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Study of the therapeutic effect of an added gel with Pequi Oil on the functionality of patients with knee osteoarthritis.

Study of the therapeutic effect of nanoestrutured pharmaceutical preparation incorporated with Pequi Oil (Caryocar Coriaceum) in the functionality of patients with Gonartrosis.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-33ybrc
Enrollment
Unknown
Registered
2018-04-29
Start date
2018-01-02
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

Gonarthrosis.

Interventions

A pilot study was conducted with 15 patients to analyze the toxicity of the Carbopol hydrogel containing pequi oil. Where it was applied in a circle marked on the forearm 4g containing only carbopol h
Biological/vaccine
H01.158.703.152
E01.370.600.550.324
E05.318.308.980

Sponsors

Fundação Universidade Federal do Sergipe
Lead Sponsor
Universidade Tiradentes
Collaborator

Eligibility

Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Be over 50 years old; Radiography showing grade 2 to 4 gonarthrosis according to the Kellgren-Lawrence scale (KELLGREN, et al., 1957); Pain in the knee; Complete at least one of the American College of Rheumatology (ALTMAN, et al., 1986) classification criteria. According to Kellgren-Lawrence (1957), changes in X-rays caused by osteoarthrosis are classified as: normal (grade 0); possible narrowing of joint space and defined osteophyte (Grade II); defined narrowing of the joint space, multiple moderate osteophytes, some subchondral sclerosis and possible deformity of the bone contour (Grade III); articular space narrowing, severe subchondral sclerosis, defined deformity of the bone contour and presence of large osteophytes (Grade IV). The classification criteria of the American College of Rheumatology are (ALTMAN, et al., 1986): Clinical and physical evaluation (knee pain and three of the following: over 50 years of age, less than 30 minutes of morning joint stiffness, bone fragility, joint heat). Clinical, physical and radiographic evaluation (knee pain and one of the following: over 50 years of age, less than 30 minutes of morning joint stiffness, crackling of the active movement and presence of osteophytes). Clinical, physical, and laboratory evaluation (knee pain and five of the following: over 50 years of age, less than 30 minutes of morning joint stiffness, bone fragility, bone enlargement, joint heat, crackling to active movement.

Exclusion criteria

Exclusion criteria: Presence of autoimmune diseases; Open wounds or skin lesions in the knee region; Chronic diffuse pain (fibromyalgia); Cancer.

Design outcomes

Primary

MeasureTime frame
Reduction of the inflammatory level of cytokines through the collection of blood that will be performed at the beginning of the study and at the end of the study.;SF-36 quality of life questionnaires to quantify how much the patient evolved during treatment. Will be applied weekly for 3 weeks.;Evolution in values related to knee symptoms using the Lysholm questionnaire that will be applied weekly for 3 weeks.;Improvement in pain tolerance with pressure algometer being applied weekly for 3 weeks.;Improvement in gait quality and increase of speed to roam in the Time Up and Go test being evaluated weekly for 3 weeks.;Evolution in muscle strength due to reduction of pain, we will use the dynamometer to measure the evolution being evaluated weekly for 3 weeks.;Development in the range of motion, using the fleximeter for measurement, and weekly collection for 3 weeks.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactLucindo Quintans Júnior

Fundação Universidade Federal de Sergipe

lucindojr@gmail.com+55-079-988015026

Outcome results

None listed

Source: REBEC (via WHO ICTRP)