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

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

Recruiting
18 years and older
Female
Phase 2

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Overview

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.

Description

Main objective: To evaluate the effect of the combination of Glizigen® and Ocoxin®-Viusid® in the treatment of high-grade cervical intraepithelial lesions. Specific objectives: 1. To evaluate the overall response (colposcopic, histological and virological) in patients treated with the combination of the natural products Glizigen® and Ocoxin®-Viusid® in the treatment of high-grade cervical intraepithelial lesions. 2. Evaluate the colposcopic response in patients treated with the combination of natural products. 3. Evaluate the histological response in patients treated with the combination of natural products after conization. 4. Evaluate the virological response in patients treated with the combination of natural products. 5.Describe adverse events during treatment.

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.

Study details
    Carcinoma
    Neoplasia; Intraepithelial
    Cervix
    Glandular Neoplasms
    Epithelial Neoplasm
    Neoplasms

NCT03549273

Catalysis SL

17 February 2024

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