Clinical trial NCT03530930: Comarum Palustre in Knee Osteoarthritis and Diabetes
Official title: Analgesic, Antiinflammatory and Metabolic Effects of Comarum Palustre in Patients With Osteoarthritis and Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Diabetes Mellitus
Lead sponsor: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Visual Analogue Scale for Pain
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
timeFrame: Baseline, 4 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
timeFrame: Baseline, 4 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
timeFrame: Baseline, 4 weeks
measure: Quality of life with the The Short Form (36) Health Survey score
timeFrame: Baseline, 4 weeks
measure: Intermittent and Constant Osteoarthritis Pain self-report questionnaire
timeFrame: Baseline, 4 weeks
measure: Changes in serum levels of aggrecan
timeFrame: Baseline, 4 weeks
measure: Changes in serum levels of antibodies to collagen type II
timeFrame: Baseline, 4 weeks
measure: Changes in serum levels of C-reactive protein
timeFrame: Baseline, 4 weeks
measure: Changes in histamine levels
timeFrame: Baseline, 4 weeks
measure: Changes in inflammation biomarkers
timeFrame: Baseline, 4 weeks
measure: Changes in neopterin levels
timeFrame: Baseline, 4 weeks
measure: Changes in lipid biomarkers
timeFrame: Baseline, 4 weeks
measure: changes in diabetes control
timeFrame: Baseline, 4 weeks
measure: Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)
timeFrame: Baseline, 4 weeks
measure: Patient global assessment of osteoarthritis
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Laboratory of Clinical Immunopharmacology
Study officials:
affiliation: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
name: Ivan Shirinsky
role: PRINCIPAL_INVESTIGATOR
References: