HPV
Conditions
Keywords
HPV, Betaglucans, Immunity, RNA
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.
Interventions
DIETARY_SUPPLEMENT1000 mg Betaglucans (daily)
Patients in the experimental group receive betaglucans supplement in capsule form, administered orally
Sponsors
Vitae Health Innovation
Study design
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
Sex/Gender
FEMALE
Age
30 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RNA PCR Test result | From enrollment to the end of treatment at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Outcome results
None listed