Status:
UNKNOWN
Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
Brief Summary
Knee Osteoarthritis is one of the most frequent rheumatic disorders in the population and, in many cases, it causes disability due to pain, stiffness and deformation. The drugs available for treatment...
Detailed Description
In order to identify possible participants, the project will be promoted in the outpatient waiting rooms for family medicine and specialties of the General Hospital of Zone # 1 of the Mexican Institut...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 16 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04511195
Start Date
July 10 2020
End Date
June 16 2021
Last Update
August 13 2020
Active Locations (1)
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1
Hospital General Regional Number 1 de l IMSS en Cuernavaca, Mor.
Cuernavaca, Morelos, Mexico, 62200