Skip to main content
OpenTrials
Completed

NCT Number: NCT03530930

Comarum Palustre in Knee Osteoarthritis and Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laboratory of Clinical Immunopharmacology

Novosibirsk, 630047, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comarum Palustre

Drug

Comarum Palustre tablets 500 mg BID, 1 month

Other names: Potentilla palustris

Primary outcomes

  1. Change From Baseline in Visual Analogue Scale for Pain

    Time frame: Baseline, 4 weeks

    The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain

    Time frame: 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.

  2. Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)

    Time frame: 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.

  3. Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms

    Time frame: 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.

  4. Quality of life with the The Short Form (36) Health Survey score

    Time frame: 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.

  5. Intermittent and Constant Osteoarthritis Pain self-report questionnaire

    Time frame: Baseline, 4 weeks

    Pain measure: Scale range 0-100 with higher scores indicating worse pain

  6. Changes in serum levels of aggrecan

    Time frame: Baseline, 4 weeks

    serum levels of aggrecan measured in ng/ml

  7. Changes in serum levels of antibodies to collagen type II

    Time frame: Baseline, 4 weeks

    serum levels of antibodies to collagen type II measured AU/ml

  8. Changes in serum levels of C-reactive protein

    Time frame: Baseline, 4 weeks

    serum levels of C-reactive protein (CRP), g/l

  9. Changes in histamine levels

    Time frame: Baseline, 4 weeks

    serum levels of histamine in ng/ml

  10. Changes in inflammation biomarkers

    Time frame: Baseline, 4 weeks

    serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) γ in pg/ml

  11. Changes in neopterin levels

    Time frame: Baseline, 4 weeks

    serum neopterin measured in nmol/L

  12. Changes in lipid biomarkers

    Time frame: Baseline, 4 weeks

    serum total cholesterol, HDL, and LDL measured in mmol/L

  13. changes in diabetes control

    Time frame: Baseline, 4 weeks

    Glycated haemoglobin (HbA1c)

  14. Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)

    Time frame: 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.

  15. Patient global assessment of osteoarthritis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.