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Clinical Trials/RPCEC00000271
RPCEC00000271
Not yet recruiting
Phase 2

Evaluation of the effect of the combination of the natural products Glizigen® and Oncoxin®-Viusid® in the treatment of high-grade cervical intraepithelial lesions . Phase II

aboratorios Catalysis S.L.0 sites62 target enrollmentMay 9, 2018
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ConditionsCervical intraepithelial lesionsCervical Intraepithelial NeoplasiaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cervical intraepithelial lesions
Sponsor
aboratorios Catalysis S.L.
Enrollment
62
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 9, 2018
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Sponsor
aboratorios Catalysis S.L.

Eligibility 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

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.

Outcomes

Primary Outcomes

Not specified

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