Evaluation of the effect of herbal product containing indigo (Indigofera argentea), pistachio gum (pistacia atlantica) and chia seed (Salvia hispanica) in patients with rural cutaneous leishmaniasis based on folk medicine of Sistan and Baluchestan province
Determining the effect of herbal product containing indigo (Indigofera argenea), pistachio gum (pistacia atlantica) and chia seed (Salvia hispanica) based on folk medicine of Sistan and Baluchestan province in patients with rural cutaneous leishmaniasis referred to health centers in Chabahar in 2021-2022
Design
The clinical trial has a control group with parallel double-blind groups. The intervention and control are divided into two groups of 30. Randomization is done by allocating patients to two groups using the randomized permutation block method and in quadruple blocks.
Settings and conduct
Candidates are selected from those who refer to Chabahar health centers who have leishmaniasis ulcers and a doctor's diagnosis with the approval of the laboratory and the inclusion criteria.
The dimensions of the wound are determined with a caliper and a camera equipped with the software. For each participant of the control and intervention group, physician, caregiver, nurses and analyst of the control and placebo group, drug packaging and placebo are not recognizable.
Participants/Inclusion and exclusion criteria
Age range 18 - 70 years old; existence of skin ulcers; positive smear and PCR test result; topically injected glucantime treatment; absence of physical diseases such as: liver disease, cardiovascular problems and kidney problems; no pregnancy and lactation; no atypical wounds.
Intervention groups
Both groups receive the main drug. The intervention group received herbal product topically and the control group received placebo twice a day for one month. The wound dimensions were measured before the intervention, on days: 7, 14, 21 and one month after.
Main outcome variables
Evaluation of the effect of herbal product on wound healing process by measuring wound dimensions and area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210905052377N1
Registration date:2021-12-15, 1400/09/24
Registration timing:prospective
Last update:2021-12-15, 1400/09/24
Update count:0
Registration date
2021-12-15, 1400/09/24
Registrant information
Name
Saeidali Bozorgzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3531 5212
Email address
s.bozorgzade@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of herbal product containing indigo (Indigofera argentea), pistachio gum (pistacia atlantica) and chia seed (Salvia hispanica) in patients with rural cutaneous leishmaniasis based on folk medicine of Sistan and Baluchestan province
Public title
Evaluation of the effect of traditional indigo, pistachio gum and chia seeds on leishmaniasis skin wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Wet skin lesions
Laboratory diagnosis of positive smear with Giemsa staining
Positive PCR test
Treated with topical - injectable glucantime
Signing the informed consent of the person or his / her guardian
Exclusion criteria:
Lack of physical diseases such as liver disease, cardiovascular problems and kidney problems
No pregnancy and lactation
No history of leishmaniasis in the past
Lack of recurrences and failure of classical treatment
No atypical wounds
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by assigning patients to two groups using the permutation random block method in 4 blocks.The random permutation block table for the two groups, based on which patients are assigned to the two groups, is prepared using the R software as follows. (A) is the control group and (B) is the intervention group.
