Comarum Palustre in Knee Osteoarthritis and Diabetes

NCT ID: NCT03530930

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-29

Study Completion Date

2018-11-25

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.

Conditions

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Osteoarthritis Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Comarum Palustre

Patients taking Comarum Palustre together with conventional treatment for osteoarthritis

Group Type EXPERIMENTAL

Comarum Palustre

Intervention Type DRUG

Comarum Palustre tablets 500 mg BID, 1 month

Interventions

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Comarum Palustre

Comarum Palustre tablets 500 mg BID, 1 month

Intervention Type DRUG

Other Intervention Names

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Potentilla palustris

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Ivan Shirinsky, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivan Shirinsky

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Laboratory of Clinical Immunopharmacology

Novosibirsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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LCI001

Identifier Type: -

Identifier Source: org_study_id

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