Comparison of efficacy of infrared heat therapy with cryotherapy as an adjunct to meglumine antimoniate in treatment of cutaneous leishmaniasis
Design
Clinical trial which is a parallel group,double blind, randomised, phase 3 trial
Settings and conduct
Dermatology department Combined military hospital Quetta
Participants/Inclusion and exclusion criteria
Inclusion criteria includes 18 years or older, diagnosis confirmed with biopsy and smear ,caused by leishmania species amenable to treatment with meglumine
Exclusion criteria involves individuals with comorbidities, pregnant women, abnormal ECG, allergy to antimonials, compromised immune system, diffuse or visceral leishmaniasis,
Intervention groups
Patient,researcher and outcome assessor studying three groups ,group 1,group 2 and group 3.Group 1 receiving infrared heat therapy twice a week 2 cycles of 10 mins session with gap of 2 minutesand meglumine antimoniate group 2 receiving cryotherapy twice a week with cryogun/cotton wisp applied on lesion unless appears white and meglumine antimoniate and group 3 receiving meglumine antimoniate alone
Main outcome variables
Clinical response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210823052264N5
Registration date:2024-05-18, 1403/02/29
Registration timing:registered_while_recruiting
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-16, 1403/02/27
Expected recruitment end date
2024-06-06, 1403/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of infrared heat therapy with cryotherapy as an adjunct to meglumine antimoniate in treatment of cutaneous leishmaniasis
Public title
Comparison of efficacy of infrared heat therapy with cryotherapy as an adjunct to meglumine antimoniate in treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years or older
Lesion size 4cm or more
Multiple lesion
Lesion that will have difficulty in healing like on lower limb or over joint
Biopsy proven cutaneous leishmaniasis
Exclusion criteria:
Patients with comorbidities(diabetes mellitus, hypertension, chronic kidney disease
Abnormal ECG/heart disease
Photosensitivity
Pregnant women
Individuals with compromised immune systems
Diffuse cutaneous or visceral leishmaniasis
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomisation by lottery method in which treatment methods were written on chits and placed in jar and each patient would pick up a chit and would follow that treatment
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind technique is used where patient and data analyzer doesn't know only researcher knows about treatment methods
Cutaneous leishmaniasis is a skin disease caused by parasite leishmania major and leishmania tropica in Pakistan province balochistan
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Lesion complete healing with negative induration,ulceration,oozing,sporotrichoid distribution in response to treatment
Timepoint
Before intervention and 2,6,4,8 weeks after intervention until complete healing occur then patient called for follow up after 4 weeks
Method of measurement
Clinical response evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 receiving infrared heat therapy twice a week 2 cycles for 10 minutes with gap of 2 mins at a distance of 4cm and achieving temperature of 45 degree Celsius with meglumine antimoniate
Category
Treatment - Drugs
2
Description
Intervention group 2 receiving cryotherapy twice a week with cryogun/cotton wisp dipped in liquid nitrogen until lesion turns white and meglumine antimoniate
Category
Treatment - Drugs
3
Description
Intervention group 3 receiving only meglumine antimoniate injection 15mg/kg IM/IV
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined military hospital Quetta
Full name of responsible person
Dr Zainab Kazam
Street address
Combined military hospital Quetta
City
Quetta
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined military hospital Quetta
Full name of responsible person
Dr Zainab kazam
Street address
Combined military hospital Quetta
City
Quetta
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Grant name
Combined military hospital Quetta
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined military hospital Quetta
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
Sponsor: country of origin
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Combined military hospital Quetta
Full name of responsible person
Dr Zainab Kazam
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Combined military hospital Quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined military hospital Quetta
Full name of responsible person
Dr Zainab Kazam
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Combined military hospital Quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined military hospital Quetta
Full name of responsible person
Dr Zainab kazam
Position
Registrar dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Combined military hospital quetta
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 336 5534909
Email
zainokazam@gmail.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
Comparison of efficacy of infrared heat therapy with cryotherapy as an adjunct to meglumine antimoniate in treatment of cutaneous leishmaniasis
Primary outcome
When the data will become available and for how long
One month after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Many
From where data/document is obtainable
zainokazam@gmail.com
What processes are involved for a request to access data/document