Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511195
Status:
UNKNOWN
Last Update Posted:
2020-08-13
First Post:
2020-08-05
Brief Title:
Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis
Sponsor:
Coordinación de Investigación en Salud Mexico
Organization:
Coordinación de Investigación en Salud Mexico
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None