Comarum Palustre in Knee Osteoarthritis and Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Diabetes Mellitus

Intervention / Treatment
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* Drug: Comarum Palustre


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comarum Palustre<br>Patients taking Comarum Palustre together with conventional treatment for osteoarthritis | Drug: Comarum Palustre<br>* Comarum Palustre tablets 500 mg BID, 1 month<br>* Other names: Potentilla palustris;|

What is the study measuring?
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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 |