Evaluation of the Effect of the Combination of the Natural Products Glizigen® and Ocoxin®-Viusid® in the Treatment of High-grade Cervical Intraepithelial Lesions. Phase II
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Catalysis SL
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Lesion progression
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Lesion progression
Time Frame: 9 months
Colonoscopy. The categories will analyze as: * Complete Response-CR (Disappearance of the initial lesion and no new lesions appear). * Partial Response-PR (Reduction between 30 to 50% or more of the initial lesion and no new lesions appear). * Stable disease-SD (Same morphometry or reduction of less than 30% of the initial lesion). * Progressive Disease-PD (Increase in the diameter of the lesion The lesion extends to one or more quadrants that were not in the initial lesion. It will be considered progressive disease when at least two of the response variables are present.The variable viral load will always be present).
Secondary Outcomes
- Colposcopy response(9 months)
- Histological Response(9 months)
- Virological response(9 months)
- Adverse Events (AE)(9 months)