Comarum Palustre in Knee Osteoarthritis and Diabetes

Analgesic, Antiinflammatory and Metabolic Effects of Comarum Palustre in Patients With Osteoarthritis and Diabetes Mellitus

The study evaluates analgesic, antiinflammatory and metabolic effects of Comarum palustre in patients with knee osteoarthritis (OA) and diabetes mellitus. Patients with osteoarthritis will receive Comarum palustre together with conventional treatment of osteoarthritis and diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Osteoarthritis
• Intervention / Treatment: Drug: Comarum Palustre

Detailed Description

Comarum palustre have been shown to exert analgesic properties in patients with knee osteoarthritis not responding to diclofenac. In animal models comarum palustre showed anti-inflammatory, immunomodulatory, analgesic, antioxidant, antihistamine, and membrane-stabilizing effects. Thus, pleiotropic properties of Comarum Palustre may provide a rationale for this use in patients having both osteoarthritis and diabetes mellitus. In this group of patients Comarum Palustre may not only relieve OA-related pain but reduce systemic inflammation, decrease progression of atherosclerosis and diabetes complications.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630047
    • Laboratory of Clinical Immunopharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
• diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

• use of NSAIDs one month prior to study entry (paracetamol is allowed)
• pregnancy and lactation
• increased sensitivity to the study drug
• clinically significant renal function impairment
• use of antidepressants
• diagnosis of bipolar disorder
• use of symptomatic slow acting drugs of OA (SYSADOA) one month prior to study entry
• any condition which may lead to difficulties to participation in the study from the viewpoint of Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comarum Palustre; Patients taking Comarum Palustre together with conventional treatment for osteoarthritis	Drug: Comarum Palustre; Comarum Palustre tablets 500 mg BID, 1 month; Other Names: Potentilla palustris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Visual Analogue Scale for Pain	The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.	Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain	KOOS Pain consists of 9 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	Baseline, 4 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)	KOOS ADL consists of 17 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	Baseline, 4 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms	KOOS Symptoms consists of 7 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	Baseline, 4 weeks
Quality of life with the The Short Form (36) Health Survey score	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 4 weeks
Intermittent and Constant Osteoarthritis Pain self-report questionnaire	Pain measure: Scale range 0-100 with higher scores indicating worse pain	Baseline, 4 weeks
Changes in serum levels of aggrecan	serum levels of aggrecan measured in ng/ml	Baseline, 4 weeks
Changes in serum levels of antibodies to collagen type II	serum levels of antibodies to collagen type II measured AU/ml	Baseline, 4 weeks
Changes in serum levels of C-reactive protein	serum levels of C-reactive protein (CRP), g/l	Baseline, 4 weeks
Changes in histamine levels	serum levels of histamine in ng/ml	Baseline, 4 weeks
Changes in inflammation biomarkers	serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) γ in pg/ml	Baseline, 4 weeks
Changes in neopterin levels	serum neopterin measured in nmol/L	Baseline, 4 weeks
Changes in lipid biomarkers	serum total cholesterol, HDL, and LDL measured in mmol/L	Baseline, 4 weeks
changes in diabetes control	Glycated haemoglobin (HbA1c)	Baseline, 4 weeks
Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)	The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It consists of nine questions with responses ranging from "0" (not at all) to "3" (nearly every day). The possible range is 0-27. Higher values represent worse outcome.	Baseline, 4 weeks
Patient global assessment of osteoarthritis	The Visual Analogue Scale for the Patient global assessment of osteoarthritis varies from 0 to 10 cm. Higher values represent worse outcomes.	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
• Investigators: Principal Investigator: Ivan Shirinsky, Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): November 25, 2018
• Study Completion (Actual): November 25, 2018

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Diabetes Mellitus; Osteoarthritis
• Other Study ID Numbers: LCI001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No