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Study aim
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Assessing and comparing the effectiveness of gels containing green tea extract, a mixture of green tea extract and Peganum harmala seed extract (in a 50-50 ratio), and a mixture of green tea extract and Peganum harmala seed extract (in an 80-20 ratio) in the treatment of genital warts in women.
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Design
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A phase 2 randomized, double-blind, 3-arm, parallel-group clinical trial in 60 patients with genital warts. Randomization with https://www.sealedenvelope.com
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Settings and conduct
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Patients referred to Ghaem hospital, Mashhad by the researcher will be selected if they meet the inclusion and exclusion criteria will enter the random allocation process. In each group, the desired gel is applied three times a day by the patient at home on the lesion at a rate of 2 mm, and the patients are followed up by the researcher by phone once a week to ensure drug use. All three groups of patients are referred for follow-up every two weeks, and the gel box is weighed with a digital scale to ensure drug use by the patient. Then, the lesions are measured by the researcher, and the presence of unwanted inflammatory reactions such as burning, itching, redness, pain, and erosion, severity during the period, is recorded.
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Participants/Inclusion and exclusion criteria
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Women aged 18 to 50 years with external genital warts who do not have allergies to green tea or Peganum harmala seed extract and are not infected with any other sexually transmitted diseases.
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Intervention groups
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Three treatment groups: 1- gel containing green tea extract as the standard treatment,2- gel containing green tea extract and Peganum harmala seed extract in a 50-50 ratio, 3-gel containing green tea extract and Peganum harmala seed extract in an 80-20 ratio.
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Main outcome variables
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Number, size and location, time of onset of lesions, presence of clinical symptoms associated with lesions
Visit every two weeks