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IRCT20181114041652N1 IRCT 2019-05-26 Mashhad University of Medical Sciences Comparison of the effect of cream containing Green Tea Extract with Pedophilin solution in the treatment of Genital Warts in Women Comparison of the effect of cream containing Green Tea Extract with Pedophilin solution in the treatment of Genital Warts in Women 2018-12-22 anticipated 80 Complete https://irct.ir/trial/35222 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In the visits to follow up by the researcher, the measurements were made and the rate of reduction was lower than the initial size in percent and in each patient there were unwanted inflammatory reactions such as burning, itching, erythema, pain and erosion, as well as the severity of it during the course in the relevant form Registered by the researcher. In the absence of a complication, the score of zero, if there was a mild degree of any complication of score 1, in the mean intensity of score 2, and in case of severity of the 3rd, was attributed to each individual event. Patients treated by the researcher in three The scale is graded according to the percentage of reduction in lesions in terms of size and number indicating recovery rates. More than 91% (complete recovery), between 62 and 91% (moderate improvement), less than 62% (mild recovery), Randomization description: To randomize, we use the blocking method 4 with blocks of constant volume of 4 in two groups A and B.If there are two therapies, there will be six different blocks for the four blocks: 1)TTCC 2) TCTC 3) TCCT 4) CCTT 5) CTCT 6) CTTC We create random numbers between 0 and 600 with computer help. For numbers between 0 and 100/6(TTCC), we count the numbers between 100/6 200/6 (TCTC) and ... and continue this until we reach the desired sample size, Blinding description: In this study, considering that the drug is a control group of the solution and the intervention group is cream, so there is no possibility of blinding the research units, also as the control group is prescribed by the researcher, there is no possibility of blinding for the researcher, so only the possibility of blind data analysis There is. 3 Genital warts. Intervention 1: Intervention group: After the clinical diagnosis of lesions, in the intervention group, 10% cream of the green tea extract is performed three times a day for 12 weeks or until complete clearance. The cream is used by the patient at home and the patients are followed up by a researcher by phone one weekly and will be visited every two weeks to check lesions. standardization (Determine the amount of Dry Extract Powder) was performed based on Epigallocatechin. Formulation of topical preparation of green tea extract based on oil cream in water containing 19% Sinecatechin (7% Epigallocatechin). The components of the cream include dry extract of green tea, distilled water, glycerin, tween 89, cetyl alcohol, liquid paraffin and oeserin. Finally, a 10% cream containing green tea extract was prepared in 15 g tubes. The cream is used three times a day for 12 weeks or until complete clearance. Intervention 2: In Control group Pedophilin solution 10% is used once a week by the researcher for the patient up to 6 weeks or until complete clearance. In this study, pedophilein solution was prepared by the pharmacist's advisor at the Faculty of Medicine's Laboratory and administered as 10% solution once a week by The researcher will be used for the patient until complete clearance. To prevent damage to the healthy tissue of the skin, around the lesions، vaseline cream is used. 4 to 6 hours after application, the skin should be washed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no more information
public Seyede Zohreh Mousavi
faculty of Nursing and Midwifery, Ebnesina Ave.
Mashhad Iran (Islamic Republic of) 9913197319 +98 51 3869 1511 mousavizh962@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Golmakani
Factuly of Nursing and Midwifery, Ebnesina Ave.
Mashhad Iran (Islamic Republic of) 9913197319 +98 51 3859 1511 GolmakaniN@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Have written consent to participate in the research, Iranians living in Neyshabur or Mashhad, Age from 18 to 50 years, have literacy to read and write, Do not pregnant and breastfeed,His wife has no other wife, No previous marriage history, There is no specific drug use his, Patient with immunodeficiency disease, There is no history of skin sensitization and skin diseases, Do not smoke, No other STI infections are present, Her husband does not have genital warts,Use condoms during treatment, The number of lesions is between 2 and 30 lesions, The level of waste is between 12 and 600 mm cubic meters, Genital warts are limited to the skin Her husband does not have genital warts اصلاح شد 18 years 50 years Female It is susceptible to prescription. The patient does not want to continue to participate in the research،Pregnant during study, If it does not use more than 20% of the drug per week B07 Anogenital (venereal) warts A63.0 Treatment - Drugs Treatment - Drugs Intervention group: After the clinical diagnosis of lesions, in the intervention group, 10% cream of the green tea extract is performed three times a day for 12 weeks or until complete clearance. The cream is used by the patient at home and the patients are followed up by a researcher by phone one weekly and will be visited every two weeks to check lesions. standardization (Determine the amount of Dry Extract Powder) was performed based on Epigallocatechin. Formulation of topical preparation of green tea extract based on oil cream in water containing 19% Sinecatechin (7% Epigallocatechin). The components of the cream include dry extract of green tea, distilled water, glycerin, tween 89, cetyl alcohol, liquid paraffin and oeserin. Finally, a 10% cream containing green tea extract was prepared in 15 g tubes. The cream is used three times a day for 12 weeks or until complete clearance. In Control group Pedophilin solution 10% is used once a week by the researcher for the patient up to 6 weeks or until complete clearance. In this study, pedophilein solution was prepared by the pharmacist's advisor at the Faculty of Medicine's Laboratory and administered as 10% solution once a week by The researcher will be used for the patient until complete clearance. To prevent damage to the healthy tissue of the skin, around the lesions، vaseline cream is used. 4 to 6 hours after application, the skin should be washed Percentage recovery of genital warts. Timepoint: At weeks 2, 4, 6, 8, 10, 12 after starting treatment. Method of measurement: The percentage of reduction in lesions is graded according to the dimensions and number indicating the rate of recovery of the lesions. More than 90% (complete recovery), between 65% and 90% (moderate improvement), less than 65% (mild recovery). Mashhad University of Medical Sciences Approved 2018-10-10 Ethics committee of Mashhad of Medical Science Quraishi Building، University Street، Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)