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IRCT20230621058552N1 IRCT 2023-06-28 Esfahan University of Medical Sciences Comparison the effect of Shirvan herbal ointment and glucantim drug on the cutaneous leshmaniasis wounds. Comparison the therapeutic effect of Shirvan herbal ointment with glucantim drug on the cutaneous leshmaniasis wounds. 2023-08-23 anticipated 10 Complete https://irct.ir/trial/70919 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Leishmaniasis. 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.. http://10.4103/abr.abr_243_23 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Maryam Aghaei
Sedigheh Tahereh Hospital. Khoram Street. Jomhori Square
Isfahan Iran (Islamic Republic of) 81876- ‎98191 +98 31 3339 0100 maryam.aghaei2008@gmail.com Esfahan University of Medical Sciences scientific Dr. Zabih Allah Shahmoradi
Sedighe And Tahereh Clinic. Khoram Street, Jomhoori Square ,
Isfahan Iran (Islamic Republic of) 81876- ‎98191 +98 31 3339 0100 emrc@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Confirmed cases of urban leishmaniasis. Informed consent signed The diameter of the lesion < 2 cm. Lesions only in hands and feet. no limit no limit Both 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 Z68.53 Body mass index (BMI) pediatric, 85th percentile to less than 95th percentile for age Treatment - Drugs 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. 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. Esfahan University of Medical Sciences Approved 2023-03-14 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Street . Azadi Square. Isfahan Isfehan Iran (Islamic Republic of)