Comparing the effectiveness of shampoo containing Peganum harmala extract with permethrin shampoo in reducing symptoms and treating patients with head lice
Design
A clinical trial with a control group, with parallel groups, double blinded, randomized, phase 2 on 40 patients. The RAND function of Excel software is used for randomization.
Settings and conduct
The clinical trial in phase 2 will be conducted on 40 patients in Razi Hospital. After signing the consent form by the patient or their parents, the quality of life questionnaire will be completed by the patients at the beginning and end of the treatment. The patient of the first group uses the Wild rue shampoo product twice a day and every time by smearing all the involved areas the scalp and neck, for three continuous days. And after ten minutes with a softening shampoo. He washes his head and neck. The patient of the second group uses permethrin shampoo for ten minutes and then washes and uses a softener. At the end of the treatment, the improvement of the patient's symptoms is based on the Likert scale of 0 It is scored up to 10.
Participants/Inclusion and exclusion criteria
Patients with head lice are between the ages of 7-65 years old and have not recently received oral or topical treatments for head lice.
These patients must sign a consent form. In case of sensitivity to any of the components of the product, the candidate will be prevented from entering the study.
Intervention groups
1- The group receiving Esfand shampoo 1% 2- The group receiving Permethrin shampoo 1%
Main outcome variables
Symptoms status of patients with head lice and its amount
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160306026938N20
Registration date:2024-08-27, 1403/06/06
Registration timing:registered_while_recruiting
Last update:2024-08-27, 1403/06/06
Update count:0
Registration date
2024-08-27, 1403/06/06
Registrant information
Name
Mahdi Vazirian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1223
Email address
vazirian_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-24, 1403/06/03
Expected recruitment end date
2024-10-24, 1403/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical efficacy investigation and comparison of shampoo containing Peganum harmala extract and permethrin shampoo in patients with head lice
Public title
Effectiveness of Wild rue shampoo in the treatment of head lice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conformity with head lice diagnostic criteria.
Age range between 7 and 65 years.
Being in healthy condition
Signing informed consent form for adults and parental consent form for children
Not using local or systemic anti-lice products during the recent infection
Exclusion criteria:
Local or systemic anti-lice treatment or use of hair dye during or before the study period
Having serious diseases or extensive wounds, especially in the scalp area (such as impetigo or eczema), chronic scalp disorders (such as psoriasis, chronic dermatosis)and secondary scalp infection
Known allergy to any of the components of the product
Treatment with antibiotics (cotrimoxazole, trimethoprim, tetracycline) or anti-worm (such as ivermectin, levamisole, albendazole) in the last 1 month or other local or systemic drugs that may lead to errors in the test.
Age
From 7 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the Random number generation plugin in Excel software, a table of random numbers from 1 to 40 is prepared in a non-sequential and scattered manner, and intervention and control are done by assigning numbers to two groups of 20 people. The randomization process is done by the study methodology consultant, and the clinical researchers do not know about the randomization process, and only randomized codes from 1 to 40 will be provided to them.
Blinding (investigator's opinion)
Single blinded
Blinding description
The shampoo containing Peganum harmala extract and permethrin is poured by a third party in containers with the same shape, only with the identifying code label and will be given to the researcher and then to the participants. Due to the difference in the smell of peganum extract and permethrin, only the researcher is unaware of the contents of the drug and the patient notices this difference.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reasearch Ethichs Committees The Institute of Pharmaceutical Science-Tehran University of Medical
Street address
16 Azar Avenue, Tehran University of Medical Science, Faculty of Pharmacy, The Institute of Pharmaceutical Science, 2nd floor , unit 1-219.
City
tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-07-06, 1403/04/16
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.062
Health conditions studied
1
Description of health condition studied
head lice
ICD-10 code
B85.0
ICD-10 code description
Pediculosis due to Pediculus humanus capitis
Primary outcomes
1
Description
Lice levels
Timepoint
Before the initiation of intervention and the day after the last application of formulation
Method of measurement
Scoring the patients' symptoms based on a 0-10 Likert scale with regard to improvements in symptoms(0=no improvement; 10=complete improvement)
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the start of the intervention and one day after the last use of the formulation
Method of measurement
Completion of a 30-question questionnaire on the quality of life of head lice patients by the patient
Intervention groups
1
Description
Intervention group: The recipient of shampoo containing Peganum harmala extract. Patients use the Peganum harmala shampoo product once a day and every time by smearing all the affected areas and the scalp and neck, for three continuous days, and after ten minutes, they wash the head and neck with a softening shampoo.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group use 1% permethrin shampoo, so that they wash their hair with shampoo once and leave the shampoo on the patient's head for ten minutes, then wash it with water and use softener.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr. Zeinab Arianian
Street address
Razi hospital , Razi dead end, Vahdat-e-Eslami square, Vahdat-e-Eslami street
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 912 484 8444
Email
razihospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Fotohi
Street address
Central organization of Tehran University of Medical Science, Corner of Qods street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Fax
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Room No. 1-206, Second Floor, Old building, Faculty of Pharmacy, 16th Azar Ave, Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6412 1223
Email
Vazirian_m@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
Room No. 1-206, Second Floor, Old Building , Faculty of Pharmacy,16th Azar Ave, Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6412 1223
Email
Vazirian_m@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi vazirian
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
Room No. 1-206, Second Floor, Old building, Faculty of Pharmacy , 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6412 1223
Email
Vazirian_m@tums.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
Undecided - It is not yet known if there will be 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
Yes - There is 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
Demographic specification of patients, would be published, expect their names and address. Primary outcome of the patients would be published, too.
When the data will become available and for how long
Data would be available 6 months after publishing the results.
To whom data/document is available
data would be available for researchers in academic and scientific organisations
Under which criteria data/document could be used
any type of usage of data is allowable, except using for manufacturing a product.
From where data/document is obtainable
Sending an E mail to mehdivazirain@gmail.com
What processes are involved for a request to access data/document
After receiving E. mail, data would be sent within a week