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Comparing the effect of leech therapy on the severity and extent of psoriasis lesions compared to conventional medical treatments in psoriasis patients

Protocol summary

Study aim
Determining the effectiveness of leech therapy on the recovery period of psoriasis in patients referred to Shahid Faqihi Hospital and Amirul Mominin Burn Hospital in Shiraz in 1402-1403
Design
The researcher will refer to the dermatology department of the mentioned hospitals and 60 patients will be selected using the available sampling method based on the entry and exit criteria. And then they will be randomly assigned to intervention and control groups in parallel with the help of Random Generator Software. Demographic information checklist and PASI evaluation checklist will be filled for both groups. Intervention group patients will be taught about leech therapy and how to do the work. The study will be double-blind
Settings and conduct
The study site is Shahid Faqihi Hospital and Amirul Mominin Hospital of Shiraz University of Medical Sciences The statistical consultant and evaluator knew which patients belong to the control group and which belong to the intervention group in all phases of the study
Participants/Inclusion and exclusion criteria
inclusion criteria: Age 60-20, not suffering from other skin disorders, having symptoms of psoriasis, not allergic to leeches, willingness to participate in the study exclusion criteria: Pregnancy and breastfeeding, not wanting to continue studying, not following the treatment process and not attending meetings regularly Taking vitamin K, E, C, herbal supplements such as garlic, ginger, ginkgo, ginseng compounds, aspirin, dipyridamole, clopidogrel, heparin, warfarin and non-steroidal anti-inflammatory drugs
Intervention groups
Intervention group: (leech therapy): The intervention will be carried out for 5 weeks, with a time interval of 7 days, by placing 10 leeches in the psoriasis area, in addition to routine care. Control group: routine care only
Main outcome variables
The intensity of the psoriasis area, the size of the psoriasis area

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230821059210N1
Registration date: 2023-09-24, 1402/07/02
Registration timing: registered_while_recruiting

Last update: 2023-09-24, 1402/07/02
Update count: 0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Ehsan Khavare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 0851
Email address
khavareehsan58@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of leech therapy on the severity and extent of psoriasis lesions compared to conventional medical treatments in psoriasis patients
Public title
The effectiveness of leech therapy on the healing period of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 20-60, Absence of other skin disorders Having symptoms of psoriasis Insensitivity to leech
Exclusion criteria:
Failure to attend meetings regularly Failure to follow the treatment process Pregnancy and breastfeeding Not using vitamins K, E, C, herbal supplements such as garlic, ginger, ginkgo, ginseng compounds, aspirin, dipyridamole, clopidogrel, heparin, warfarin and non-steroidal anti-inflammatory drugs.
Age
From 20 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After going to the departments of both hospitals and getting the list of patients from them, the patients will be contacted and interested people will be registered. Then, from the obtained list, 60 people will be randomly selected into the random number table, and with the help of the Random Number Generator software, out of 60 people (numbers 1-60), 30 people will be randomly assigned to the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
1- The statistical expert will be unaware of the intervention and control group. He will not be told whether the data is from the intervention or control group. Rather, only the groups will be marked with numbers 1 and 2 or with A-B, so only the researcher knows and he can interpret the results. 2- The nurses providing routine care and the person collecting data at the end of the study will also be blinded. That is, they will not know which patient was in the intervention group and which patient was in the control group. Patients are given codes and only the researcher knows these codes
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
motahari street
City
jahrom
Province
Fars
Postal code
7414846199
Approval date
2023-07-29, 1402/05/07
Ethics committee reference number
034.IR.JUMS.REC.1402

Health conditions studied

1

Description of health condition studied
psoriasis
ICD-10 code
psoriasis
ICD-10 code description
L40.0

Primary outcomes

1

Description
Severity and extent of psoriasis
Timepoint
Before and after the intervention in both intervention and control groups
Method of measurement
Before and after the intervention by the index of the extent and severity of psoriasis by a specific checklist Psoriasis Area Severity Index (PASI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The amount of PASI will be checked before the start of the study. Then, for 5 weeks, with a time interval of 7 days, it will be done by placing 10 leeches in the affected area. Before using the leech, the leech will be kept in non-chlorinated water for 24 hours, and before sticking the leech, the target area will be washed with water and odorless soap. Then, wearing gloves, the leech will be removed. In order to prevent the irritation and irritation of the leech. At first, 10 leeches are placed in the infected areas and the leech treated area is observed and examined for 2 minutes (to check that the leech sticks and sucks blood). If the leech is able to stick and no blood sucking, with a needle, a small incision will be made in the area and the leech will be placed on that area. Then a wet gauze or a transparent plastic cup will be placed on it to provide moisture to the leech's body and prevent the leech from moving. During the leech treatment, the patient will be checked for bleeding, sensitivity, removal of the leech, movement and vital signs of the patient. After sucking the blood by the leech, the leech will either be removed by itself or it can be removed by pouring a few drops of alcohol or betadine. and in order to prevent the possible transmission of infection by leech, it should be destroyed by pouring alcohol. After each leech treatment session, the patient will be checked for the amount of bleeding and stabilization of vital signs, and if there is no problem, he will be discharged. Before the start of the study and after the end of leprosy therapy, the PASI level of the patients in both groups will be checked. It is worth noting that the patients will receive common psoriasis treatments during the study.
Category
Treatment - Other

2

Description
Control group: They receive common and standard psoriasis treatments, and before and after the intervention in the intervention group, a checklist to determine the severity and extent of psoriasis is completed for them.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
SHahid fagihi shiraz
Full name of responsible person
Amirreza Dehghanian
Street address
Shiraz - Karim Khan Zand Boulevard - in front of Shahid Faqihi Street (Rosutgar) - next to the medical school
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۶۱۱۴
Phone
+98 71 3212 5400
Email
ADehghan@Sums.ac.ir
Web page address
https://faghihi.sums.ac.ir/page-FgPresidency/fa/34/form/pId1445

2

Recruitment center
Name of recruitment center
Amir al-Momenin Hospital, Shiraz
Full name of responsible person
Mohammad Mehdi Aslani
Street address
Shiraz, km 2 of Sadra Road, Amirul Mominin Burn Accident and Rehabilitation Hospital
City
Shiraz
Province
Fars
Postal code
۷۱۹۸۷۵۳۸۵۴
Phone
+98 71 3614 6100
Email
amiralmomeninbh@sums.ac.ir
Web page address
https://amiralmomeninbh.sums.ac.ir/page-amiralmomeninhp/fa/32/form/pId1363

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavoss solhjo
Street address
Jahrom - Ostad Motahari St. - after the Nursing Faculty - Jahrom University of Medical Sciences - campus site
City
Jahrom
Province
Fars
Postal code
۷۴۱۴۸۴۶۱۹۹
Phone
+98 71 5434 0409
Email
Pazhuheshi@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen fasele
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom Motahari Street. University campus site. nursing school
City
jahrom
Province
Fars
Postal code
7414846199
Phone
0098 71 5433001
Email
m.fasele@jums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen fasele
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom Motahari Street. University campus site. nursing school
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
0098 71 5434001
Email
m.fasele@jums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen fasele
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom Motahari Street. University campus site. nursing school
City
jahrom
Province
Fars
Postal code
7414846199
Phone
0098 71 5433001
Email
m.fasele@jums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Send the request to the responsible author's email, and if necessary, the information will be available for meta-analysis
From where data/document is obtainable
09177924361 Mohsen fasele
What processes are involved for a request to access data/document
Send the request to the responsible author's email, and if necessary, the information will be available for meta-analysis
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