Knee OsteoarthritisPhase 2NCT04511195
Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis
A Phase 2 study testing Standardized extract of Sphaeralcea angustifolia and Diclofenac Sodium Gel in people with Knee Osteoarthritis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Standardized extract of Sphaeralcea angustifolia and Diclofenac Sodium Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jul 2020to 16 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General Regional Number 1 de l IMSS en Cuernavaca, Mor.
Cuernavaca, Morelos, 62200
Ofelia Romero-Cerecero, Dr, +527773612194 ext. 1, orcerecero@yahoo.com.mx
Jaime Tortoriello, Dr, +527771340147, jtortora2@yahoo.es
About this study
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:
Read more
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
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Standardized extract of Sphaeralcea angustifolia, Diclofenac Sodium Gel
- Keywords
- Inflammation, phytopharmaceutical, outpatients, arthritis
- Medical subject headings
- Osteoarthritis, Knee, Inflammation, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized extract of Sphaeralcea angustifoliaDietary supplement
Also called Sphaeralcea angustifolia standardized extract
Each patient will be treated topically with a gel containing the Sphaeralcea angustifolia extract three times a day for 4 weeks. Sphaeralcea angustifolia extract is standardized in its active compounds content: Sphaeralcic acid and scopoletin
Diclofenac Sodium GelDrug
Also called Diclofenac
Each patient will be treated topically with a gel containing 2% diclofenac three times a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sphaeralcea angustifolia standardized extract | Experimental | Patients with diagnosis of knee osteoarthritis will be included in the experimental group and assigned the treatment consisting of a topical administration of a gel elaborated with the pharmaceutical formulation prepared with a standardized extract from S. angustifolia, which will be administered three times a day for four weeks. Receives: Dietary Supplement: Standardized extract of Sphaeralcea angustifolia |
| Diclofenac 2 % | Active comparator | Patients with diagnosis of knee osteoarthritis will be included in the control group and assigned the treatment consisting of a topical administration of a gel elaborated with 2% diclofenac, which be administered three times a day for four weeks Receives: Drug: Diclofenac Sodium Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Four weeks
Secondary outcomes (2)
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
Measured: Four weeks
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start10 Jul 2020
- Primary completion16 Jan 2021 (estimated)
- Study completion16 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the two groups: the experimental group receiving a phytopharmaceutical elaborated with the standardized extract from Sphaeralcea angustifolia, and a control group receiving an identical formulation containing Diclofenac
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ofelia Romero-Cerecero, MD, PhD, Principal investigator, Southern Biomedical Research CenterSusana Navarrete, Dr., Study chair, Coordinación de Investigación en Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511195
- Sponsor's protocol ID
- Sphaeralcea
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Publications
Perez-Hernandez J, Nicasio-Torres MDP, Sarmiento-Lopez LG, Rodriguez-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.
PubMed 32625002Perez-Hernandez J, Gonzalez-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.
PubMed 24488717Romero-Cerecero O, Meckes-Fischer M, Zamilpa A, Enrique Jimenez-Ferrer J, Nicasio-Torres P, Perez-Garcia 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.
PubMed 23528365Serrano-Roman J, Nicasio-Torres P, Hernandez-Perez E, Jimenez-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.
PubMed 32045824Meckes 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. doi: 10.1016/j.phymed.2003.06.002.
PubMed 15330501
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04511195
- Acronym / sponsor ID
- Sphaeralcea
- Conditions
- Knee Osteoarthritis
- Keywords
- Inflammation, phytopharmaceutical, outpatients, arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 16 Jan 2021 (estimated)
- Study completion
- 16 Jun 2021 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of the two groups: the experimental group receiving a phytopharmaceutical elaborated with the standardized extract from Sphaeralcea angustifolia, and a control group receiving an identical formulation containing Diclofenac
| Arm | Type | Receives |
|---|---|---|
| Sphaeralcea angustifolia standardized extract | Experimental | Dietary Supplement: Standardized extract of Sphaeralcea angustifoliaPatients with diagnosis of knee osteoarthritis will be included in the experimental group and assigned the treatment consisting of a topical administration of a gel elaborated with the pharmaceutical formulation prepared with a standardized extract from S. angustifolia, which will be administered three times a day for four weeks. |
| Diclofenac 2 % | Active comparator | Drug: Diclofenac Sodium GelPatients with diagnosis of knee osteoarthritis will be included in the control group and assigned the treatment consisting of a topical administration of a gel elaborated with 2% diclofenac, which be administered three times a day for four weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized extract of Sphaeralcea angustifoliaAlso: Sphaeralcea angustifolia standardized extractEach patient will be treated topically with a gel containing the Sphaeralcea angustifolia extract three times a day for 4 weeks. Sphaeralcea angustifolia extract is standardized in its active compounds content: Sphaeralcic acid and scopoletin | Dietary supplement | Sphaeralcea angustifolia standardized extract |
| Diclofenac Sodium GelAlso: DiclofenacEach patient will be treated topically with a gel containing 2% diclofenac three times a day for 4 weeks. | Drug | Diclofenac 2 % |
Primary outcome
Therapeutic efficacy: Improvement of the clinical condition higher than 80 %. It will be measured by means of Visual Analogue Scale of pain.
Time frame: Four weeks
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).
2 secondary outcomes
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)
Time frame: Four weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of function. A scale used to evaluate function of the knee
Time frame: Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 32625002Perez-Hernandez J, Nicasio-Torres MDP, Sarmiento-Lopez LG, Rodriguez-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.
- Background: PubMed 24488717Perez-Hernandez J, Gonzalez-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.
- Background: PubMed 23528365Romero-Cerecero O, Meckes-Fischer M, Zamilpa A, Enrique Jimenez-Ferrer J, Nicasio-Torres P, Perez-Garcia 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.
- Background: PubMed 32045824Serrano-Roman J, Nicasio-Torres P, Hernandez-Perez E, Jimenez-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.
- Background: PubMed 15330501Meckes 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. doi: 10.1016/j.phymed.2003.06.002.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofelia Romero-Cerecero, MD, PhD principal investigator
Southern Biomedical Research Center
Susana Navarrete, Dr. study chair
Coordinación de Investigación en Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standardized extract of Sphaeralcea angustifolia and Diclofenac Sodium Gel in people with Knee Osteoarthritis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofelia Romero-Cerecero, MD, PhD (+527773612155 ext. 1, orcerecero@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic efficacy: Improvement of the clinical condition higher than 80 %. It will be measured by means of Visual Analogue Scale of pain. (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511195, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.