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

V

Vitae Health Innovation

Status

Completed

Conditions

HPV

Treatments

Dietary Supplement: 1000 mg Betaglucans (daily)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06987396
VITAE HEALTH INNOVATION S.L.

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

Female

Ages

30+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Treated group with 1000 mg oral Betaglucans (Immunovita)
Experimental group
Treatment:
Dietary Supplement: 1000 mg Betaglucans (daily)
Control group without treatment (active surveillance)
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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