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IRCT20160821029446N6 IRCT 2020-03-24 Tehran University of Medical Sciences The Effect of Honey Ointment on the Pain Severity and Healing of Women Genital Herpes Lesions. The Effect of Honey Ointment on the Pain Severity and Healing of Women Genital Herpes Lesions. 2020-05-20 anticipated 68 Complete https://irct.ir/trial/45822 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly divided into two groups of intervention and control, so that we first design 4 blocks of different types of probability, so that in each block two of the intervention group and two of the control group will be placed. The number of possibilities in this case will be 6. Then create a list of random numbers between 1 and 6 and arrange the blocks according to the list of numbers obtained until the total number of samples is covered. Accordingly, individuals are divided into two groups. The intervention group will be the group that will take oral acyclovir with honey ointment and the control group will be the group that will take oral acyclovir with placebo, Blinding description: This Study will be a Randomized Controlled Trial, Triple-blind, Placebo-Controlled Clinical Trial. The Drugs are already divided by the Pharmacist. How to get Blind is that the Participants, the Researcher, and the Statistics Consultant are Unaware of the Type of Drug being Administered, and both Drugs are provided in identical formats and with specific codes by the Pharmacist and are provided to research units. Participants and Researcher will not be aware of the Drug codes, only the Pharmacist will determine the Drug code, and will be decrypted after the Data is collected and completed. The dose of Acyclovir in both groups will be the same as prescribed. 3 genital herpes. Intervention 1: Intervention group: This group will take oral aciclovir 400 mg 3 times daily for 7-10 days or until clinical symptoms resolve, with honey ointment 5 times daily until the skin returns to normal or up to 10 Day (whichever happened earlier). Initial clinical evaluation will be done at the time of enrollment (day zero) and severity of pain and lesion will be recorded and repeated on days 7 and 10. Intervention 2: Control group: This group will take oral aciclovir 400 mg 3 times daily for 7-10 days or until clinical symptoms resolve, with Placebo ointment 5 times daily until the skin returns to normal or up to 10 Day (whichever happened earlier). Initial clinical evaluation will be done at the time of enrollment (day zero) and severity of pain and lesion will be recorded and repeated on days 7 and 10. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Shahnoush Gerami
School of Nursing & Midwifery, Tehran University of Medical sciences, Tohid Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 sh.gerami1990@gmail.com Tehran University of Medical Sciences scientific Maryam Damghanian
Nursing and Midwifery Faculty,Tehran University of Medical Sciences,Tohid Square,Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733172 +98 21 6692 7171 Maryam_damghanian@ yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Initial Herpes Genital Needs treatment for active Wounds Non-use of effective medications for Wound Healing (Anticoagulants, Anti-depressant, Alcohol, Glucocorticoids, immunosuppressive drugs, Chemotherapy, drugs, Psychotropic drugs) Lack of disease that disrupts Wound Healing (Chronic systemic diseases, Heart disease, kidney disease, Lung disease,  Coagulopathy, Immune deficiency,Connective tissue disorder,  Diabetes, Anemia, mental illnesses, hemophilia, Depression,  Malnutrition) Lack of Pregnancy or Lactation no limit no limit Female Treatment - Drugs Treatment - Drugs Intervention group: This group will take oral aciclovir 400 mg 3 times daily for 7-10 days or until clinical symptoms resolve, with honey ointment 5 times daily until the skin returns to normal or up to 10 Day (whichever happened earlier). Initial clinical evaluation will be done at the time of enrollment (day zero) and severity of pain and lesion will be recorded and repeated on days 7 and 10. Control group: This group will take oral aciclovir 400 mg 3 times daily for 7-10 days or until clinical symptoms resolve, with Placebo ointment 5 times daily until the skin returns to normal or up to 10 Day (whichever happened earlier). Initial clinical evaluation will be done at the time of enrollment (day zero) and severity of pain and lesion will be recorded and repeated on days 7 and 10. Severity of Pain. Timepoint: At the beginning of the study and 7 and 10 days after intervention. Method of measurement: VAS tool. Healing of lesions. Timepoint: At the beginning of the study and 7 and 10 days after intervention. Method of measurement: Observation and Ruler. Tehran University of Medical Sciences Approved 2020-02-12 Ethics Committee of Nursing and Midwifery and Rehabilitation Faculty of Tehran University of Medical Nursing and Midwifery Faculty of Tehran University of Medical Sciences, Tohid Square, Tehran Tehran Tehran Iran (Islamic Republic of)