Protocol summary
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Study aim
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Determining the therapeutic effect of Shirvan herbal ointment compared to glucantim drug on the cutaneous leshmaniasis wounds.
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Design
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The clinical trial has a control group, with parallel groups, no blind strain, no randomization, phase 3 on 10 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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1.Confirmed cases of urban leishmaniasis.
2.Informed consent signed
3.Lesions < 2 cm in diameter,
4.Lesions only in the hands and feet.
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Intervention groups
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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.
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Main outcome variables
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Re-epithelialization of lesions, Reducing the average healing time of lesions.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230621058552N1
Registration date:
2023-06-28, 1402/04/07
Registration timing:
prospective
Last update:
2026-07-02, 1405/04/11
Update count:
1
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Registration date
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2023-06-28, 1402/04/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-08-23, 1402/06/01
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Expected recruitment end date
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2023-12-22, 1402/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison the therapeutic effect of Shirvan herbal ointment with glucantim drug on the cutaneous leshmaniasis wounds.
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Public title
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Comparison the effect of Shirvan herbal ointment and glucantim drug on the cutaneous leshmaniasis wounds.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
10
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-14, 1401/12/23
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Ethics committee reference number
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IR.ARI.MUI.REC.1401.339
Health conditions studied
1
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Description of health condition studied
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Leishmaniasis
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ICD-10 code
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Z68.53
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ICD-10 code description
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Body mass index (BMI) pediatric, 85th percentile to less than 95th percentile for age
Primary outcomes
1
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Description
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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.
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Timepoint
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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.
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Method of measurement
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The lesion surface will be measured using caliper software.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2026-07-02, 1405/04/11
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Table of baseline comparison
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|
Test(n=30) |
Control(n=30) |
P |
| Age (years) |
26.9±13.3 |
33.16±12.80 |
0.07 |
| Mean number of lesions (±SD) |
1.8±1.1 |
2.1±1.1 |
0.265 |
| Mean duration of treatment (day) |
30.5±7.4 |
43.9±14.4 |
0.00 |
| Mean lesion location (upper limbs) |
0.9±0.92 |
0.8±0.84 |
0.66 |
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Participant flow diagram
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Table of variable outcomes' results
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| Week |
Test (n=30) |
Control (n=30) |
P |
| Before treatment |
50.8±31.2 |
51.5±32.5 |
0.93 |
| First week |
40.9±26.4 |
45.9±31.1 |
0.5 |
| Second week |
30.1±21.4 |
40.1±29.2 |
0.139 |
| Third week |
19.3±18.0 |
31.3±25.8 |
0.04 |
| Fourth week |
9.2±11.7 |
23.6±22.4 |
0.003 |
| Fifth week |
3.8±6.9 |
17.6±19.6 |
0.001 |
| Sixth week |
0.92±2.3 |
12.6±15.7 |
0.00 |
| Seventh week |
0.00±0.00 |
11.5±16.1 |
0.00 |
| Eighth week |
0.00±0.00 |
11.1±16.2 |
0.00 |
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Table of adverse events
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First publication date
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2024-08-26, 1403/06/05
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Abstract of published paper
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Background: Cutaneous leishmaniasis (CL) infection is caused by the Leishmania major (L. major) parasite and affects 1.5 to 2 million people worldwide each year. Although research into vaccines and antiparasitic drugs has been somewhat successful, their adverse effects include high toxicity, prolonged regeneration, and scarring. This has highlighted the importance of research to replace natural products with antibacterial and antioxidant properties, such as vegetable extracts and oils.Since, the anti‑leishmaniasis effect of each of the components of Shirvan herbal ointment (aloe vera, Brazembel, Nigella sativa, propolis, lavender, and olive oil) has been separately studied and confirmed, it seems that the combination of these components can have an increasing anti‑leishmanial effect to treat CL. Therefore, this study investigated the therapeutic impact of Shirvan herbal ointment on Iranian patients with leishmaniasis in comparison with glucantime (meglumine).
Materials and Methods: Sixty patients with leishmaniasis were divided into the control and test groups. The control and test groups received intralesional glucantime and Shirvan herbal cream (two times daily), respectively.
Results: The size mean of the lesion was 51.5 ± 32.5 before and 11.11 ± 16.28 after treatment in the control group and 50.8 ± 31.2 before and 0.0 ± 0.0 after treatment in the test group. In addition, the period mean of treatment was 43.9 ± 14.4 days and 30.5 ± 7.4 days in the control and test groups, respectively. There was a significant difference in lesion size between the two groups after treatment.
Conclusion: Data suggested that Shirvan herbal ointment can be an alternative drug in the treatment of human CL.