]>
IRCT20240614062125N1 IRCT 2024-07-29 Ahvaz University of Medical Sciences Treating Eczema in Children Comparison of the efficacy of hydrocortisone ointment and flax seed oil on skin eczema of children: A clinical trial study 2024-08-15 anticipated 92 Complete https://irct.ir/trial/77422 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study will employ a randomized controlled trial (RCT) design. Participants will be recruited and randomly assigned to either the test group (N=46) or the control group (N=46) using a randomized permutation method. This ensures that any observed differences in treatment outcomes are more likely due to the intervention rather than pre-existing differences between the groups, Randomization description: The research sample was first selected from the research community based on the inclusion criteria. Random assignment to the two test and control groups will be conducted using a blocked randomization technique with four permutation blocks (selected from a table of 24 possible blocks). This method ensures that the number of participants in each group is nearly equal. Blocks are formed based on relevant variables, and within each block, half are assigned to the test group and half to the control group. This approach aims to achieve balanced group sizes, Blinding description: Double-blind Randomized Clinical Trial The study employs a double-blind randomized controlled trial (RCT) design to minimize bias and ensure the objectivity of the results. This means that neither the participants (children) nor the researchers administering the treatments know which group a participant belongs to. Randomization and Group Allocation Participants are randomly assigned to either the test group (flaxseed oil) or the control group (hydrocortisone ointment) using a randomization process. Treatment Preparation and Masking To maintain blinding, both the flaxseed oil and hydrocortisone ointment are prepared in identical containers and labeled with neutral codes (e.g., "H" for hydrocortisone, "T" for flaxseed oil) by an independent person not involved in the treatment assignment or data collection. Double-blinding Implementation The coded containers are then distributed to the participants according to their group assignment. Researchers who interact with the participants and collect data are also blinded to the treatment groups. This ensures that neither the participants' expectations nor the researchers' assessments are influenced by the knowledge of which treatment a participant is receiving. N/A Eczema. Intervention 1: "Intervention group": Children in the test group will receive linseed oil according to dosage instructions and weight-based adjustments. Intervention 2: "Control group:" The control group uses hydrocortisone ointment. Also, the use of hydrocortisone ointment is done according to the doctor's recommendations and valid instructions for the control group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public AshrafalSadat Hakim
Jundishapur University of Medical Sciences, Esfand St., Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6173333183 +98 61 3373 8331 hakim3448200@yahoo.com Ahvaz University of Medical Sciences scientific AshrafalSadat Hakim
Jundishapur University of Medical Sciences, Esfand St., Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6173333183 +98 61 3373 8331 hakim3448200@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Children with eczema symptoms. Age of the child between 2 months and 24 months. No history of uncontrolled underlying disease. Parents have the ability to receive education (at least elementary literacy level). Parents have not participated in a previous class. 2 months 24 months Both Children under 2 months and over 24 months L20.8 Other atopic dermatitis Treatment - Drugs Treatment - Drugs "Intervention group": Children in the test group will receive linseed oil according to dosage instructions and weight-based adjustments. "Control group:" The control group uses hydrocortisone ointment. Also, the use of hydrocortisone ointment is done according to the doctor's recommendations and valid instructions for the control group. Skin dryness. Timepoint: Baseline (before intervention) and weeks 1, 2, and 3 following the start of treatment with flaxseed oil or hydrocortisone ointment. Method of measurement: Distance measurement: The distance from the "No dryness" end to the participant's mark is measured, often in millimeters.Higher scores = more dryness: A greater distance indicates a higher level of perceived skin dryness. Stretch marks. Timepoint: Baseline (before intervention) and weeks 1, 2, and 3 following the start of treatment with flaxseed oil or hydrocortisone ointment. Method of measurement: Visual Analogue Scale : We could simply count the total number of stretch marks present in the affected area at each time point. The length and width of individual stretch marks could be measured to assess their size. Skin healing. Timepoint: Baseline (before intervention) and weeks 1, 2, and 3 following the start of treatment with flaxseed oil or hydrocortisone ointment. Method of measurement: Visual Analogue Scale for Improvement: The Visual Analogue Scale could be adapted to capture the participant's perception of their skin healing progress. The scale could be labeled with descriptors like "No improvement" on one end and "Completely healed" on the other. Participants would mark the point that best reflects their current state of skin healing. Ahvaz University of Medical Sciences Approved 2024-06-01 Ethics Working Group in University Research Jundishapur University of Medical Sciences, Esfand Street, Golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)