Protocol summary

Study aim
Determining the effect of a topical herbal product based on olive oil containing essential oils of two plants myrtle and oregano and combining it with dietary recommendations in patients with treatment-resistant head lice.
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 90 patients. The randomization process was done using the online computerized random allocation sequence and through the dedicated website (https://www.sealedenvelope.com/) of the randomization process.
Settings and conduct
The required sample size for each group will be 30 people. After selecting girls' primary schools with a simple random method, students with pediculosis resistant to disease treatment are included in the study. The patients are divided into three groups, the control group is treated with 4% dimethicone lotion twice with an interval of seven days, and the first intervention group takes the medicine three times with an interval of seven days, and the third group receives the medicine and dietary recommendations.
Participants/Inclusion and exclusion criteria
Female children with head lice who have not improved with two consecutive courses of treatment; insensitivity to plant essential oils; age 6 to 12 years old; no history of asthma, allergies and skin allergies according to the parents' report; absence of chronic skin disease.
Intervention groups
Patients are randomly divided into three groups: the control group receives 4% dimethicone lotion twice with an interval of seven days, the first intervention group receives a topical herbal product three times with an interval of seven days, and the third group receives medication and dietary recommendations. .
Main outcome variables
1-The rate of complete recovery based on examination 2-Assessing the severity of pruritus 3-Evaluation of dryness, redness, scaling and irritation to the extent of complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240501061615N1
Registration date: 2024-08-26, 1403/06/05
Registration timing: prospective

Last update: 2024-08-26, 1403/06/05
Update count: 0
Registration date
2024-08-26, 1403/06/05
Registrant information
Name
Afsaneh Mirshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 0000 0000
Email address
mirshahia5@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Topical Herbal Product Based on Olive Oil and Dietary Recommendations Based on Persian Medical Resources in Patients with Resistant Head Lice Treatment
Public title
Investigating the effect of an oil product containing essential oils of two plants and oregano on treatment-resistant head lice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female children with head lice who have not improved with two consecutive courses of treatment Parents' willingness to cooperate in the plan Insensitivity to plant essential oils Accessibility during research Age 6 to 12 years old No history of asthma, allergies and skin allergies according to the parents' report Absence of chronic skin disease
Exclusion criteria:
Allergy history Reluctance to cooperate Allergy to oregano and myrtle
Age
From 6 years old to 12 years old
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible people are randomly assigned to the groups under study (the herbal product consuming group, the herbal product consuming group with dietary recommendations, and the control group) in a simple random manner and in a ratio of 1:1:1. The randomization process will be done using the online computerized random allocation sequence and through the dedicated website of the randomization process. Allocation of individuals/patients (Randomization) to the groups under study will be hidden for the patient, physician/interventionist, and outcome assessor (allocation concealment). In this way, the belonging of the people to the groups under study is marked on the paper/card and placed inside the opaque envelopes so that its contents cannot be seen from the outside. During the visit of the eligible patient for the study, the attending physician takes one of the envelopes and then opens it, and based on the contents of the envelope, the patient is placed in the intervention 1, intervention 2 or comparison/control group and treatment services are provided.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluators and analysts will be unaware of the intervention and control groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Second floor, Research and Technology Vice-Chancellor, Building number one of Mashhad University of Medical Sciences (Qureshi), in front of Daneshgah 18, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-04-13, 1403/01/25
Ethics committee reference number
IR.MUMS.REC.1403.002

Health conditions studied

1

Description of health condition studied
Pediculus humanus capitis
ICD-10 code
B85.0
ICD-10 code description
Pediculosis due to Pediculus humanus capitis Head-louse infestation

Primary outcomes

1

Description
The rate of complete recovery based on examination, visual visit, observation of the intention or adult lice and a questionnaire to determine the severity of the infestation
Timepoint
Examinations are generally performed 4 times upon arrival and on days 7, 14 and 21
Method of measurement
The rate of complete recovery based on examination, visual visit, observation of the intention or adult lice and a questionnaire to determine the severity of the infestation

Secondary outcomes

1

Description
Checking the severity of itching
Timepoint
Examinations are generally performed 4 times on arrival and on days 7, 14 and 21.
Method of measurement
By completing the questionnaire

2

Description
Examination of dryness in order to check complications
Timepoint
Examinations are generally performed 4 times on arrival and on days 7, 14 and 21.
Method of measurement
By completing the questionnaire

3

Description
Check for redness to check for complications
Timepoint
Examinations are generally performed 4 times on arrival and on days 7, 14 and 21.
Method of measurement
By completing the questionnaire

4

Description
Examination of skin irritation in order to investigate complications
Timepoint
Examinations are generally performed 4 times on arrival and on days 7, 14 and 21.
Method of measurement
By completing the questionnaire

Intervention groups

1

Description
Intervention group1:An oily herbal product containing the essential oils of two plants, Myrtus and oregano, will be taken topically three times at intervals of seven days. The hair is completely impregnated with the product and massaged for ten minutes, then covered with a hair cap for 2 hours, and then washed and dried with shampoo, and at the end of each treatment, an examination is done in terms of contamination and its severity.
Category
Treatment - Drugs

2

Description
Intervention group2: In addition to the oily herbal product prescribed in the first group, dietary recommendations based on traditional medicine sources were received in writing, according to the recommendations of Traditional Iranian Medicine, dietary recommendations provided to patients include avoiding the consumption of fast food, sausages, pasta, salads, high-fat foods, figs and berries, salads and yogurt with meals, consumption of liquids with and after meals, eating and Eating beef and veal during the treatment period and the examinations are the same as the first group.
Category
Treatment - Drugs

3

Description
Control group: The control group or the group that is considered as the standard group in this study is the people who will take Dimethicone 4% lotion twice with an interval of seven days. Apply dimethicone lotion to dry hair, from root to tip, then allow it to dry naturally, the lotion should be left on the head for at least 8 hours or overnight, then rinsed thoroughly with water and shampoo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital (AS) - Iranian and Complementary Medicine Clinic
Full name of responsible person
Mirshahi Afsaneh
Street address
Iranian and Complementary Medicine Clinic, Imam Reza (AS) Hospital, Ibn Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
mirshahia5@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
3rd floor, University Research and Technology Vice-Chancellor, , Mahshad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mirshahi Afsaneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Iranian and Complementary Medicine Clinic, Amlam Reza Research and Therapeutic Hospital, Ibn Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
mirshahia5@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salari Roshanak
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Drug control
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus,East Gate of Ferdowsi University of Mashhad ،Azadi Square,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Email
SalariR@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
MirshahiAfsaneh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Iranian and Complementary Medicine Clinic, Imam Reza (AS) Hospital, Ibn Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
mirshahia@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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
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