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The effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on leishmaniasis : Randomized and double-blind clinical trial

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History
# Registration date Revision Id
4 2022-11-08, 1401/08/17 279109
3 2022-10-20, 1401/07/28 243376
2 2022-10-19, 1401/07/27 243302
1 2022-04-12, 1401/01/23 222459
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  • General information

    88
    300
    empty
    More patients enter to the study
    empty
    افزایش تعداد بیمار جهت ورود به مطالعه

  • Intervention groups

    #1
    Intervention group: The intervention group is included 44 patients with cutaneous leishmaniasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
    Intervention group: The intervention group is included 150 patients with cutaneous leishmaniasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
    گروه مداخله: گروه مداخله شامل 44 بیمار مبتلا با لیشمانیوز جلدی است. کرم موضعی حاوی 0.5 گرم گیاه مامیران و 0.5 گرم بذرالبنج به همراه 2 گرم بره موم طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند.
    گروه مداخله: گروه مداخله شامل 150بیمار مبتلا با لیشمانیوز جلدی است. کرم موضعی حاوی 0.5 گرم گیاه مامیران و 0.5 گرم بذرالبنج به همراه 2 گرم بره موم طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند.
    #2
    Control group: Intervention group: The intervention group is included 44 patients with cutaneous leishmaniasis . Topical Amphotericin B used .he duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin B is prepared in a tube identical to the intervention group , Delivered to patients .
    Control group: Intervention group: The intervention group is included 150 patients with cutaneous leishmaniasis . Topical Amphotericin B used .he duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin B is prepared in a tube identical to the intervention group , Delivered to patients .
    گروه کنترل: گروه مداخله شامل 44 بیمار مبتلا با لیشمانیوز جلدی است. درمان موضعی با آمفوتیسین بی استفاده میشود . که طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. آمفوتریپسین بی در تیوب همسان با گروه مداخله تهیه و در اختیار بیماران قرار میگیرد
    گروه کنترل: گروه مداخله شامل 150 بیمار مبتلا با لیشمانیوز جلدی است. درمان موضعی با آمفوتیسین بی استفاده میشود . که طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. آمفوتریپسین بی در تیوب همسان با گروه مداخله تهیه و در اختیار بیماران قرار میگیرد

  • Recruitment centers

    #1
    Name of recruitment center - English: Esfarayen faculty of medical science ,health assistant
    Name of recruitment center - Persian: دانشکده علوم پزشکی و خدمات بهداشتی درمانی اسفراین ، معاونت بهداشتی
    Full name of responsible person - English: Alireza Ekrami
    Full name of responsible person - Persian: علیرضا اکرمی
    Street address - English: Taleghani street , Esfarayen faculty of medical science ,health assistant
    Street address - Persian: خیابان طالقانی ، دانشکده علوم پزشکی و خدمات بهداشتی درمانی اسفراین ، معاونت بهداشتی
    City - English: Esfarayen
    City - Persian: اسفراین
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: ۹۶۶١۸-۷۶۹۸١
    Phone: +98 83 88517
    Fax:
    Email: Info@esfrums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Abu Zaid Abad Health Center
    Name of recruitment center - Persian: مرکز بهداشتی ابوزید اباد
    Full name of responsible person - English: Nwsha behzadseresht
    Full name of responsible person - Persian: نیوشا بهزاد سرشت
    Street address - English: Beheshti Blvd, Abu Zaid Abad Health Center
    Street address - Persian: بلوار بهشتی ، مرکز بهداشتی ابوزید اباد
    City - English: Abu Zaid Abad
    City - Persian: ابوزید آباد
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8748139851
    Phone: +98 31 5485 4411
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
    #3
    Name of recruitment center - English: comprehensive health service center pamili
    Name of recruitment center - Persian: مرکز خدمات جامع سلامت پامیلی
    Full name of responsible person - English: Leila Mobini Arani
    Full name of responsible person - Persian: لیلا مبینی آرانی
    Street address - English: Shahid Mehrdad Rabbani St, comprehensive health service center pamili
    Street address - Persian: خیابان شهید مهرداد ربانی ، مرکز خدمات جامع سلامت پامیلی
    City - English: Aran
    City - Persian: آران
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8741637674
    Phone: +98 31 5474 6230
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
    #4
    Name of recruitment center - English: comprehensive health service Dr. Namaki
    Name of recruitment center - Persian: مرکز خدمات جامع سلامت دکتر نمکی
    Full name of responsible person - English: gila Nikbakht Bidgoli
    Full name of responsible person - Persian: ژیلا نیکبخت بیدگلی
    Street address - English: Mohammad Hilal St, comprehensive health service Dr. Namakice center pamili
    Street address - Persian: خیابان محمد هلال ، مرکز خدمات جامع سلامت دکتر نمکی
    City - English: Bidgol
    City - Persian: بیدگل
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5472 2025
    Fax:
    Email: research@kaums.ac.ir
    Web page address:

