Status:
COMPLETED
Clinical Investigation to Assess the Effect of Betaglucan Administration in HPV Patients
Lead Sponsor:
Vitae Health Innovation
Conditions:
HPV
Eligibility:
FEMALE
30+ years
Phase:
NA
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). ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06987396
Start Date
May 15 2023
End Date
May 15 2025
Last Update
May 23 2025
Active Locations (1)
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1
Gynaecology Department, Medical Service Ishtar
Barcelona, Spain, 08034