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Effectiveness of Blue Led to treat Vaginal Candidiasis: randomized controlled trial

Effect of blue led in the treatment of Recurring Vaginal Candidíasis: randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-3zzqsfh
Enrollment
Unknown
Registered
2024-06-24
Start date
2024-06-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus Vulvae

Interventions

This is a randomized, double-blind, quantitative clinical study. The sample for this study will be simple random probabilistic, using a statistical program to calculate the same GPOWER® with effect si
Group II: Blue Light Emitting Diode-LED in sham form with methylene blue dye
Group III: Blue Light Emitting Diode-LED in active form plus methylene blue dye and oral antifungal metronidazole 250mg. all with 17 participants each
E02.774

Sponsors

Universidade Federal do Delta do Parnaíba UFDPAR
Lead Sponsor
Universidade Federal do Delta do Parnaíba UFDPAR
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: The research will include women; aged between 18 e 40 years; residing in the Coastal Plain; with a proven medical diagnosis of recurrent vaginal candidiasis; who have steady partners; are not pregnant or in menopause; are not immunocompromised patients or undergoing oncological treatment; are not undergoing use of metronidazole or other medication that may interfere with the vaginal microflora; do not present lesions in the Pap smear; and have good cognitive and verbal conditions, and who agree to participate in the research, after reading, understanding and signing the Free and Consent Form Clarified - TCLE

Exclusion criteria

Exclusion criteria: Volunteers will be excluded from the research if they have infections of other types; are treated for candidiasis with other modalities at the time of the research; if their partners do not undergo the associated treatment; if they request to withdraw from the research

Design outcomes

Secondary

MeasureTime frame
Improvement in quality of life, quality of sleep, level of stress, anxiety, depression in volunteers with adequate adherence to treatment

Primary

MeasureTime frame
Elimination or reduction of Candida albicans infection through photobiomodulation with blue Light Emitting Diode-LED in the treatment of recurrent vaginal candidiasis in menaccal women

Countries

Brazil

Contacts

Public ContactGuilherme Gouveia

Universidade Federal do Delta do Parnaíba

gpfatufpi@gmail.com55 (86) 999939674

Outcome results

None listed

Source: REBEC (via WHO ICTRP)