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Efficacy of Ozone therapy in patients with Endometriosis

Efficacy of Ozone therapy on the signs and symptoms of Endometriosis: a controlled and randomized study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5bzyrnq
Enrollment
Unknown
Registered
2023-08-10
Start date
2021-06-17
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

Endometriosis

Interventions

Participants will be randomly allocated into 4 groups via a computer system maintaining confidentiality with opaque, sealed and numbered envelopes. 1) Placebo control group (COzP): volunteers will rec

Sponsors

Universidade Brasil
Lead Sponsor
Universidade Brasil
Collaborator

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria adopted will be: Women with Endometriosis with laboratory diagnosis obtained through at least one of the following exams: specialized ultrasound with bowel preparation, pelvic magnetic resonance, videolaparoscopy and biopsy; age group between 20 and 50 years; absence of climacteric or premature ovarian failure; pelvic pain complaints; ability to respond to questionnaires; consent to participate in the study to sign the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria will be: history of hysterectomy or oophorectomy; pregnant or breastfeeding women; BMI greater than 30 kg/m2 have a history of previous physical abdominal trauma in the last 3 months; use of psychotropic medications; infectious-contagious diseases (tuberculosis, leprosy, HIV, systemic fungal diseases) or any other similar condition; severe underlying disease (heart, kidney, liver, lung) or malignancy; diabetes mellitus and decompensated hyperthyroidism; history of topical and aesthetic treatments in the last 3 months; glucose 6-phosphate deficiency; lack of ability or willingness to provide informed consent; lack of availability for visits or to comply with study procedures; hypersensitivity to ozone therapy treatment.

Design outcomes

Primary

MeasureTime frame
Evaluate pain during the 10 weeks of treatment and for 60 days after the applications, verified by the Visual Analog Scale questionnaire. This outcome is expected to assess whether there has been a reduction in pain based on the verification of a variation of at least 2 points in pre- and post-intervention measurements

Secondary

MeasureTime frame
Evaluate sexual function and quality of life during the 10 weeks of treatment and for 60 days after the applications, verified by the Endometriosis Health Profile Questionnaire (EHP-30). It is expected to evaluate the improvement or not of the patient's sexual function and quality of life from the verification of a variation of at least 2 points of pre- and post-intervention measurements.;Evaluate the anxiety and the level of depression during the 10 weeks of treatment and for 60 days after the applications, verified by the Beck Hopelessness Scale and the questionnaire dealing with", "overcoming", "coping", "taking care of", “endure” (short COPE). It is expected to evaluate the level of anxiety and the level of depression from the verification of a variation of at least 2 points of pre- and post-intervention measurements.

Countries

Brazil

Contacts

Public ContactJynani Morais

Universidade Brasil

jynanimg@hotmail.com+55(11)980210816

Outcome results

None listed

Source: REBEC (via WHO ICTRP)