Clinical trial · Interventional
Evaluation Glizigen® and Ocoxin®-Viusid® in High-grade Cervical Intraepithelial Lesions
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
NCT03549273CI-TRIAL-00073731unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Epithelial Neoplasm | Epithelial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Glandular Neoplasms | — | UNRESOLVED | — |
| Neoplasia; Intraepithelial, Cervix | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glizigen® + Ocoxin-Viusid® | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Glizigen® spray + Ocoxin-Visuid® oral solution
- interventionNames
- Dietary Supplement: Glizigen® + Ocoxin-Viusid®
Primary outcomes (3)
- measure
- Lesion progression
- timeFrame
- 9 months
- description
- 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).
- measure
- Lesion progression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDde Villiers EM. Cross-roads in the classification of papillomaviruses. Virology. 2013 Oct;445(1-2):2-10. doi: 10.1016/j.virol.2013.04.023. Epub 2013 May 16. PMID 23683837
- BACKGROUNDA'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721. PMID 11252008
- BACKGROUNDBornstein J, Bentley J, Bosze P, Girardi F, Haefner H, Menton M, Perrotta M, Prendiville W, Russell P, Sideri M, Strander B, Tatti S, Torne A, Walker P. 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet Gynecol. 2012 Jul;120(1):166-72. doi: 10.1097/AOG.0b013e318254f90c. PMID 22914406
- BACKGROUNDHernandez-Garcia S, Gonzalez V, Sanz E, Pandiella A. Effect of Oncoxin Oral Solution in HER2-Overexpressing Breast Cancer. Nutr Cancer. 2015;67(7):1159-69. doi: 10.1080/01635581.2015.1068819. Epub 2015 Aug 4. PMID 26241555
- BACKGROUNDDiaz-Rodriguez E, Hernandez-Garcia S, Sanz E, Pandiella A. Antitumoral effect of Ocoxin on acute myeloid leukemia. Oncotarget. 2016 Feb 2;7(5):6231-42. doi: 10.18632/oncotarget.6862. PMID 26756220
- BACKGROUNDVilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x. PMID 17311621
- BACKGROUNDStillo M, Carrillo Santisteve P, Lopalco PL. Safety of human papillomavirus vaccines: a review. Expert Opin Drug Saf. 2015 May;14(5):697-712. doi: 10.1517/14740338.2015.1013532. Epub 2015 Feb 18. PMID 25689872