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

Last updated: February 6, 2024
Sponsor: Catalysis SL
Overall Status: Active - Recruiting

Phase

2

Condition

Cervical Intraepithelial Neoplasia

Neoplasms

Carcinoma

Treatment

Glizigen® + Ocoxin-Viusid®

Clinical Study ID

NCT03549273
OOS-GLZ-2018
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

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 byvideo 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 theinstitution (complete blood count, platelets and erythrosedimentation. In the case ofmale sex (vasectomy, use of condoms) while the treatment lasts.

Exclusion

Exclusion Criteria:

  1. Patients who have received surgical, ablative, radiant, immunomodulatory orchemotherapy 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 possibilityof collaboration.
  6. Patients with a history of severe allergic history.
  7. Patients who are participating in another research.

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: Glizigen® + Ocoxin-Viusid®
Phase: 2
Study Start date:
March 11, 2019
Estimated Completion Date:
January 15, 2025

Study 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.

Connect with a study center

  • Our Lady of Rule No. 52 &/Remedios and Quiroga, Luyano

    Havana, 10500
    Cuba

    Active - Recruiting

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