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IRCT20220629055314N1 IRCT 2022-07-20 Arak University of Medical Sciences The effect of curcumin on the treatment of human papillomavirus infection The effect of curcumin on the clearance of human papillomavirus infection and the diagnostic quality of cervical smear in patients with high-risk human papillomavirus 2022-07-23 anticipated 90 Complete https://irct.ir/trial/64474 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: Both patients and all patient-related researchers will be unaware of receiving cinacurcumin or routine treatment. All women who are to be included in the study are coded, and the encrypted computer file shows what each code means, only if the person's health is compromised. Block randomization method will be used to assign eligible people to two groups. The size of the blocks is 4 and 6. Randomization will be done individually. In the block method, due to the use of different combinations in each block, it is not possible to predict the randomization sequence, so the concealment process will also be followed. To guarantee the concealment process, the generated randomization sequence will be extracted as an Excel file and will remain with the epidemiologist's colleague, then to allocate the eligible people to two groups, the sick person will contact the epidemiologist and for the status of each person's placement in the groups, A decision will be made according to the randomization sequence. The online program available on the Sealed Envelope website will be used to generate the block randomization sequence, Blinding description: All patients and researchers (responsible for data collection, responsible for follow-up and evaluation of results) are unaware of the content of the received drug and the drug is coded. A placebo will be used for blinding. Both groups will receive routine treatments. In addition to routine treatment, one group will receive curcumin and one placebo group. The packages are completely similar and unique codes will be attached to each package. Therefore, patients, researchers and statistical analysts will be unaware of the allocation of people to two groups. The codes will also be kept with the epidemiologist colleague until the codes will be opened at the end of the study. 3 Cervical human papilloma virus infection. Intervention 1: Intervention group: Sinacurcumin 40 (each capsule contains 40 mg of nanomicelle curcumin) orally once a day for 6 months. Intervention 2: Control group: They will receive placebo for six months, which they will consume orally for six months. Yes - There is a plan to make this available What will be shared: The data related to the evaluation after taking the drug and the evaluation before the intervention will be accessible anonymously When: Data will be available one month after the article is published To whom: All medical researchers working in scientific and academic research centers Conditions: Documents will be made available to the applicant if needed for a detailed review or supplementary idea about the project. Where to obtain: Arak University of Medical Sciences Vice Chancellor for Research and Technology How to obtain: After a written request to the Vice Chancellor for Research of the University of Medical Sciences, if the university approves, the documents will be available to the applicant, which may take between one and two months. Comments:
public maryam mohsenikia
emam khomini blv, taleghani hospital
Arak Iran (Islamic Republic of) 3814115091 +98 912 254 2150 m.mohsenikia@gamil.com Arak University of Medical Sciences scientific maryam mohsenikia
emam khomeini Blv, TALEGHANI HOSPITAL
Arak Iran (Islamic Republic of) 3814115091 +98 912 254 2150 M.MOHSENIKIA@GMAIL.COM Arak University of Medical Sciences Iran (Islamic Republic of) Women with high-risk Pap smear and HPV results Age 30 to 65 years 30 years 65 years Female Known immune deficiency or autoimmune disease HIV positive patients Long-term use of corticosteroids or immunosuppressants smoking Pregnancy Infection with CIN2 or CIN3 in cervical biopsy Use of anticoagulants such as heparin, aspirin, clopidogrel, dipyridamole, warfarin and ticlopidine History of allergies to turmeric or other drugs, foods and dyes Gallbladder stones or bile duct obstruction and diseases related to gastric acidosis or active gastrointestinal ulcers Candida, trichomoniasis, and other infections of the cervix or vaginitis Treatment - Drugs Placebo Intervention group: Sinacurcumin 40 (each capsule contains 40 mg of nanomicelle curcumin) orally once a day for 6 months. Control group: They will receive placebo for six months, which they will consume orally for six months Clearance of human papillomavirus infection from the cervix. Timepoint: Before the intervention and 6 months later. Method of measurement: Detection and Typing of Human Papilloma Virus by PCR. Diagnostic quality of cervical smear. Timepoint: Before the intervention and 6 months later. Method of measurement: Pap smear sampling from the cervix. Arak University of Medical Sciences Approved 2022-05-22 Ethics Committee of Arak University of Medical Sciences emam khomini blv, taleghani hospital arak Markazi Iran (Islamic Republic of)