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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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. .
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Main outcome variables
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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