Evaluation Glizigen® and Ocoxin®-Viusid® in High-grade Cervical Intraepithelial Lesions

Summary

Phase II clinical trial, monocentric, not controlled, in patients with high grade cervical intraepithelial lesions. A total of 62 patients with a diagnosis of CIN II, III or carcinoma in situ will be included. It is expected that with the combination of natural products Glizigen® and Ocoxin®-Viusid® at least 60% of patients with treated intraepithelial lesions (IEL) have a global response (complete or partial), with elimination of the human papillomavirus and the viral load.

Eligibility

Inclusion Criteria:

1. Patients that meet the diagnostic criteria.
2. Patients with age ≥18 years.
3. Patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (Criteria from Rio 2011).
4. Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58).
5. Patients who give their informed consent to participation in writing.
6. Patients who consent to perform the conization according to the study schedule.
7. Patients with normal laboratory parameters within the limits established in the institution (complete blood count, platelets and erythrosedimentation. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.

Exclusion Criteria:

1. Patients who have received surgical, ablative, radiant, immunomodulatory or chemotherapy treatment 30 days before recruitment.
2. Patients pregnant or breastfeeding.
3. Patients with acute cervico-vaginal infections.
4. Patients with positive serology known to HIV and/or syphilis.
5. Patients with diseases that compromise the state of consciousness or their possibility of collaboration.
6. Patients with a history of severe allergic history.
7. Patients who are participating in another research.

Conditions6

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