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
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 16, 2021 |
Est. primary completion date | January 16, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital General Regional Number 1 de l IMSS en Cuernavaca, Mor. | Cuernavaca | Morelos |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico |
Mexico,
Meckes M, David-Rivera AD, Nava-Aguilar V, Jimenez A. Activity of some Mexican medicinal plant extracts on carrageenan-induced rat paw edema. Phytomedicine. 2004 Jul;11(5):446-51. — View Citation
Pérez-Hernández J, González-Cortazar M, Marquina S, Herrera-Ruiz M, Meckes-Fischer M, Tortoriello J, Cruz-Sosa F, Nicasio-Torres Mdel P. Sphaeralcic acid and tomentin, anti-inflammatory compounds produced in cell suspension cultures of Sphaeralcea angustifolia. Planta Med. 2014 Feb;80(2-3):209-14. doi: 10.1055/s-0033-1360302. Epub 2014 Jan 31. — View Citation
Pérez-Hernández J, Nicasio-Torres MDP, Sarmiento-López LG, Rodríguez-Monroy M. Production of anti-inflammatory compounds in Sphaeralcea angustifolia cell suspension cultivated in stirred tank bioreactor. Eng Life Sci. 2019 Jan 2;19(3):196-205. doi: 10.1002/elsc.201800134. eCollection 2019 Mar. — View Citation
Romero-Cerecero O, Meckes-Fischer M, Zamilpa A, Enrique Jiménez-Ferrer J, Nicasio-Torres P, Pérez-García D, Tortoriello J. Clinical trial for evaluating the effectiveness and tolerability of topical Sphaeralcea angustifolia treatment in hand osteoarthritis. J Ethnopharmacol. 2013 May 20;147(2):467-73. doi: 10.1016/j.jep.2013.03.040. Epub 2013 Mar 23. — View Citation
Serrano-Román J, Nicasio-Torres P, Hernández-Pérez E, Jiménez-Ferrer E. Elimination pharmacokinetics of sphaeralcic acid, tomentin and scopoletin mixture from a standardized fraction of Sphaeralcea angustifolia (Cav.) G. Don orally administered. J Pharm Biomed Anal. 2020 May 10;183:113143. doi: 10.1016/j.jpba.2020.113143. Epub 2020 Feb 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic efficacy: Improvement of the clinical condition higher than 80 %. It will be measured by means of Visual Analogue Scale of pain. | Therapeutic efficacy will be considered when the patient presents a reduction of pain higher than 80 % on the scales of measurement Visual Analogue Scale of pain. Visual Analogue Scale (VAS) is a scale used to identify the pain intensity experienced by a patient. It consist of a line, 10 cm in length, the left side signifying no pain, and the right side signifying the worst pain: no pain (0.0 - 0.4 cm), mild pain (0.5 -4.4 cm), moderate pain (4.5 - 7.4 cm) and severe pain (7.5 - 10.0 cm). | Four weeks | |
Secondary | Therapeutic Tolerability: Number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0) | Description : Incidence and duration of adverse events monitored throughout the study by physical examination and the completion of a questionnaire. It will be considered Therapeutic Tolerability when the participant does not present adverse effect of grade 3, according to the Common Terminology Criteria for Adverse Events v 4.0 | Four weeks | |
Secondary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of function. A scale used to evaluate function of the knee | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a questionnaire for the assessment of function of the affected knee. Scale describes pain in every day's life activity of the patient. Physical Function is measured by means of 17 items: using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-68 for Physical Function. Higher scores on the WOMAC indicate worse functional limitations. |
Four weeks |
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