmaniasis lesions
Did not taking any of topical and systemic anti-Leishmania treatment during last 4 weeks
Cutaneous leishmaniasis is approved of by smear
Exclusion criteria:
Patients with complex forms of leishmaniasis and symptoms of mucousal leishmaniasis
Having more than 4 lesions
The lesions greater than 5 cm
Sub-cutaneous nodules
Regional adenopaty if greater than 1 cm size
Patients with immunodeficiency disease
The infants and children less than 18 years
Women in lactation and pregnancy
Patients with satellite lesions or sporotrichoid lesions
Patients with facial cutaneous leishmaniasis lesions
-
Age
-
From 18 years old to 70 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Data analyser
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Random allocation software Ink was used to create a randomization table
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
In order to blind the investigator, medications are named A (Juniperus excelsa) and B (Placebo). The patient are not considered the type of drug are assigned to. The groups are also coded A and B for statistical analyzes.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
invivo and invitro phase of the study has been completed and now this study is carried out the effects of drugs on humans, .
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2015-08-23, 1394/06/01
-
Ethics committee reference number
-
IR.SUMS.REC.1394.91
Health conditions studied
1
-
Description of health condition studied
-
cutaneous leishmaniasis
-
ICD-10 code
-
B55.1
-
ICD-10 code description
-
Cutaneous leishmaniasis
Primary outcomes
1
-
Description
-
size and area of leishmaniasis lesion
-
Timepoint
-
previous of the starting the treatment, weekly in the first month of treatment and every two weeks from second month to the end of the study
-
Method of measurement
-
Cooley and math with the square millimeters
Secondary outcomes
1
-
Description
-
Duration of the healing the lesion
-
Timepoint
-
At the end of the treatment proccess
-
Method of measurement
-
The time interval between the beginning and end of treatment in days
Intervention groups
1
-
Description
-
Intervention group: cryotherapy as a standard treatment in addition to cream (topical pharmaceutical products) containing 5% extract of Juniperus excelsa M.Bieb adminnistrate, three times daily for 12 weeks.
-
Category
-
Treatment - Drugs
2
-
Description
-
control group: cryotherapy as a standard treatment in addition to topical placebo cream with drug-like compounds and color with the exception of Juniperus excelsa M.Bieb extract, administrate every 8 hours daily for 12 weeks.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
محل پرداخت قراردادهای دانشگاه علوم پزشکی شیراز
-
Grant code / Reference number
-
94-7556
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Shiraz University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
The charasrristic of the patients participating in the study is reported in the published article.
-
When the data will become available and for how long
-
The documentation had been published on PLOS Neglected Tropical Diseases journal's website .
-
To whom data/document is available
-
All of the researchers
-
Under which criteria data/document could be used
-
Provided that cite to the article if thedata and results of this study are used
-
From where data/document is obtainable
-
PLOS Neglected Tropical Diseases journal's website
-
What processes are involved for a request to access data/document
-
visit the PLOS Neglected Tropical Diseases journal's website and also sending a request via the email to the researchers
-
Comments
-