Comarum Palustre in Knee Osteoarthritis and Diabetes

Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis

Diabetes Mellitus

Treatments

Drug: Comarum Palustre

Study type

Interventional

Funder types

Other

Identifiers

NCT03530930

LCI001

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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