Evaluation of the effecacy of aformulatuon from Peganum harmala aqueous extract on patients with head lice
Design
Clinical trial without control group and randomization, in phase 2, on 25 patients
Settings and conduct
The clinical trial is conducted in phase 2 on 25 patients in Razi Hospital. After signing the consent form, the quality of life questionnaire is completed by the patients at the beginning and at the end of the treatment. At the end of the treatment, the patients' symptoms is scored based on the Likert scale from 0 to 10. The patient applies the product once a day, each time by smearing all the involved areas and skin of the head and neck, for three consecutive days, and after ten minutes, he washes the head and neck with a softening shampoo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Compliance with head lice diagnostic criteria; age range between 18-65 years; signing the informed consent
Exclusion criteria: Having serious diseases or extensive skin wounds; Allergy to the components of the product; Antibiotic or anthelmintic treatment in the last 1 month
Intervention groups
Intervention group: including 25 people who apply the gel formulation containing Peganum harmala extract on a daily basis for 3 consecutive days
Main outcome variables
Lice affection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160306026938N12
Registration date:2022-10-18, 1401/07/26
Registration timing:prospective
Last update:2022-10-18, 1401/07/26
Update count:0
Registration date
2022-10-18, 1401/07/26
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
2022-12-12, 1401/09/21
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of a formulation of Peganum harmala aqueous extract on patients with head lice
Public title
Evaluation of efficacy of Peganum harmala extract on patients with head lice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conformity with head lice diagnostic criteria
Age range between 18 and 65 years
Signing informed consent
Being in healthy condition
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 anthelmintics (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 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethichs Committees of The Institute of Pharmaceutical Sciences- Tehran University Of Medica
Street address
16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219،
City
tehran
Province
Tehran
Postal code
1417613151
Approval date
2022-09-20, 1401/06/29
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.050
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: recipient of gel formulation containing aqueous extract of Peganum harmala plus carbomer and sodium hydroxide. In three consecutive days, once a day, the patient smears all the infected areas and the skin of his head and neck with gel and after ten minutes, he washes the stained areas with softening shampoo and water.
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 Sciences, Corner of Qods street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
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 buliding, 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 buliding, 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 buliding, 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
Yes - There is 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
En Demographic specification of patients, would be published, except their names and address. Primary outcome of the patients would be published, too.
When the data will become available and for how long
En 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 mehdivazirian@gmail.com
What processes are involved for a request to access data/document
After receiving E. mail, data would be sent within a week