Comarum Palustre in Knee Osteoarthritis and Diabetes
- Conditions
- OsteoarthritisDiabetes Mellitus
- Interventions
- Drug: Comarum Palustre
- Registration Number
- NCT03530930
- Lead Sponsor
- Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
- diagnosis of type 2 diabetes mellitus
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Comarum Palustre Comarum Palustre Patients taking Comarum Palustre together with conventional treatment for osteoarthritis
- Primary Outcome Measures
Name Time Method Change From Baseline in Visual Analogue Scale for Pain Baseline, 4 weeks The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.
- Secondary Outcome Measures
Name Time Method Changes in neopterin levels Baseline, 4 weeks serum neopterin measured in nmol/L
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL) Baseline, 4 weeks 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.
Quality of life with the The Short Form (36) Health Survey score Baseline, 4 weeks 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.
Changes in serum levels of aggrecan Baseline, 4 weeks serum levels of aggrecan measured in ng/ml
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain Baseline, 4 weeks 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.
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms Baseline, 4 weeks 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.
Intermittent and Constant Osteoarthritis Pain self-report questionnaire Baseline, 4 weeks Pain measure: Scale range 0-100 with higher scores indicating worse pain
Changes in serum levels of antibodies to collagen type II Baseline, 4 weeks serum levels of antibodies to collagen type II measured AU/ml
Changes in serum levels of C-reactive protein Baseline, 4 weeks serum levels of C-reactive protein (CRP), g/l
Changes in histamine levels Baseline, 4 weeks serum levels of histamine in ng/ml
Changes in inflammation biomarkers Baseline, 4 weeks serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) γ in pg/ml
changes in diabetes control Baseline, 4 weeks Glycated haemoglobin (HbA1c)
Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P) Baseline, 4 weeks 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.
Changes in lipid biomarkers Baseline, 4 weeks serum total cholesterol, HDL, and LDL measured in mmol/L
Patient global assessment of osteoarthritis Baseline, 4 weeks The Visual Analogue Scale for the Patient global assessment of osteoarthritis varies from 0 to 10 cm. Higher values represent worse outcomes.
Trial Locations
- Locations (1)
Laboratory of Clinical Immunopharmacology
🇷🇺Novosibirsk, Russian Federation