Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis
Status:
Recruiting
Trial end date:
2021-06-16
Target enrollment:
Participant gender:
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 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