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

Catalysis SL

Status and phase: Enrolling; Phase 2

Conditions: Neoplasms; Neoplasia; Intraepithelial, Cervix; Carcinoma; Glandular Neoplasms; Epithelial Neoplasm

Treatments: Dietary Supplement: Glizigen® + Ocoxin-Viusid®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03549273

OOS-GLZ-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Treatment

Experimental group

Description:

Glizigen® spray + Ocoxin-Visuid® oral solution

Treatment:

Dietary Supplement: Glizigen® + Ocoxin-Viusid®