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IRCT20210209050303N1 IRCT 2022-06-10 Mashhad University of Medical Sciences The effect of green tea extract in the treatment of warts The effect of green tea extract (sincathecin) in the treatment of patients with common and palmoplantar warts referred to the dermatology clinic of Imam Reza Hospital in Mashhad and its comparison with the control group 2022-04-18 anticipated 80 Complete https://irct.ir/trial/54219 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study in three stages: 1- creating a random sequence, 2- hidden Random allocation is made and the randomization process is executed. 1- Creating a random sequence: Web-based randomization is used to generate a random sequence. Sequences of random numbers are generated with the help of https://kitset.ir/numbers/random. 2- Random allocation concealment: The method and tool used to perform a random sequence on the study participants is the use of opaque envelopes sealed with a random sequence. Each random sequence created is recorded on a card and the cards are placed in the envelopes of the order, respectively. Patients who meet the inclusion criteria are randomly assigned to one of the two groups. In this way, at the time of registration of the participants, based on the order of their entry into the study, one of the envelopes of the letter is opened in order and the assigned group of that participant is revealed. 3- Execution of random allocation process A: Identify the person who creates the random sequence. B: Designate a person who evaluates and registers patients in terms of inclusion and exclusion criteria. C: Determine the person who assigned the participants to the groups. The person creating the random sequence is not involved in other stages of randomization, including registration and assignment of participants, and the person involved in creating the random program is separate from other researchers, Blinding description: The physician responsible for evaluating the results in the patients and the person in charge of the study analysis are unaware of the patients' assignment to the type of treatment. Blinding patients is not possible due to the type of intervention. N/A Viral warts. Intervention 1: The intervention group is treated topically with green tea extract three times a day with an interval of 8 hours for 16 weeks. The green tea extract used in this study is prepared by a pharmacologist from green tea leaves and contains 15% syncatin. Intervention 2: The control group is treated with cryotherapy using liquid nitrogen once every two weeks until complete healing of the lesions. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Moghadase Jafari
Dermatology Clinic, Imamreza Hospital, Daneshgah Street, Mashhad, Iran
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3802 2031 jafarimg971@mums.ac.ir Mashhad University of Medical Sciences scientific Moghadase Jafari
Dermatology Clinic, Imamreza Hospital, Daneshgah Street, Mashhad, Iran
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3802 2031 jafarimg971@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) People 15 to 35 years old with common and palmoplantar warts who are otherwise healthy 15 years 35 years Both Pregnant and lactating women Patient with immunodeficiency patient with underlying diseases patient with a history of skin disease or allergies to certain topical or systemic medications B07 Viral warts Treatment - Drugs Treatment - Devices The intervention group is treated topically with green tea extract three times a day with an interval of 8 hours for 16 weeks. The green tea extract used in this study is prepared by a pharmacologist from green tea leaves and contains 15% syncatin. The control group is treated with cryotherapy using liquid nitrogen once every two weeks until complete healing of the lesions. Total wart area. Timepoint: Measurement of wart lesion area at the beginning of the study (before the intervention) and the first month, second month, third month and fourth month after starting to use green tea extract. Also three months and 6 months after the end of treatment. Method of measurement: Ruler. Localized Adverse reactions. Timepoint: Once every two weeks. Method of measurement: Telephone history, observation of complications. Mashhad University of Medical Sciences Approved 2022-04-12 Working Group / Ethics Committee in Research, School of Medicine, Mashhad University of Medical Scie Imam reza hospital, Mashad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)