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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2023
  • participants needed
    62
  • sponsor
    Catalysis SL
Updated on 4 October 2022
vasectomy
carcinoma
human papillomavirus
blood cell count
colposcopy
ocoxin
ocoxin-viusid
cervical intraepithelial neoplasia grade 2
cone biopsy

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.

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.

Details
Condition Carcinoma, Neoplasia; Intraepithelial, Cervix, Glandular Neoplasms, Epithelial Neoplasm, Neoplasms
Treatment Glizigen® + Ocoxin-Viusid®
Clinical Study IdentifierNCT03549273
SponsorCatalysis SL
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients that meet the diagnostic criteria
Patients with age ≥18 years
Patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (Criteria from Rio 2011)
Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58)
Patients who give their informed consent to participation in writing
Patients who consent to perform the conization according to the study schedule
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

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