Comparing the effect of Herbal paste mainly made of Lowsonia inermis, Zataria multiflora and opium, to Glucantime in the treatment of patients with cutaneous Leishmaniasis.
Comparing the effect of Herbal paste mainly made of Lowsonia inermis, Zataria multiflora and opium, to Glucantime in the treatment of patients with cutaneous Leishmaniasis.
Design
Patients are divided into 50 persons on the basis of the date of entry.Patients are unaware of the treatment and they will be treated in two separate centers.
Settings and conduct
Study will be done in Fars Province, which is an endemic area of cutaneous leishmaniasis.It will be done in two centers of the city of Shiraz and Karamah and Coordinated with the health department.
Participants/Inclusion and exclusion criteria
Confirmation of CL based on positive smear
culture positive from lesion
PCR positive
less than 70years
not getting any medication.
ٍExclution:
Pregnant women
Mother feeding their babies
Using immunodeficient drugs from three months ago
using any treatment for leishmaniasis
Intervention groups
They will divided in two groups:The first group(control), will treated with glucantime according to the standard, The second group(intervention), will treated with the topical herbal paste of Lowsonia inermis and Zataria multiflora for same duration.
Main outcome variables
Decreased inflammation, shrinkage of the wound, absence of parasite in the wound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150105020570N3
Registration date:2018-06-18, 1397/03/28
Registration timing:registered_while_recruiting
Last update:2018-06-18, 1397/03/28
Update count:0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5291
Email address
motazedm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2018-09-16, 1397/06/25
Actual recruitment start date
2018-05-10, 1397/02/20
Actual recruitment end date
2018-09-16, 1397/06/25
Trial completion date
empty
Scientific title
Comparing the effect of Herbal paste mainly made of Lowsonia inermis, Zataria multiflora and opium, to Glucantime in the treatment of patients with cutaneous Leishmaniasis.
Public title
Evaluation of Lowsonia inermis (Henna) and Zataria multiflora (Shirazi thyme) in treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
confirmation of CL based on positive smear
culture positive from lesion
PCR positive
Under 70 years old
Exclusion criteria:
pregnant women
mother feeding their babies
using immunodeficient drugs from three months ago
using any treatment for leishmaniasis
Age
To 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided in two A and B groups according to their alphabetic names.
Blinding (investigator's opinion)
Double blinded
Blinding description
1.individuals who received the treatment.
2.analyzer of data who examine the patients after three months and evaluate the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medial Sciences
Street address
Shiraz Blv Zand
City
Shiraz-
Province
Fars
Postal code
7134845794
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
IR.SUMS.REC.1394,79
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
Decreased inflammation, shrinkage of the wound, absence of parasite in the wound
Timepoint
14 days,45days ,3 month
Method of measurement
Observation and measure of the lesion
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Pour the ointment prepared from the mixture of henna and Shirazy thyme once a day for 14 days.
Category
N/A
2
Description
Control group: This group receives the glucantime drug used in the treatment of the disease in standard form
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
kharameh Health and tretment Center
Full name of responsible person
Moghadami Mohsen
Street address
Shiraz Zand Blv
City
Shiraz- kharameh
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5291
Fax
+98 71 3230 5291
Email
motazedm@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran.
Full name of responsible person
Basir Hashemi
Street address
Vice Chancellar of Research Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz Kharameh
Province
Fars
Postal code
7134845794
Phone
+98 71 3212 2389
Email
motazedm@sums.ac.ir
Grant name
Grant code / Reference number
94-7547
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Shiraz, Iran.
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
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Motazedian
Position
PhD of Parasitology , Mycology
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5291
Fax
Email
motazedm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Motazedian
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Shiraz University of Medical Sciences Zand Blv
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5291
Fax
Email
motazedm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Motazedian
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Zand Blv
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5291
Email
motazedm@sums.ac.ir
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 total potential data can be shared after unidentifiable people
When the data will become available and for how long
After registering the drug and printing the article.
To whom data/document is available
Only for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Analyzed data is available.
From where data/document is obtainable
Refer to the author for reference.
What processes are involved for a request to access data/document