Assessment the Efficacy of Lactoferin as a Natural Product in Virus Clearance in HPV+ Patients: Randomized Double Blind Clinical trial

Evaluation of the effectiveness of vaginal lactoferrin tablets after the end of 6 months in terms of removing the virus (HPV + or HPV -) compared to placebo.

First, the descriptive analysis of the variables in the study will be done. To ensure the correctness of the random assignment, all the variables collected before the start of vaccination (baseline) will be compared in the 2 groups.

• Initial visit (zero time): review of complete blood test results and completion of patient demographic questionnaire - physical examination - review of HPV test results (positive/negative - genotyping) - pap smear (cytology, biopsy/pathology) • Second visit (3 months after the start of the study): physical examination - checking the response of the HPV test (positive/negative - genotyping) - pap smear (cytology, biopsy/pathology) • Third visit (6 months after the start of the study): physical examination - checking the response of the HPV test (positive/negative - genotyping) - pap smear (cytology, biopsy/pathology) Yas Hospital - Dr. Keyvan Medical Virology Specialist Laboratory

During the treatment period, people were encouraged to use the drug according to the brochure and daily. At the end of the treatment, the patients were evaluated for virus clearance with HPV test and pap smear for six months at 3 and 6 month visits.

Female patients with a certain age group, whose HPV test is positive for high-risk strains such as 16, 18 and have a normal pap smear and are classified as CIN1 in terms of citerlogy, can enter the study, but those who are pregnant, have a history of alcohol and smoking, and have a history of warts The use of immunosuppressant drugs is subject to

HPV virus, Virus genotype, Cytology of secretions (Pap smear)

Randomization will be done in blocks of 8 blocks. Excel software and the rand() function are used to prepare random sequences inside each block. After determining the type of intervention in each participant, a non-repeating four-digit code is assigned to the individual. This number is the participant's randomization code and will be identified with this number until the end of the study. This number will be written on all the pages of the participant information collection forms. People will enter the study in blocks of 8, each block will have a variable number of 3 treatment and placebo groups. In total and at the end, four groups of 20 people will receive placebo and three different concentrations of the drug respectively.

The study is double-blind, and only the principal investigator and the epidemiologist know about the assigned treatment, and the physician, evaluator, and laboratory will all be masked. (Regarding the similarity of the packaging of pharmaceutical forms and placebo - the sameness of all tests, sampling, questionnaires and other conditions of the study).

research section at PII site ( Pasteur.ac.ir)

unlimited

researchers and patients attending the study

detailed information about study

contact with responsible person

phone contact

for more information email would be also applicable