Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis

NCT04511195 | Unknown Phase 2 DMC

• 1 other identifier: Sphaeralcea
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Keywords

Inflammation, phytopharmaceutical, outpatients, arthritis

Outcome Measures

Primary Outcomes (1)

• 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 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)

  Four weeks

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of function. A scale used to evaluate function of the knee

  Four weeks

Study Arms (2)

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.

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

Drug: Diclofenac Sodium Gel

Interventions

Standardized extract of Sphaeralcea angustifolia DIETARY_SUPPLEMENT

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

Also known as: Sphaeralcea angustifolia standardized extract

Sphaeralcea angustifolia standardized extract

Diclofenac Sodium Gel DRUG

Each patient will be treated topically with a gel containing 2% diclofenac three times a day for 4 weeks.

Also known as: Diclofenac

Diclofenac 2 %

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Hospital General Regional Number 1 de l IMSS en Cuernavaca, Mor.

Cuernavaca, Morelos, 62200, Mexico

RECRUITING

Related Publications (5)

• 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.

  PMID: 32625002 BACKGROUND

• Perez-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.

  PMID: 24488717 BACKGROUND

• Romero-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.

  PMID: 23528365 BACKGROUND

• Serrano-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.

  PMID: 32045824 BACKGROUND

• 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. doi: 10.1016/j.phymed.2003.06.002.

  PMID: 15330501 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Inflammation; Arthritis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ofelia Romero-Cerecero, MD, PhD

  Southern Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Susana Navarrete, Dr.

  Coordinación de Investigación en Salud

  STUDY CHAIR

Central Study Contacts

Ofelia Romero-Cerecero, MD, PhD

CONTACT

+527773612155; orcerecero@yahoo.com.mx

Jaime Tortoriello, MD, PhD

CONTACT

+527771340147; jtortora2@yahoo.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both treatments present an identical appearance and are packed in white collapsible tubes, which are introduced in cardboard boxes and identified through a folio number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 13, 2020
• Study Start: July 10, 2020
• Primary Completion: January 16, 2021
• Study Completion: June 16, 2021
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)