Evaluating the efficacy of a herbal shampoo on head lice.
Design
Eligible participants will be randomly assigned to either intervention group 1 or 2 using simple randomization.
Based on previous studies and considering a confidence level of 95% and statistical power of 80%, the required sample size is estimated to be 60 participants.
Trial phase: Phase 2 clinical trial
Settings and conduct
Study site: Shahid Sadoughi Hospital
Group allocation: Intervention group 1 (herbal shampoo) and intervention group 2 (permethrin shampoo)
Intervention: The entire hair and scalp will be covered with the assigned shampoo for seven consecutive days, with each application lasting one hour.
Follow-up: Assessment of the presence of live lice in the hair before treatment, three days after starting treatment, and one week after starting treatment. Assessment of the presence of lice eggs in the hair and counting the number of eggs attached to the hair before treatment, three days after starting treatment, and one week after starting treatment. Evaluation of skin itching.
Blinding: This study will be conducted in a double-blind manner. This means that both the participants and the research team will be blind to the type of shampoo used by each participant.
Participants/Inclusion and exclusion criteria
Participants: Patients with head lice. Study entry requirements: Presence of head lice, completion of clinical consent form by patient. Study exclusion criteria: Failure to attend follow-up, unwillingness to cooperate for any reason
Intervention groups
Intervention group 1: Treated with herbal shampoo
Intervention group 2: Treated with permethrin shampoo
Main outcome variables
The number of live lice visible on the scalp after one week of intervention;
The number of lice eggs after one week of intervention;
The severity of scalp itching (based on the Visual Analog Scale - VAS) after one week of intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240804062634N1
Registration date:2024-08-21, 1403/05/31
Registration timing:prospective
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
Hadi Zare-Zardini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3183 4264
Email address
hzare@meybod.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of herbal shampoo containing Gharaghorot, vinegar and ajwain on head lice: a clinical trial study
Public title
Effect of herbal shampoo on head lice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Head lice infestation
Completion of the informed consent form by the patient
Exclusion criteria:
Failure to follow up
Lack of cooperation due to any reason
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a simple method with fixed-size blocks (4 to 6) is used. Each participant is randomly assigned to one of the two groups (intervention or control). The random sequence is generated using Stata software. To ensure blinding of the allocation, the random sequence is generated and held by a person other than the investigator.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was designed as a double-blind trial, in which both the participants and the healthcare personnel administering the shampoo to the patients and collecting data and evaluating outcomes will be blinded to the type of shampoo.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
SShahid Sadoughi University of Medical Sciences
Street address
Central Building, Shahid Sadoughi University of Medical Sciences, Bahonar Street
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.SSU.REC.1402.026
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
Presence of live lice in the hair: Assessment of the presence of live lice in the hair before treatment, three days after starting treatment, and one week after starting treatment.
Timepoint
Before starting treatment, three days after starting treatment, and one week after starting treatment.
Method of measurement
Visual and microscopic examination of the patients' scalp hair. The use of a comb and a fine-toothed comb to separate the hair and a microscope to confirm the presence of lice.
2
Description
Presence of lice eggs in the hair: Counting the number of eggs attached to the hair in a 25 cm² area before starting treatment, three days after starting treatment, and one week after starting treatment.
Timepoint
Before starting treatment, three days after starting treatment, and one week after starting treatment.
Method of measurement
Visual and microscopic examination of the patients' scalp hair. The use of a comb and a fine-toothed comb to separate the hair and a microscope to confirm the presence of nits. Counting the number of eggs attached to the hair within a 25 cm² area.
3
Description
Skin itching side effect: Assessment of skin itching in patients of both groups at different time points (before treatment, three days after starting treatment, one week after starting treatment).
Timepoint
Before starting treatment, three days after starting treatment, and one week after starting treatment.
Method of measurement
Patient history and standardized questionnaire:A standardized questionnaire will be used to assess the severity of scalp itching.Tool: Standardized questionnaire for evaluating scalp itching.Scale: Visual Analogue Scale (VAS) using facial expressions will be used to assess the severity of scalp itching.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Treated with herbal shampoo. In this group, an herbal shampoo produced by Yas Navid Company (containing Gharaghorot, vinegar and ajwain) will be used. The patient will soak their entire hair and scalp with the mentioned shampoo for one hour daily for seven consecutive days.
Category
Treatment - Other
2
Description
Intervention group 2: In this group, a permethrin shampoo produced by Irox Company (containing 1% permethrin) will be used. The patient will soak their entire hair and scalp with the mentioned shampoo for one hour daily for seven consecutive days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Hadi Zare-Zardini
Street address
Shahid Ghandi Street, Ibn Sina Street
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
hadizarezardini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi-Abargouei
Street address
Bahonar Street
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3724 0171
Email
abargouei@ssu.ac.ir
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
Hadi Zare-Zardini
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Shahid Sadoughi Hospital, Ibn Sina Street, Shahid Ghandi Street
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
hzare@meybod.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hadi Zare-Zardini
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Shahid Sadoughi Hospital, Ibn Sina Street, Shahid Ghandi Street
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
hzare@meybod.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hadi Zare-Zardini
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Shahid Sadoughi Hospital, Ibn Sina Street, Shahid Ghandi Street
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
hzare@meybod.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data related to the primary outcomes of this study will be shared.
When the data will become available and for how long
Access to the data will be granted 6 months after publication of the results.
To whom data/document is available
Researchers employed in academic and scientific institutions
Under which criteria data/document could be used
Raw data will be provided to researchers for their use in further analysis
From where data/document is obtainable
Yazd, Safaieyeh, Shahid Ghandchi Boulevard, Ibn Sina Street, Shahid Sadooqi Hospital, Oncology Building, Sadeghian, Basement, Blood and Cancer Research Center, Hadi Zarrin-Zardini
Postal Code: 8915887857
Phone: 00989137089212
What processes are involved for a request to access data/document
Submission of a request via academic email - Review by the Research Council of the Research Center - Issuance of approval, Submission of data to the applicant.