B A
A A
A B
A A
B B
A A
B B
B B
B A
A B
B A
A A
B B
A B
B A
B B
A A
B B
A B
A B
A A
B A
A B
B A
A A
B B
B B
A B
A A
B A
Blinding (investigator's opinion)
Double blinded
Blinding description
Eligible and volunteer patients are randomly divided into two groups of 30 patients. Patients do not know which drug or placebo each member of the group is receiving. The treating physician, filing staff who measure and monitor the size of the wound, and nursing staff who inject glucantime injections topically and dress the wounds of both groups with medication and placebo are also unable to diagnose the drug and placebo. For standardization and blinding, herbal powder and placebo powder, which is the same color as the standard food coloring of the plant powder, are placed in identical one-gram capsules, and the cans for the capsules are marked similarly and marked with the abbreviations A and B. When consuming the powder, it is taken out of the capsule and with distilled water, it becomes a paste with a firm consistency and the patient's wound is bandaged. At the end, statistical information is given anonymously to the statistician to analyze the information
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-11-08, 1400/08/17
Ethics committee reference number
IR.KMU.REC.1400.488
Health conditions studied
1
Description of health condition studied
Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Rural leishmaniasis skin lesion
Timepoint
Before the intervention and the days (7, 14, 21, 28) and one month after
Method of measurement
With a caliper, two cross diameters of the wound are measured in centimeters. The wound area in terms of square centimeters is calculated by a camera with software.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Simultaneously with the use of the patient's main drug, the compounds of this study, including indigo, coriander gum and chia seeds, after preparation from reputable perfumers in Chabahar, are studied by botanists of the Faculty of Traditional Medicine and the Kerman School of Pharmacy to identify the genus and species. Plant registration in the herbarium of Kerman University of Medical Sciences has been performed by obtaining the herbarium number. Taking UV rays for disinfection is subject to microbial control tests. And after standardization, it is packaged. Due to the fact that the amount of oral consumption of Nile 2 derms is equal to 6.2 grams, coriander gum 2 mesqal is equal to 9 grams and Lesan al-Abal 3 derms is equal to 9.3 grams in traditional medicine texts and the consumption of chia seeds is up to 25 grams. Since the use of some drugs in traditional medicine as powder extracts, first the dough is placed in molds of the desired dimensions and then dried and stored, and when needed and used, the dough is put back on the stand with some water. In the common method of Balochistan region, some of the mixed powder with some water is made into a paste with medium consistency and is placed on the wound and then it is bandaged with a clean cloth. In this study, for standardization and blinding, it was planned that the powder in the amount of 1000 mg be placed in large capsules of 1 g and when used, it is combined with 0.6 cc of distilled water and made into a paste with medium consistency. The amount used for wound dressing is to create a layer the size of a wound with a thickness of three millimeters of the product. Therefore, first the content of each capsule is converted into a paste and then based on the dimensions of the lesion, all or some of it is used. This product is used twice a day for a month.
Category
Treatment - Drugs
2
Description
Control group: This group also receives the main drug similar to the intervention group. Placebo, which is prepared from food powder and matched with the ineffective standard food color of the product, is placed in capsules of the same color and weight. It is exactly the same as the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chabahar Health Center
Full name of responsible person
Dr. Abdolrasool khedmati
Street address
Comprehensive Health Center No. 4, next to the Emergency Center, Imam Khomeini St.
City
Chabahar
Province
Sistan-va-Balouchestan
Postal code
9971855531
Phone
+98 54 3531 2413
Email
gmail.com@0096
Web page address
https://www.irshums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhty
Street address
Ebn-e-Sina St.,Jahad Blvd., Kernan,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3855 3226
Fax
Email
VCR@KMU.AC.IR
Web page address
http://www.vresearch.kmu.ac.ir
Grant name
400000218
Grant code / Reference number
00/10/60/218
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Saeedali Bozorgzade
Position
PhD student in Iranian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of persian Medicine, Kerman University of Medical Sciences, Haft Bagh Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
31326161 34 0098
Fax
Email
S.bozorgzade@kmu.ac.ir
Web page address
http://www.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hossein Karegar Barzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Kerman University of Medical Sciences, Haft Bagh Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
31326161 34 0098
Fax
Email
karegar.h.b@gmail.com
Web page address
https://kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeidali bozorgzade
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Kerman University of Medical Sciences, Haft Bagh Blvd
City
kerman
Province
Kerman
Postal code
7616913555
Phone
31336161 34 0098
Fax
Email
S.bozorgzade@kmu.ac.ir
Web page address
http://www.kmu.ac.ir
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
Summary of all personal information that is examined and analyzed for the main, sub-purposes in the relevant tables that are necessary for the publication of articles in foreign and domestic scientific journals are provided. The application form is submitted through their related scientific institutions
When the data will become available and for how long
Six months after the article was published
To whom data/document is available
The data will be accessible to researchers upon request through the relevant science center, and industrialists upon request through the relevant authorities.
Under which criteria data/document could be used
For use in scientific research with reference
From where data/document is obtainable
Saeidali Bozorgzade
S.bozorgzade@kmu.ac.ir
What processes are involved for a request to access data/document
After receiving the request and coordination with the supervisor and research assistant of Kerman University of Medical Sciences, the materials will be sent.