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Trial results
No
Yes
1
empty
2026-07-02, 1405/04/11
2026-07-02 06:45:07
empty
2024-08-26, 1403/06/05
2024-08-26 00:00:00
empty
http://10.4103/abr.abr_243_23
http://10.4103/abr.abr_243_23
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
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
P-value
کنترل (n=30)
تست (n=30)
0.07
33.16±12.80
26.9±13.3
سن (سال)
0.265
2.1±1.1
1.8±1.1
میانگین تعداد ضایعات
0.00
43.9±14.4
30.5±7.4
میانگین طول مدت درمان (روز)
0.66
0.8±0.84
0.9±0.92
میانگین موقعیت ضایعه (اندامهای فوقانی)
P-value
کنترل (n=30)
تست (n=30)
0.07
33.16±12.80
26.9±13.3
سن (سال)
0.265
2.1±1.1
1.8±1.1
میانگین تعداد ضایعات
0.00
43.9±14.4
30.5±7.4
میانگین طول مدت درمان (روز)
0.66
0.8±0.84
0.9±0.92
میانگین موقعیت ضایعه (اندامهای فوقانی)
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
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
P-value
کنترل (n=30)
تست (n=30)
هفته
0.93
51.5±32.5
50.8±31.2
فبل از درمان
0.5
45.9±31.1
40.9±26.4
هفته اول
0.139
40.1±29.2
30.1±21.4
هفته دوم
0.04
31.3±25.8
19.3±18.0
هفته سوم
0.003
23.6±22.4
9.2±11.7
هفته چهارم
0.001
17.6±19.6
3.8±6.9
هفته پنجم
0.00
12.6±15.7
92±2.3.
هفته ششم
0.00
11.5±16.1
00.±.00
هفته هفتم
0.00
11.1±16.2
00.±.00
هفته هشتم
P-value
کنترل (n=30)
تست (n=30)
هفته
0.93
51.5±32.5
50.8±31.2
فبل از درمان
0.5
45.9±31.1
40.9±26.4
هفته اول
0.139
40.1±29.2
30.1±21.4
هفته دوم
0.04
31.3±25.8
19.3±18.0
هفته سوم
0.003
23.6±22.4
9.2±11.7
هفته چهارم
0.001
17.6±19.6
3.8±6.9
هفته پنجم
0.00
12.6±15.7
92±2.3.
هفته ششم
0.00
11.5±16.1
00.±.00
هفته هفتم
0.00
11.1±16.2
00.±.00
هفته هشتم
empty
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.
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.
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مقدمه: عفونت لیشمانیوز جلدی (CL) توسط انگل لیشمانیا ماژور (L. major) ایجاد می شود و سالانه 1.5 تا 2 میلیون نفر در سراسر جهان را مبتلا می کند. اگرچه تحقیقات در مورد واکسن ها و داروهای ضد انگلی تا حدودی موفقیت آمیز بوده است، اما اثرات نامطلوب آنها شامل سمیت بالا، بازسازی طولانی مدت و ایجاد زخم است. این امر اهمیت تحقیقات برای جایگزینی محصولات طبیعی با خواص ضد باکتریایی و آنتی اکسیدانی مانند عصاره ها و روغن های گیاهی را برجسته کرده است. از آنجایی که اثر ضد لیشمانیوز هر یک از ترکیبات پماد گیاهی شیروان (آلوئه ورا، برازمبل، سیاهدانه، بره موم) روغن اسطوخودوس و زیتون) به طور جداگانه مورد مطالعه و تایید قرار گرفته است، به نظر می رسد که ترکیب این اجزا می تواند اثر ضد لیشمانیایی فزاینده ای برای درمان CL داشته باشد.
هدف: لذا این مطالعه به بررسی تأثیر درمانی پماد گیاهی شیروان بر بیماران ایرانی مبتلا به سالک در مقایسه با گلوکانتیم (مگلومین) پرداخت.
روش: 60 بیمار مبتلا به لیشمانیوز به دو گروه کنترل و آزمایش تقسیم شدند. گروه کنترل و آزمون به ترتیب گلوکانتیم داخل ضایعه و کرم گیاهی شیروان (روزی دو بار) دریافت کردند.
