Comarum Palustre in Knee Osteoarthritis and Diabetes
Analgesic, Antiinflammatory and Metabolic Effects of Comarum Palustre in Patients With Osteoarthritis and Diabetes Mellitus
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2018
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2017
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedStudy Start
First participant enrolled
June 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2018
CompletedMay 15, 2019
May 1, 2019
5 months
December 7, 2017
May 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
Baseline, 4 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
Baseline, 4 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
Baseline, 4 weeks
Quality of life with the The Short Form (36) Health Survey score
Baseline, 4 weeks
Intermittent and Constant Osteoarthritis Pain self-report questionnaire
Baseline, 4 weeks
- +10 more secondary outcomes
Study Arms (1)
Comarum Palustre
EXPERIMENTALPatients taking Comarum Palustre together with conventional treatment for osteoarthritis
Interventions
Comarum Palustre tablets 500 mg BID, 1 month
Eligibility Criteria
You may qualify if:
- osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
- diagnosis of type 2 diabetes mellitus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Clinical Immunopharmacology
Novosibirsk, 630047, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ivan Shirinsky
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 7, 2017
First Posted
May 21, 2018
Study Start
June 29, 2018
Primary Completion
November 25, 2018
Study Completion
November 25, 2018
Last Updated
May 15, 2019
Record last verified: 2019-05