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IRCT20200509047350N1 IRCT 2020-05-14 Khoram-Abad University of Medical Sciences The effect of olive leaf extract and curcumin combination on improvement of clinical signs and symptoms and quality of life in patients with external anogenital wart The effect of olive leaf extract and curcumin combination on improvement of clinical signs and symptoms and quality of life in patients with external anogenital wart 2020-06-21 anticipated 66 Complete https://irct.ir/trial/47991 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Routine treatment in both groups means that on the first day of treatment, the midwife will first cover the wart with Vaseline cream containing vitamin E and then place a full swab soaked in pedophyllin 20% on the wart. The solution should be on the lesion for 4 hours and not washed under any circumstances. Before applying the ointment, a thin layer of the drug is placed on the inside of the forearm for 20 minutes and the redness, itching, burning, swelling and skin lesions will be examined. The lesion will be washed with water. Then the site of the lesion is dried and patients, according to the control groups and olive-curcumin leaf extract, apply 10% ointment to the lesions with a swab, and do not wash it until the next dose. This is done from the first day of treatment after pedophilia (once a week) for 3 times a day until complete recovery (maximum 12 weeks). The exact time and date of the start of treatment will be recorded by the researcher and the patient will be given the necessary training to take the medication. To receive pedophylline, the patient sees a specialist once a week, and the disease is examined and, if necessary, continued treatment. How to blind the study is done in such a way that the patient and the researcher and statistical analyst do not know how to divide people into groups. Each person will receive their own code and will be grouped into 1.2 groups using coding. Then, with the help of an obstetrician's examination, the treatment process is checked by observing privacy and the principle of confidentiality. The patient informs the researcher of the time of recovery of the lesions after the start of treatment as the exact time and date. The number of lesions before consumption, daily (at intervals of weekly visits by the patient), is examined and recorded every week by a midwife by direct observation according to the time of complete recovery after taking the medication. The quality of life questionnaire will be completed by the researcher before starting treatment and after complete recovery. The researcher will follow the patient from the first day of treatment until the next visit (once a week) using a mobile phone and contacting the patient (self-report), in terms of side effects (pain, bleeding, scaling, itching). It should be noted that the follow-up of drug use and washing by the subjects will be done by telephone by the researcher. Patients who may have a full recovery earlier than the due date should report the exact date and time of the recovery to the researcher during these calls, Randomization description: Random block block The volume of each block is 4, so that 6 different combinations of 4 blocks are created and are selected randomly by placing the blocks, Blinding description: In this study, the Research Center codes the drug and placebo with specific and confidential codes. While using the patient, the researcher, the analyst, is not aware of the research groups (whether the patient has received the medication or the placebo) and is only in the groups with the medication codes they received. Finally, after analyzing the data, decryption is performed by the research center. 3 Genital Warts. Intervention 1: Intervention group:Routine treatment with pedophile 20% once a week until clinical repair (maximum 12 weeks) and the use of 10% olive leaf extract ointment and 10% curcumin in the amount of 2 mm) (9 made by the University Health and Nutrition Research Center) Khorramabad Medical Sciences) 3 times a day until recovery (maximum 12 weeks). On the first day of treatment, the midwife will first cover the wart with a vitamin E-containing Vaseline cream and then place a full 20% pedophile -soaked swab on the wart. The solution should be on the lesion for 4 hours and not washed under any circumstances. Before applying the ointment, a thin layer of the drug is placed on the inside of the forearm for 20 minutes and the redness, itching, burning, swelling and skin lesions will be examined. The lesion will be washed with water. Then the site of the lesion is dried and the patients extract 10% of the ointment from the olive-curcumin leaf extract with a swab, and do not wash it until the next dose. Intervention 2: Control group: Routine treatment with pedophyllin 20% once a week until clinical repair (maximum 12 weeks) and the use of placebo (size 2 mm) (manufactured by Khorramabad University of Medical Sciences) 3 times a day until Recovery (maximum 12 weeks). On the first day of treatment, the midwife will first cover the wart with a vitamin E-containing Vaseline