A Comparative assessment of topical Glucantime® injection plus cryotherapy, and cryotherapy alone for Treatment of Anthroponotic cutaneous leishmaniasis
A Comparative assessment of topical Glucantime® injection plus cryotherapy, and cryotherapy alone for Treatment of Anthroponotic cutaneous leishmaniasis
Design
Two arm parallel group randomised trial with blinded postoperative care.
Out of 476 patients , 276 in the cryotherapy group plus glucantime injection, and 200 in the cryotherapy group alone. The rand function method in Excel software was used for randomization.
Settings and conduct
In the cryotherapy group, the liquid nitrogen from the nitrogen tank is placed around the lesion for 15 to 20 seconds with the help of cotton swabs for a week and the whole area of the lesion is treated in this way. In the cryotherapy and glucantime injections group, in addition to cryotherapy, glucantime ampoules are injected simultaneously into the lesion caused by the disease with an insulin syringe at an angle of 180 degrees. The rand function method in Excel software was used for randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over one year, onset of disease in less than 4 weeks, Exclusion criteria: use of antibiotics or other antimicrobial drugs for leishmaniasis in the past 4 weeks, extensive lesions with a diameter of more than 5 cm and more than 3 lesions on the patient's body.
Intervention groups
Of the 476 patients examined, 276 in the cryotherapy plus Glucantime® injections group and 200 were included in the cryotherapy alone group
Main outcome variables
Diameter size of cutaneous leishmaniasis lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170723035248N4
Registration date:2020-10-09, 1399/07/18
Registration timing:retrospective
Last update:2020-10-09, 1399/07/18
Update count:0
Registration date
2020-10-09, 1399/07/18
Registrant information
Name
Abedin Saghafipour
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3784 2228
Email address
asaghafi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
2013-03-20, 1391/12/30
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-03-18, 1398/12/28
Scientific title
A Comparative assessment of topical Glucantime® injection plus cryotherapy, and cryotherapy alone for Treatment of Anthroponotic cutaneous leishmaniasis
Public title
Comparison of the efficacy of glucantime and cryotherapy simultaneously and cryotherapy alone in the treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for joining the study include age over one year
Onset of disease in less than 4 weeks.
Exclusion criteria:
Criteria for withdrawing from the study include use of antibiotics or other antimicrobial drugs for leishmaniasis in the past 4 weeks
Extensive lesions with a diameter of more than 5 cm and more than 3 lesions on the patient's body.
Age
From 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
476
Actual sample size reached:
476
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, block randomization method will be used for random allocation. The blocks size will be 4 and for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, ِDice drooped and the bloc number will be selected. this procedure continued to completed the allocation and reached to sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of medical Sciences, Bam, Iran
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Abedin Saghafipour
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
No. 17, Mellat St., Behesht Blvd., Pardisan City
City
Qom
Province
Ghoum
Postal code
3711675549
Phone
+98 25 3281 3151
Email
abed.saghafi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Abedin Saghafipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
No. 17, Mellat St., Behesht Blvd., Pardisan Town
City
Ghoum
Province
Ghoum
Postal code
3711675549
Phone
+98 25 3281 3151
Email
abed.saghafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Abedin Saghafipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Pardisan, Behesht Blvd., Mellat St., No. 17
City
Qom
Province
Ghoum
Postal code
3711675549
Phone
+98 25 3281 3151
Email
abed.saghafi@yahoo.com
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
Medical records
When the data will become available and for how long
Access period starts one month after the results are published.
To whom data/document is available
public
Under which criteria data/document could be used
Unconditional.
From where data/document is obtainable
Abedin Saghafipour - Faculty of Health, Qom University of Medical Sciences, Qom, Ruhollah Square, next to the Blood Transfusion Organization, Faculty of Health, Room 16 Phone: 09124397413 Email address: abed.saghafi@yahoo.com
What processes are involved for a request to access data/document