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

Determining the effect of curcumin on the clearance of human papillomavirus infection and the diagnostic quality of cervical smear

Clinical trial with control group, double-blind, randomized, phase 3 on 90 patients. Excel software rand function was used for randomization.

Women between the ages of 30 and 65 who have been referred for Pap smear screening and then have been asked for HPV typing and reported a "high risk" outcome will be invited to enter the study based on inclusion and exclusion criteria. Admission of patients to the study will be available and easy, but their allocation in two groups of intervention or placebo will be done by simple random assignment with the help of a computer. In the intervention group, patients treated with cinacurcumin 40 are given orally once daily for 6 months. In the control group, patients will be treated routinely. Groups will be given dietary recommendations. Location: Taleghani Hospital, Arak University of Medical Sciences

Inclusion criteria: Women with high-risk Pap smear and HPV results; Age 30 to 65 years, no candidiasis or candidiasis vaginitis, trichomoniasis, and other infections; no known immunodeficiency or autoimmune disease; HIV-positive patients; no long-term use of corticosteroids or immunosuppressants; no smoking; no pregnancy; no CIN2 or CIN3 in cervical biopsy. Exclusion criteria: Patient dissatisfaction with participation in the project.

In the intervention group of cinacurcumin 40 one oral drug of Sina drug will be prescribed daily for 6 months. Control group, placebo (capsules similar to the main drug to be purchased from the company, Will receive routine treatment.

The main measurable outcome is HPV and Pap smears, and other outcomes include lesion size, patients' clinical signs, and drug side effects.

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.

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.

The data related to the evaluation after taking the drug and the evaluation before the intervention will be accessible anonymously

Data will be available one month after the article is published

All medical researchers working in scientific and academic research centers

Documents will be made available to the applicant if needed for a detailed review or supplementary idea about the project.

Arak University of Medical Sciences Vice Chancellor for Research and Technology

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.