Evaluating Glizigen® and Ocoxin®-Viusid® for treating high-grade cervical 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
This study is testing if a combination of natural products, Glizigen® and Ocoxin®-Viusid®, can help people with high-grade cervical lesions improve their condition and reduce the presence of HPV.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Catalysis SL Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Havana) |
| Trial ID | NCT03549273 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial aims to assess the effectiveness of the combination of natural products Glizigen® and Ocoxin®-Viusid® in patients diagnosed with high-grade cervical intraepithelial lesions (CIN II, III, or carcinoma in situ). The study will include 62 participants and will evaluate overall, colposcopic, histological, and virological responses to the treatment. The goal is to achieve a global response in at least 60% of patients, including the elimination of human papillomavirus and reduction of viral load. Adverse events during treatment will also be documented.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a diagnosis of high-grade cervical intraepithelial lesions and a positive test for oncogenic human papillomavirus.
Not a fit: Patients who have undergone recent surgical, ablative, or chemotherapy treatments, as well as those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients with high-grade cervical lesions, potentially reducing the need for surgical interventions.
How similar studies have performed: While the use of natural products in treating cervical lesions is an emerging area, this specific combination has not been extensively tested in prior studies, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Havana
- Our Lady of Rule No. 52 &/Remedios and Quiroga, Luyano — Havana, Cuba (Recruiting)
Study contacts
- Study coordinator: Águeda Santana Martínez
- Email: aguesam@infomed.sld.cu
- Phone: 7 690-7225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.