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IRCT20141124020073N3 IRCT 2022-02-20 Esfahan University of Medical Sciences Effect of acyclovir-melissa nanofiber patch in treatment of recurrent herpes labialis Comparison of remission index of nanofiber loading acyclovir- melisa and nanofiber loading acyclovir and mucoadhesive cream formula on Recurrent-Herpes-Labialis 2021-09-11 anticipated 80 Complete https://irct.ir/trial/60765 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The selected patients were randomly divided into four groups. The first group received a pack containing 15 acyclovir 5%-Melissa 1% nanopatches; the second group received a tube containing acyclovir 5%-Melissa 1% cream; the third group received 15 nanopatches of acyclovir 5%; and the fourth group received acyclovir 5% cream. Considering small recruited sample size and for overall balance reasoning between the four study arms, the recruited patients were randomized employing permuted block randomization method with a block size of 4, Blinding description: The patients and the clinicians were unaware about the content of the packages containing nanofiber patches and the creams. 3 Recurrent Herpes Labialis. Intervention 1: Intervention group: acyclovir-melissa nanofiber patch: Active ingredients are acyclovir in the class of antiviral drugs, and Melissa Officinalis a herb containing polyphenolic compounds with anti-inflammatory and anti-viral properties. main chemical composition consists of polyvinyl alcohol polymer, acyclovir5% and melissa1%, made in "Rahesh Daruye Novin" company, used once in a day for 5 days at the site of the lesion. Intervention 2: Intervention group: acyclovir-melissa cream: Active ingredients are acyclovir5% in the class of antiviral drugs, and Melissa Officinalis1% a herb containing polyphenolic compounds with anti-inflammatory and anti-viral properties, made in "Iran Daru" pharmaceutical company, used three times in a day for five days at the site of the lesion. Intervention 3: Intervention group: acyclovir nanofiber patch: Active ingredient is acyclovir in the class of antiviral drugs, main chemical composition consists of polyvinyl alcohol polymer and acyclovir, made in "Rahesh Daruye Novin" company, used once in a day for 5 days at the site of the lesion. Intervention 4: Intervention group: acyclovir cream 5%, Active ingredient is acyclovir in the class of antiviral drugs, made in "Iran Daru" pharmaceutical company, used three times in a day for five days at the site of the lesion. Yes - There is a plan to make this available What will be shared: Individual data of study participants can be shared after unidentifying individuals When: The access period starts from the time the results are printed To whom: The data will be available to researchers working in academic and scientific institutions Conditions: The use of participants' personal data and study documents is allowed only for scientific purposes and study simulation Where to obtain: To access the data, refer to the person in charge of updating the information. How to obtain: If necessary, the applicant sends an email to the person in charge of updating the information, requesting access to the data file, and the data will be sent to the applicant's email within 1 to 2 days. Comments:
public zahra Golestannejad
Isfahan University of Medical Sciences, Hezar Jerib st.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5515 golestannejad@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Zahra Golestannejad
Isfahan University of Medical Sciences, Hezar Jerib st
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5515 golestannejad@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Maximum interval of 48 hours since the emergence of the lesion Having a recurrent lesion (i.e., secondary) Receiving no antiviral, anti-inflammatory, steroid, or analgesic drugs Vesicular stage of the lesion and lesion size <1 cm 18 years 60 years Both Allergies to the used herbal medicines Hepatic, renal, or systemic diseases Use of birth control pills Breastfeeding B00.1 Herpesviral vesicular dermatitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: acyclovir-melissa nanofiber patch: Active ingredients are acyclovir in the class of antiviral drugs, and Melissa Officinalis a herb containing polyphenolic compounds with anti-inflammatory and anti-viral properties. main chemical composition consists of polyvinyl alcohol polymer, acyclovir5% and melissa1%, made in "Rahesh Daruye Novin" company, used once in a day for 5 days at the site of the lesion Intervention group: acyclovir-melissa cream: Active ingredients are acyclovir5% in the class of antiviral drugs, and Melissa Officinalis1% a herb containing polyphenolic compounds with anti-inflammatory and anti-viral properties, made in "Iran Daru" pharmaceutical company, used three times in a day for five days at the site of the lesion Intervention group: acyclovir nanofiber patch: Active ingredient is acyclovir in the class of antiviral drugs, main chemical composition consists of polyvinyl alcohol polymer and acyclovir, made in "Rahesh Daruye Novin" company, used once in a day for 5 days at the site of the lesion Intervention group: acyclovir cream 5%, Active ingredient is acyclovir in the class of antiviral drugs, made in "Iran Daru" pharmaceutical company, used three times in a day for five days at the site of the lesion Symptoms of patient discomfort (pain, itching, burning sensation). Timepoint: Daily measurement of the symptoms from the beginning of treatment (baseline) until the symptoms disappeared. Method of measurement: Using a numerical scale, ranging from 0 to 10. Crusting time. Timepoint: As soon as evidence of crusting was observed in the daily images taken and sent by patients, the patient was referred for clinical examinations. Method of measurement: Clinical examination. Healing time. Timepoint: As soon as evidence of healing was observed in the images, the patient was referred for clinical examinations. Method of measurement: Clinical examination. Esfahan University of Medical Sciences Approved 2021-02-28 Research ethics committee of Isfahan University of Medical Sciences Vice counselor for research and technology, Isfahan University of Medical Sciences, Hezar jerib St. Isfahan Isfehan Iran (Islamic Republic of)