Knee Osteoarthritis Clinical Trial
Official title:
Effectiveness and Safety of a Phytopharmaceutical Produced With an Extract of Sphaeralcea Angustifolia as a Topical Treatment of Knee Osteoarthritis: A Randomized Double Blind Clinical Trial
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 cause adverse events that are sometimes very severe and, for this reason, the
development of new drugs for topical administration with fewer adverse events is desirable.
OBJECTIVE:
To elaborate a phytopharmaceuticals for topical administration with a standardized extract of
Sphaeralcea angustifolia and evaluate its efficacy and therapeutic tolerability when
administered in patients diagnosed with knee osteoarthritis.
MATERIAL AND METHODS:
An extract will be obtained from the aerial parts of the plant species S. angustifolia with
which a phytomedicine will be designed in a pharmaceutical presentation for topical
administration. Once the phytomedicine has been designed, it will be scaled at the pilot
plant level and the drug produced will be subjected to a clinical study in order to evaluate
its efficacy and therapeutic tolerability in patients diagnosed with knee osteoarthritis.
Through a double-blind, randomized, controlled clinical study with 2% diclofenac, patients
will be treated topically for four weeks. The evolution of the disease will be evaluated
weekly during the four weeks of treatment through the Visual Analogue Scale (VAS) Western
Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of function. The primary
outcome variable will be: therapeutic efficacy (clinical parameters for the evolution of knee
pain). The secondary outcome variables will be therapeutic tolerability (side effects that
are triggered by the application of the drug), and the Western Ontario and McMaster
Universities Osteoarthritis Index (WOMAC) of function. A scale used to evaluate function of
the knee
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 Institute of Social Security (IMSS) in Cuernavaca, Morelos.
People interested in participating will be asked to go to the clinical research office so
that the supporting physician will perform a medical history in addition to a physical
examination, in this way the clinical diagnosis of knee osteoarthritis will be made and it
will be defined if the patient meets the clinical criteria necessary to be included in the
study. Once it is determined that the patient is a possible candidate and the diagnostic,
treatment and follow-up procedures can be continued, the patient will need to sign an
informed consent letter, duly completed and authorized by the Ethics Committee. Otherwise, if
patient decide not to participate, an interconsultation with the corresponding family doctor
will be given.
To make the radiological diagnosis, the patient will be submitted to X-ray office, in order
to take a front to back and lateral knee (s) radiograph. Once the diagnosis is corroborated,
the participants will prepare a file that will contain a questionnaire with questions related
to sociodemographic, personal, family and condition history, in addition, treatment will be
assigned with the corresponding folio number upon admission. Each of the patients will be
given oral and written instructions on how the treatment should be administered and the
hygienic measures that must be followed during their participation in the study. The first
administration of the treatment will be in the research office, in order to teach the
participant how to do it; later, instructions about how the medication should be administered
three times a day in the affected knee (s), for four weeks will be given.
Patients will be cited every week for four weeks where their evolution will be assessed; in
each of the appointments. Patients will undergo a complete evaluation of their condition,
there will be a format in which each of the data that is collected will be recorded, either
at the interrogation or on the physical examination.
The patients will be summoned every week in order to evaluate the evolution of the disease,
and consequently the therapeutic efficacy by means of the Visual Analogue Scale of pain and
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of function, a
scale used to evaluate function of the knee. The presence of adverse effects (Therapeutic
tolerability) and the adherence to the treatment (based on the days of administration) will
be evaluated. A concentrate related to tolerability and adherence to treatment will be filled
in each of the patients.
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