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Evaluation of the effect of two herbal products (blend of vinegar, Plantago ovata and cotton) in comparison with placebo in patients with standard treatment of leishmaniasis in rural type center.

Protocol summary

Study aim
Evaluation of the effect of two herbal products (blend of vinegar, Plantago ovata and cotton) in comparison with placebo in patients with standard treatment of leishmaniasis in rural type center.
Design
A phase 3 clinical trial with a control group, with parallel, double-blind and randomized groups. Simple random by envelope method. Each group has 44 people.Total 132 people.
Settings and conduct
After approval of herbs and toxicological and microbial tests, medicines are given to patients in similar forms. Patients and health care providers are not aware of the drug content. Full patient and wound characteristics are recorded. Before the start of treatment, the end of the first, second, third, fourth and eighth weeks of wound healing and clinical information (including wound size, induration size, and epithelialization rate) will be measured and recorded. Patients will be taken in Yazd and Ardakan centers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Test positive, age between 6 and 60 years, wound diameter less than 3 cm, 4 lesions and less. Exclusion criteria: Complicated Types, 5 Lesions and Over, Wound Diameter Over 3cm, Lactating and Pregnant Women, Facial Wounds, Sensitivity to Glucantime, Onset of More Than 3 Months, Use of Other Anti-leishmaniosis Medications in the Past Month.
Intervention groups
Patients were randomly divided into three groups of 44 patients. Patients are randomly assigned to one of the following study groups: 1- The group receiving the composition of vinegar and plantago ovata. 2- Receiving group of cotton plant product. 3. Control group. All patients will receive standard treatment for cutaneous leishmaniasis based on the latest national guidelines.
Main outcome variables
The surface of the wound

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191221045845N1
Registration date: 2020-01-29, 1398/11/09
Registration timing: registered_while_recruiting

Last update: 2020-01-29, 1398/11/09
Update count: 0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
Sayed Mehrdad Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3223 8916
Email address
sm.mousavi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of two herbal products (blend of vinegar, Plantago ovata and cotton) in comparison with placebo in patients with standard treatment of leishmaniasis in rural type center.
Public title
The effect of medicinal plants on the leishmaniosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Proof of cutaneous leishmaniasis through smear The patients should not be less than 6 years old and not more than 60 years old The lesion size should be less than 3 cm The duration of the illness is less than 12 weeks No lesion on the face Not having any other anti-leishmaniasis medication in the past 4 weeks Don't be pregnant or breastfeeding Do not have severe skin disease such as eczema, psoriasis or chronic dermatitis of unknown origin Has no serious, chronic or malignant disease and is not under chemotherapy treatment Has 4 or less lesions in the body No travel history 6 months ago
Exclusion criteria:
The type of cutaneous leishmaniasis may be complicated, with complications such as a patient with mucosal leishmaniasis Having 5 lesions and more Lesions greater than 3 cm Subcutaneous nodules Regional adenopathy larger than 1 cm People with immunodeficiency Children under 6 years Women in Lactation and Pregnancy sporotrichoid leishmaniasis or satellite lesions Patients with ulcers on the face Patients with a history of drug allergy to antimony compounds Patients who have had more than three months since their first skin lesions appeared Patients who have used any method of treatment for cutaneous leishmaniasis during the past month Patients with a history of travel to other areas of leishmaniasis in the past 6 months as well as those of urban leishmaniasis
Age
From 6 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 132
More than 1 sample in each individual
Number of samples in each individual: 3
wound
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization envelops shuffling
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the participants and the clinical caregiver, the drugs are labeled with codes 1, 2, and 3 (placebo). The patient and the clinical caregiver and principal investigator are unaware of the type of drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of yazd University of Medical Sciences
Street address
school of Iranian Medicine,Imam Khomeini street, ardekan, yazd
City
yazd
Province
Yazd
Postal code
8951737915
Approval date
2019-10-08, 1398/07/16
Ethics committee reference number
IR.SSU.REC.1398.136

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
Leishmaniasis lesion area
Timepoint
Before treatment and then every week until healing or the eighth week
Method of measurement
Mathematical calculations with mm-square scale

Secondary outcomes

1

Description
Wound healing time
Timepoint
End of treatment
Method of measurement
Time between start and end of treatment in days

Intervention groups

1

Description
Intervention group: Standard treatment plus cream (topical medicinal product) containing extract of cotton plant is administered twice daily for 8 weeks.
Category
Treatment - Drugs

2

Description
Intervention group: Standard treatment plus cream (topical medicinal product) containing the combination of plantago ovata and vinegar is given twice daily for 8 weeks.
Category
Treatment - Drugs

3

Description
Control group: Standard treatment plus placebo is given twice daily for 8 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd University of Medical Sciences
Full name of responsible person
Sayed Mehrdad Mousavi
Street address
imam khomeini
City
Ardekan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3223 8917
Fax
+98 31 3223 8915
Email
sm.mousavi@stu.ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
majid emtiazy
Street address
school of iranian medicine, Imam Khomeini Ave,Ardekan.
City
yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3223 8917
Fax
+98 35 3223 8915
Email
dr.emtiazy@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
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
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
school of iranian medicine, Imam Khomeini Ave,Ardekan.
City
Ardekan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3223 8915
Fax
+98 35 3223 8915
Email
dr.emtiazy@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Ebrahimzade
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Yazd University of Medical Sciences
City
yazd
Province
Yazd
Postal code
8916978477
Phone
03537240171-5
Email
mohammad110eb@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sayed Mehrdad Mousavi
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Khomeini Ave, school of Iranian Medicine
City
Ardekan
Province
Yazd
Postal code
8951737915
Phone
03532238916-7
Email
dr_smmd@yahoo.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Monitoring information during the study
When the data will become available and for how long
Upon first request or about a week
To whom data/document is available
Applicant's subordinate authorities
Under which criteria data/document could be used
Proof, Understanding and Exploitation
From where data/document is obtainable
Person responsible for updating information
What processes are involved for a request to access data/document
Request the person responsible for the public accountability of the trial
Comments
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