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

Acronym
IRCT registration number

IRCT registration number: IRCT2015082523753N1
Date registered: September 5, 2015
Registration timing: Prospective registration

Recruitment status
Recruitment complete
Expected recruitment start date
2015-10-07
Expected recruitment end date
2016-03-20
Funding source
Vice chancellor of Research, Shiraz University of Medical Sciences
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
Summary
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.
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
Gender
Both male and female
Condition studied 1
cutaneous leishmaniasis
Condition code
B55.1
ICD chapter code
Cutaneous leishmaniasis
Intervention/Control 1
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.
Intervention category
Treatment: drugs
Intervention/Control 2
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.
Intervention category
Placebo
Primary outcome measure 1
size and area of leishmaniasis lesion
Primary outcome time point
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
Primary outcome method of measurement
Cooley and math with the square millimeters
Secondary outcome measure 1
Duration of the healing the lesion
Secondary outcome time point
At the end of the treatment proccess
Secondary outcome method of measurement
The time interval between the beginning and end of treatment in days
Trial phase
3
Target sample size
60
Randomization
randomized
Blinding
Double blind
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, .
Centre name 1
Dermatology clinic of Shahid Faghihi hospital
Contact person's name
Mohammad Mahdi Parvizi, MD, PHD
Country
Iran, Islamic Republic Of
Contact details

Shahid Faghihi hospital, Zand blv., Shiraz, Fars, Iran
Shiraz
Fars

00987132305410
00989173237031
00
mmparvizi@gmail.com; parvizim@sums.ac.ir

Centre name 2
Imam Reza Subspecialty Clinic
Contact person's name
Mohammad Mahdi Parvizi, MD, PHD
Country
Iran, Islamic Republic Of
Contact details

Imam Reza Subspecialty Clinic, Zand blv., Nemazee Square Shiraz, Fars, Iran
Shiraz
Fars
71348714737
00987132127244
00
00

Ethics committee name
Ethics committee of Shiraz University of Medical Sciences
Date approved
2015-08-23
Reference number
IR.SUMS.REC.1394.91
Contact details

Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran
Shiraz
Fars
Iran, Islamic Republic Of
14336 - 71348

Sponsor
vice chancellor for research of shiraz university of medical science
Contact person's name
Seyd Basir Hashemi, MD
Grant name
Locality pay contracts, Shiraz university of medical science
Contact details

7th floor,Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
Shiraz
Fars
Iran, Islamic Republic Of
713451978
00987132357282
00
00987132122430
hashemib@sums.ac.ir; hashemib@yahoo.com
research.sums.ac.ir

Person responsible for general inquiries
Dr. Mohammad Mahdi Parvizi
Affiliated Organization name
Shiraz University of Medical Science, School of Traditional Medicine, Shiraz, Iran
Position/degree
PHD Student of traditional Persian medicine
Contact details

7th floor, building No.2, School of Medical Science, Zand blv, Shiraz, Fars, Iran
Shiraz
Fars
Iran, Islamic Republic Of
7134845794
00987132347966
00989173237031

parvizim@sums.ac.ir; mmparvizi@gmail.com

Person responsible for scientific inquiries
Dr. Farhad Handjani,
Affiliated Organization name
Shiraz University of Medical Science, Dermatology Department, Shiraz, Iran
Position / degree
Professeur agrégé of Dermatology
Contact details

Dermatology department of Shahid Faghihi Hospital, Zand blv. Shiraz, Fars, Iran
Shiraz
Fars
Iran, Islamic Republic Of

00987132319049
00989171112150

hanjanif@yahoo.com; hanjanif@sums.ac.ir

Person responsible for updating data
Dr. Mohammad Mahdi Parvizi
Affiliated Organization name
Shiraz University of Medical Science, School of Traditional Medicine, Shiraz, Iran
Position / degree
PHD Student of traditional Persian medicine
Contact details

7th floor, building No.2, School of Medical Science, Zand blv, Shiraz, Fars, Iran
Shiraz
Fars
Iran, Islamic Republic Of

00987132347966
00989173237031

parvizim@sums.ac.ir; mmparvizi@gmail.com

Registered by

Mohammad Mahdi Parvizi
Shiraz University of Medical Sciences, Traditional medicine school, Shiraz, Iran
Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran
Shiraz
Fars
Iran, Islamic Republic Of
00987132305410
00987132122991
parvizim@sums.ac.ir