Determining the therapeutic effect of Shirvan herbal ointment compared to glucantim drug on the cutaneous leshmaniasis wounds.
Design
The clinical trial has a control group, with parallel groups, no blind strain, no randomization, phase 3 on 10 patients.
Settings and conduct
The location of the research is the Skin Disease Research Center of Isfahan University of Medical Sciences.
In the case of 10 patients with at least two lesions less than 2 cm, Shirvan herbal ointment (twice a day) for one lesion and glucantim drug (5 ml intralesional injection weekly up to a maximum of 6 times (42 days)) for the other lesion will be used. At each follow-up, the size of erythema, induration, ulceration and scar (the largest diameter times its perpendicular diameter in milliliters) will be recorded. Evaluation of clinical improvement based on complete re-epithelialization of lesions as the main measure of treatment effect, in the last injection session and follow-up period (1, 4 weeks and 6 months) will be performed on each of the treated lesions.
Participants/Inclusion and exclusion criteria
1.Confirmed cases of urban leishmaniasis.
2.Informed consent signed
3.Lesions < 2 cm in diameter,
4.Lesions only in the hands and feet.
Intervention groups
In the case of 10 patients with a minimum lesion of less than 2 cm, Shirvan herbal ointment (twice a day) for one lesion and glucantim drug (intralesional injection of 5 ml weekly up to a maximum of 6 times (42 days)) will be used for the other lesion.
Main outcome variables
Re-epithelialization of lesions, Reducing the average healing time of lesions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230621058552N1
Registration date:2023-06-28, 1402/04/07
Registration timing:prospective
Last update:2023-06-28, 1402/04/07
Update count:0
Registration date
2023-06-28, 1402/04/07
Registrant information
Name
maryam aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 2206
Email address
maryam.aghaei2008@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effect of Shirvan herbal ointment with glucantim drug on the cutaneous leshmaniasis wounds.
Public title
Comparison the effect of Shirvan herbal ointment and glucantim drug on the cutaneous leshmaniasis wounds.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed cases of urban leishmaniasis.
Informed consent signed
The diameter of the lesion < 2 cm.
Lesions only in hands and feet.
Exclusion criteria:
Pregnant or lactating women,
Cardiovascular patients,
Lesions on joints and cartilage,
The diameter of the lesions> 2 cm,
Illness period of more than 8 weeks,
Sperotrichoid and chronic lesions,
Using any type of treatment for leishmaniasis in the last month.
Participation in any type of project in the last 2 months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
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 Isfahan University of Medical Sciences
Street address
Hezar Jarib Street . Azadi Square.
City
Isfahan
Province
Isfehan
Postal code
8173963181
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.ARI.MUI.REC.1401.339
Health conditions studied
1
Description of health condition studied
Leishmaniasis
ICD-10 code
Z68.53
ICD-10 code description
Body mass index (BMI) pediatric, 85th percentile to less than 95th percentile for age
Primary outcomes
1
Description
At each follow-up, the size of erythema, induration, ulceration and scar (largest diameter times its perpendicular diameter in milliliters) will be recorded. Evaluation of clinical recovery based on the complete re-epithelialization of the lesions as the main measure of treatment effect is performed in the last injection session and the follow-up period (1, 4 weeks and 6 months) on each of the treated lesions.
Timepoint
The measurement of the lesion is at the beginning of the study (before the start of the intervention) and 1, 4 weeks and 6 months after the start of taking Shirvan herbal ointment and glucantim medicine.
Method of measurement
The lesion surface will be measured using caliper software.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the case of 10 patients with a minimum lesion of less than 2 cm, Shirvan herbal ointment (twice a day) for one lesion and glucantim drug (intralesional injection of 5 ml weekly up to a maximum of 6 times (42 days)) will be used for the other lesion.