The effective dose of nutrition bio-shield (NBS) superfood in the treatment of women with human papilloma virus (HPV)

The results of this study can help in finding an adjuvant treatment without complications, as well as its effective dose on HPV lesions in infected individuals.

A controlled, parallel-group, single-blind, randomized clinical trial on 48 patients.

In this study, 48 women referring to the gynecological clinic of Fatemieh Hospital, Hamadan, with genital lesions, who were confirmed to have HPV by a Pap smear, were randomly enrolled in the study. The patients were then divided into three groups of 12 based on the genotyping results and given placebo or different doses of NBS in each group. The patients were treated and followed up for a period of 6 months and the improvement of HPV lesions was assessed. At the beginning, in the third month and at the end of treatment, the patients' biopsy and serum samples were examined and compared for specific papilloma and inflammatory factors tests as well as general organ health tests, which included the following: HPV genotyping, INF- ƴ, IgG1, SGOT, SGPT, ALP, Bili T & D, BUN, CR, FBS, TG, Chol, HDL, LDL, CBC, ESR

Women with genital lesions who have been confirmed to have HPV by a Pap smear will be included in the study. To ensure that NBS does not affect other organs of the body, patients with a history of taking any specific medications or specific diseases will be excluded from the study.

Group A or control in which subjects will receive placebo Group B in which subjects will receive 2.5 grams of NBS daily Group C in which subjects will receive 5 grams of NBS daily Group D in which subjects will receive 10 grams of NBS daily

The results of this study can help in finding an adjuvant treatment without complications, as well as its effective dose on HPV lesions in infected individuals.

This study uses stratified randomization, in which a total of 48 women with HPV will be enrolled based on initial genotyping, of which 16 will have Low risk HPV, 16 will have High risk HPV, and 16 will have Low risk + High risk HPV, each of which will have its own separate basket. Then, each group will be randomly divided into 4 groups of 4: A. 4 patients will receive placebo only. B. 4 patients will receive 2.5 grams of NBS daily. C. 4 patients will receive 5 grams of NBS daily. D. 4 patients will receive 10 grams of NBS daily. Therefore, each basket contains 16 envelopes and patients will choose randomly. Each envelope has a code written in it (code A, B, C, and D as explained above) and patients are asked to report the code written inside the envelope to the doctor. Then, based on the reported code, the amount of drug or placebo is prescribed to the patient and the required educations and the next visit are determined.

The present study will be single-blinded in that, after explaining the study process and obtaining informed consent, the appropriate dose of NBS or placebo will be prescribed by the caregiver based on the code written inside the envelope. The patient will not be informed of the difference in the dose from other participants or receiving placebo, and only the health care provider or physician and the researcher will be aware of the code description.