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Evaluation of efficacy of Peganum harmala extract on patients with head lice

Phase 2
Conditions
Head lice.
Pediculosis due to Pediculus humanus capitis
B85.0
Registration Number
IRCT20160306026938N12
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
25
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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ice 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 Outcome Measures
NameTimeMethod
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.
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