Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04511195
Eligibility Criteria:
Inclusion Criteria:
* With clinical diagnosis of knee osteoarthritis based on the criteria for the classification of knee osteoarthritis and radiological classification of Kellgren and Lawrence osteoarthritis in Grade I-III.
* 40-65 years old
* Affected knee (s) must present: a) pain intensity of at least 4 cm (on the numerical scale for pain, 0-10 cm), in the knee that presents the higher pain, in the 24 hours prior to admission, b) obtain a score of not less than 50 points, according to the modified index for the clinical state of the knee with osteoarthritis, c) agree to participate in the study and sign an informed consent letter
Exclusion Criteria:
* Patients with a history of having received oral or parenteral corticosteroids for three months prior to enrollment,
* who have received anti-inflammatory drugs for 10 days before starting the study,
* who have received pain relievers for at least 3 days before the start of treatment.
* who are in some type of treatment for osteoarthritis including intra-articular infiltration.
* Patients with a Body Mass Index ≥ 30, immunosuppressed, with no controlled diabetes mellitus or hypertension
* pregnant women
* patients with high risk for not adequately managing their treatment, such as drug addicts, alcoholics
* Patients with secondary osteoarthritis (causes other than joint degeneration), with trauma to the knees in the last two months, with residual pain after trauma or post-surgery, with pain and stiffness due to tissues in the healing phase
* patients with a known intolerance to diclofenac or plant species.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT04511195
Study Brief:
Protocol Section:
NCT04511195