Protocol summary

Study aim
The effect of topical cream containing Chelidonium majus and and Hyoscyamus niger with propolis on healing cutaneous Leishmaniasis
Design
The clinical trial is designed as an intervention with a control group, double-blind, randomized, in phase 3 on 88 patients.
Settings and conduct
A double-blind study is performed on 88 patients with diabetic ulcers in Shahid Beheshti of Kashan and Al Zahra of Isfahan hospitals. The doctor and the patient do not know the type of treatment. The patients receive topical cream containing Chelidonium majus and Hyoscyamus niger with Propolis during three weeks. The duration of each cream will be 7days and the treatment will be done once a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Entry requirements include men and women at least 12 years of age Positive leishmania smear Exclusion criteria: Pregnancy, breast feeding, Number of lesion over ten
Intervention groups
Intervention group: The intervention group is included 44 patients with cutaneous leishmaniasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Control group: Intervention group: The intervention group is included 44 patients with cutaneous leishmaniasis . Topical Amphotericin B used .he duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin B is prepared in a tube identical to the intervention group , Delivered to patients .
Main outcome variables
Measuring the size of lesion induration diameter with caliper

General information

Reason for update
More patients enter to the study
Acronym
IRCT registration information
IRCT registration number: IRCT20200516047462N5
Registration date: 2022-04-12, 1401/01/23
Registration timing: prospective

Last update: 2022-10-19, 1401/07/27
Update count: 3
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
morteza kosari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5434 6622
Email address
yeganehbadi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on leishmaniasis : Randomized and double-blind clinical trial
Public title
The effect of Chelidonium majus and hyoscyamus niger with propolis on cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Entry requirements include men and women at least 12 years of age Positive leishmania smear
Exclusion criteria:
Pregnancy, breast feeding, Number of lesion over ten
Age
From 12 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into two groups by terminated block randomization method with blocks of 4 and 6, prescription drugs (intervention and placebo) are determined based on this method and a special number is assigned to them Physician and patient are unaware of drug or placebo receiving and there are codes that were registered on cream and only the epidemiologist informs as a plan executor.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention and placebo cream is completely identical in terms of the shape and size of the container, and the cream themselves do not differ in terms of color, and are completely indistinguishable. The important point is that the patient is told that the topical cream used for the patient may be medication or controlled drug . Clinicians and patients will be blinded
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Shahid Beheshti Hospital, University of Medical Sciences, Kashan, Iran.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.199

Health conditions studied

1

Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis

Primary outcomes

1

Description
Complete healing
Timepoint
At the beginning of the study, 2 and 4 days after treatment and 7 days after treatment, 14 days after treatment, 21 days after treatment
Method of measurement
measuring the size of lesion induration diameter with caliper

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group is included 150 patients with cutaneous leishmaniasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Category
Treatment - Drugs

2

Description
Control group: Intervention group: The intervention group is included 150 patients with cutaneous leishmaniasis . Topical Amphotericin B used .he duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin B is prepared in a tube identical to the intervention group , Delivered to patients .
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Morteza kosari
Street address
Ghotb Ravandi Blvd, Shahid Beheshti Hospital of Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir

2

Recruitment center
Name of recruitment center
Esfarayen faculty of medical science ,health assistant
Full name of responsible person
Alireza Ekrami
Street address
Taleghani street , Esfarayen faculty of medical science ,health assistant
City
Esfarayen
Province
North Khorasan
Postal code
۹۶۶١۸-۷۶۹۸١
Phone
+98 83 88517
Email
Info@esfrums.ac.ir

3

Recruitment center
Name of recruitment center
Abu Zaid Abad Health Center
Full name of responsible person
Nwsha behzadseresht
Street address
Beheshti Blvd, Abu Zaid Abad Health Center
City
Abu Zaid Abad
Province
Isfehan
Postal code
8748139851
Phone
+98 31 5485 4411
Email
research@kaums.ac.ir

4

Recruitment center
Name of recruitment center
comprehensive health service center pamili
Full name of responsible person
Leila Mobini Arani
Street address
Shahid Mehrdad Rabbani St, comprehensive health service center pamili
City
Aran
Province
Isfehan
Postal code
8741637674
Phone
+98 31 5474 6230
Email
research@kaums.ac.ir

5

Recruitment center
Name of recruitment center
comprehensive health service Dr. Namaki
Full name of responsible person
gila Nikbakht Bidgoli
Street address
Mohammad Hilal St, comprehensive health service Dr. Namakice center pamili
City
Bidgol
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5472 2025
Email
research@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimorteza12@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimortza12@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan
City
Isfehan
Province
Isfehan
Postal code
8715988141
Phone
+98 87 1598 8141
Email
kosarimorteza12@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about participants such as age, gender, level of education and employment will be reported. The treatment protocol and the duration of treatment process will be reported. Therapeutic results of the product and possible side effects will be reported.
When the data will become available and for how long
The start of the access period will be 6 months after patent presentation or 12 months after article publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutes.
Under which criteria data/document could be used
The data printed in the article is accessible.
From where data/document is obtainable
Moderator: Morteza Kosari , Email address: kosarimorteza12@gmail.com
What processes are involved for a request to access data/document
We will try to respond to researchers as soon as possible.
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