یافتهها: میانگین اندازه ضایعه قبل از درمان 5/32 ± 5/51 و بعد از درمان 28/16 ± 11/11 در گروه شاهد و 2/31 ± 8/50 قبل و 0/0 ± 0/0 بعد از درمان در گروه آزمون بود. همچنین میانگین دوره درمان در گروه کنترل و آزمون به ترتیب 4/14 ± 9/43 روز و 4/7 ± 5/30 روز بود. بعد از درمان بین دو گروه تفاوت معنی داری در اندازه ضایعه وجود داشت.
نتیجهگیری: داده ها حاکی از آن است که پماد گیاهی شیروان می تواند یک داروی جایگزین در درمان CL انسانی باشد.
مقدمه: عفونت لیشمانیوز جلدی (CL) توسط انگل لیشمانیا ماژور (L. major) ایجاد می شود و سالانه 1.5 تا 2 میلیون نفر در سراسر جهان را مبتلا می کند. اگرچه تحقیقات در مورد واکسن ها و داروهای ضد انگلی تا حدودی موفقیت آمیز بوده است، اما اثرات نامطلوب آنها شامل سمیت بالا، بازسازی طولانی مدت و ایجاد زخم است. این امر اهمیت تحقیقات برای جایگزینی محصولات طبیعی با خواص ضد باکتریایی و آنتی اکسیدانی مانند عصاره ها و روغن های گیاهی را برجسته کرده است. از آنجایی که اثر ضد لیشمانیوز هر یک از ترکیبات پماد گیاهی شیروان (آلوئه ورا، برازمبل، سیاهدانه، بره موم) روغن اسطوخودوس و زیتون) به طور جداگانه مورد مطالعه و تایید قرار گرفته است، به نظر می رسد که ترکیب این اجزا می تواند اثر ضد لیشمانیایی فزاینده ای برای درمان CL داشته باشد. هدف: لذا این مطالعه به بررسی تأثیر درمانی پماد گیاهی شیروان بر بیماران ایرانی مبتلا به سالک در مقایسه با گلوکانتیم (مگلومین) پرداخت. روش: 60 بیمار مبتلا به لیشمانیوز به دو گروه کنترل و آزمایش تقسیم شدند. گروه کنترل و آزمون به ترتیب گلوکانتیم داخل ضایعه و کرم گیاهی شیروان (روزی دو بار) دریافت کردند. یافتهها: میانگین اندازه ضایعه قبل از درمان 5/32 ± 5/51 و بعد از درمان 28/16 ± 11/11 در گروه شاهد و 2/31 ± 8/50 قبل و 0/0 ± 0/0 بعد از درمان در گروه آزمون بود. همچنین میانگین دوره درمان در گروه کنترل و آزمون به ترتیب 4/14 ± 9/43 روز و 4/7 ± 5/30 روز بود. بعد از درمان بین دو گروه تفاوت معنی داری در اندازه ضایعه وجود داشت. نتیجهگیری: داده ها حاکی از آن است که پماد گیاهی شیروان می تواند یک داروی جایگزین در درمان CL انسانی باشد.
Protocol summary
Study aim
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:2026-07-02, 1405/04/11
Update count:1
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.
Director of the Research Center for Skin Diseases and Salk
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sedighe And Tahereh Clinic. Khoram Street, Jomhoori Square ,
City
Isfahan
Province
Isfehan
Postal code
81876- 98191
Phone
+98 31 3339 0100
Email
emrc@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Aghaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Sedighe And Tahereh Clinic, Khoram Street, Jomhori Square
City
Isfahan
Province
Isfehan
Postal code
81876- 98191
Phone
+98 31 3339 0100
Email
maryam.aghaei2008@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Trial results
Please tick if results have been published
Yes
Summary result posting date
2026-07-02, 1405/04/11
Table of baseline comparison
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
Participant flow diagram
Table of variable outcomes' results
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
Table of adverse events
First publication date
2024-08-26, 1403/06/05
Abstract of published paper
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.