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

Evaluation of the effect of green tea extract (Sinecatechins) in the treatment of common warts (palmoplantar) and its comparison with cryotherapy

The clinical trial has an intervention group and a control group in parallel, one-way, blinded, randomized, on 80 patients, which uses the envelope method for randomization.

This study is performed in the dermatology clinic of Imam Reza Hospital in Mashhad, Khorasan Razavi Province, Iran. During the initial visit, the patients' demographic information, previous records, are examined and examinations are performed, and the size, shape, number and location of the lesions are recorded, and photographs of the lesions are taken. During the treatment period, patients are visited every month and their lesions will be evaluated by photographing and comparing with the initial recorded images. Also, once every two weeks, patients are evaluated for drug side effects and local sensitivity. Treatment of the cured patients is stopped and they will be visited again one and three months later to check for possible recurrence.

Patients referred to the dermatology clinic of Imam Reza Hospital, who have at least one normal non-genital wart of both men and women, who are 15 to 35 years old and are otherwise healthy, are included in the study. People with underlying disease, immunodeficiency, and pregnant and lactating people, as well as people with a history of skin disease or allergy to a specific topical or systemic drug, will not be included in the study.

The intervention group was treated topically with green tea extract containing 15% Sinecatechins three times a day for 8 hours for 16 weeks. For the control group, cryotherapy is performed every two weeks until complete healing of the lesions.

Total wart area; Localized Adverse reactions

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.

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.

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The study protocol, statistical analysis map and clinical study report will be fully shared.

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Dr. Moghadase Jafari jafarimg971@mums.ac.ir

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