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Clinical Trials/NCT06987396
NCT06987396CompletedNot Applicable

Clinical Investigation to Assess the Effect of Betaglucan Administration in HPV Patients

Vitae Health Innovation2 sites in 1 country80 target enrollmentStarted: May 15, 2023Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
2
Primary Endpoint
RNA PCR Test result
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Randomised, controlled clinical study to assess the efficacy and tolerability of an oral supplementation of 1000 mg daily of Betaglucans in the evolution of patients with Human Papilloma Virus (HPV). The improvement is measured by DNA PCR test, cytology and a specific RNA test.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

RNA and DNA PCR tests were performed by a blinded external laboratory

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Women over 30 years old, whether or not they have been vaccinated against HPV
  • •Patients attending a visit with a routine cytological result of ASCUS or lSIL, or a normal result with a positive HPV test, no more than 3 months prior to be enrolled
  • •Patients who freely provide written informed consent
  • •Patients with a positive DNA PCR test

Exclusion Criteria

  • •Patients who are participating in another clinical study about the same or different condition within the 30 days prior to inclusion.
  • •Any subject who, in the investigator's opinion, is unable to follow instructions or properly comply with the treatment.
  • •Subjects who do not provide written informed consent to participate in the study.
  • •Patients who are receiving any of the prohibited drugs or supplements, and for whom withdrawal of these medications/products is expected to pose a significant issue.
  • •Pregnant or breastfeeding women.
  • •Transplanted patients and/or patients taking immunosuppressive medication.
  • •Patients with autoimmune diseases.

Outcomes

Primary Outcomes

RNA PCR Test result

Time Frame: From enrollment to the end of treatment at 6 months

Secondary Outcomes

  • DNA PCR Test result(From enrollment to the end of treatment at 6 months)
  • Citology Test result(From enrollment to the end of treatment at 6 months)

Investigators

Sponsor
Vitae Health Innovation
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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