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
Objectives: Leishmaniasis refers to a set of diseases caused by intracellular protozoan of the genus Leishmania. The disease is divided into three clinical categories, including cutaneous leishmaniasis, mucous leishmaniasis and visceral leishmaniasis. Content written about this disease in the context of traditional medicine is a clear indication of skin and mucocutaneous form of the disease. Many drugs are cited in traditional medicine to treat and cure it by different physicians. In this study, used topical products of leaves of Juniperus excelsa M.Bieb for the treatment of leishmaniasis.
Design: Randomized, double-blind, placebo-controlled, multiple-center, phase three of trials
Setting and conduct: Patients with cutaneous leishmaniasis reffer to dermatology clinics of Imam Reza and Shahid Faghihi.
Major Inclusion criteria: patients 18 to 70 years who have cutaneous lesions are a maximum of 4.
Major Exclusion criteria: severe disease; children under than 18 years of age and patient with complications.
Sample size: 60
Intervention: Case group, receive topical products of Juniperus in addition to cryotherapy, and patients in control group receive placebo-up in addition to cryotherapy
Main variables and outcome measures Assessment of the size and area will be done before of the treatment, weekly in the first month of treatment and every two weeks from second month to the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082523753N1
Registration date:2015-09-05, 1394/06/14
Registration timing:prospective
Last update:
Update count:1
Registration date
2015-09-05, 1394/06/14
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
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 4 months past from their involvement in leishmaniasis; Having physical health except the cutaneous leishmaniasis infection; Having 4 or less of the lesion leishmaniasis lesions; no treatment of topical and systemic anti-Leishmania common drugs during the last 4 weeks; and is proof of cutaneous leishmaniasis by smear**** Exclusion criteria: complex and with duties that include patient has symptoms of leishmaniasis mucous; more than 4 lesions; lesions greater than 5 cm; nodules under the skin; cervical region with a size greater than 1 cm; those with immunodeficiency and leishmaniasis lesions in the patient's facial; the infants and children less than 18 years; women in lactation and pregnancy; satellite lesions or sporotrichoid lesions
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
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
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, .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran
City
Shiraz
Postal code
14336 - 71348
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.