cream and then place a full 20% pedophyllin -soaked swab on the wart. The solution should be on the lesion for 4 hours and not washed under any circumstances. Before applying the ointment, a thin layer of placebo is placed on the inside of the forearm for 20 minutes to examine for redness, itching, burning, swelling, and skin lesions. The lesion will be washed with water. Then the site of the lesion is dried and the patients are given a placebo with a swab to the lesion, to avoid washing it until the next dose. Yes - There is a plan to make this available What will be shared: Information on the effect of the drug on primary and secondary outcomes. When: Start the access period 6 months after printing the results To whom: researchers Conditions: Researchers first obtain permission from the researcher and refer to their research objectives to use any data or information. Where to obtain: Postal address: Khorramabad, Lorestan University of Medical Sciences, Faculty of Nursing and Midwifery - Fatemeh Mehrabi Rad Contact Number: 00986633120140 Email: fatememehrabirad@gmail.com How to obtain: Dear researchers, you can ask your questions via email address Email: fatememehrabirad@gmail.com. We will answer your questions as soon as possible. Comments:
public Tahereh Toulabi
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem Street
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3330 0661 toulabi_t@yahoo.com Khoram-Abad University of Medical Sciences scientific Tahereh Toulabi
University of Medical Sciences , Shahid Anoushirvan Rezaei Square , Moallem Street
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3330 0661 toulabi_t@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Confirmation and introduction of a midwifery specialist for the patient to enter the study (having external anogenital warts) Age 18 and up No pregnancy or lactation The desire to participate in research and sign a conscious consent Lack of incurable, metabolic and chronic diseases and weakness in the immune system Do not use corticosteroids or antiviral drugs and weaken the immune system during research Lack of pelvic inflammatory disease, other genital infectious diseases Failure to participate in other research that in any way affects the results of the research Phone access 18 years no limit Female Lack of proper and appropriate use of drugs Lack of desire to continue research Any allergies caused by the drug Disabling the patient or changing the patient's contact number and not answering the phone call Pregnancy Severe type of disease that requires surgery or systemic medication A63.0 Anogenital (venereal) warts Treatment - Drugs Placebo Intervention group:Routine treatment with pedophile 20% once a week until clinical repair (maximum 12 weeks) and the use of 10% olive leaf extract ointment and 10% curcumin in the amount of 2 mm) (9 made by the University Health and Nutrition Research Center) Khorramabad Medical Sciences) 3 times a day until recovery (maximum 12 weeks). On the first day of treatment, the midwife will first cover the wart with a vitamin E-containing Vaseline cream and then place a full 20% pedophile -soaked swab on the wart. The solution should be on the lesion for 4 hours and not washed under any circumstances. Before applying the ointment, a thin layer of the drug is placed on the inside of the forearm for 20 minutes and the redness, itching, burning, swelling and skin lesions will be examined. The lesion will be washed with water. Then the site of the lesion is dried and the patients extract 10% of the ointment from the olive-curcumin leaf extract with a swab, and do not wash it until the next dose. Control group: Routine treatment with pedophyllin 20% once a week until clinical repair (maximum 12 weeks) and the use of placebo (size 2 mm) (manufactured by Khorramabad University of Medical Sciences) 3 times a day until Recovery (maximum 12 weeks). On the first day of treatment, the midwife will first cover the wart with a vitamin E-containing Vaseline cream and then place a full 20% pedophyllin -soaked swab on the wart. The solution should be on the lesion for 4 hours and not washed under any circumstances. Before applying the ointment, a thin layer of placebo is placed on the inside of the forearm for 20 minutes to examine for redness, itching, burning, swelling, and skin lesions. The lesion will be washed with water. Then the site of the lesion is dried and the patients are given a placebo with a swab to the lesion, to avoid washing it until the next dose. Clinical Signs and Symptoms: In this study, the clinical signs and symptoms of itching, burning, pain, warts and bleeding are considered. Timepoint: Every week and the intervals between visits for a maximum of 12 weeks. Method of measurement: clinical examination, self-report. Quality of Life. Timepoint: The day before treatment, after clinical repair. Method of measurement: Life Quality Questionnaire 36 questions SF36. Khoram-Abad University of Medical Sciences Approved 2020-05-06 Ethics committee of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem St. Khorramabad Lorestan Iran (Islamic Republic of)