Comarum Palustre in Knee Osteoarthritis and Diabetes

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530930
• Other study ID #: LCI001
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2018
• Est. completion date: November 25, 2018

Study information

• Verified date: May 2019
• Source: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 25, 2018
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Osteoarthritis

Intervention

Drug:
• Comarum Palustre
Comarum Palustre tablets 500 mg BID, 1 month

Locations

Country	Name	City	State
Russian Federation	Laboratory of Clinical Immunopharmacology	Novosibirsk

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Intermittent and Constant Osteoarthritis Pain self-report questionnaire	Pain measure: Scale range 0-100 with higher scores indicating worse pain	Baseline, 4 weeks
Secondary	Changes in serum levels of aggrecan	serum levels of aggrecan measured in ng/ml	Baseline, 4 weeks
Secondary	Changes in serum levels of antibodies to collagen type II	serum levels of antibodies to collagen type II measured AU/ml	Baseline, 4 weeks
Secondary	Changes in serum levels of C-reactive protein	serum levels of C-reactive protein (CRP), g/l	Baseline, 4 weeks
Secondary	Changes in histamine levels	serum levels of histamine in ng/ml	Baseline, 4 weeks
Secondary	Changes in inflammation biomarkers	serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) ? in pg/ml	Baseline, 4 weeks
Secondary	Changes in neopterin levels	serum neopterin measured in nmol/L	Baseline, 4 weeks
Secondary	Changes in lipid biomarkers	serum total cholesterol, HDL, and LDL measured in mmol/L	Baseline, 4 weeks
Secondary	changes in diabetes control	Glycated haemoglobin (HbA1c)	Baseline, 4 weeks
Secondary	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
Secondary	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