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OsteoarthritisPhase 4NCT03530930

Comarum Palustre in Knee Osteoarthritis and Diabetes

A Phase 4 study testing Comarum Palustre in people with Osteoarthritis and Diabetes Mellitus, run by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Osteoarthritis, Diabetes Mellitus
What is being tested?
Comarum Palustre
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteRussia
Study dates
29 Jun 2018to 25 Nov 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
  • diagnosis of type 2 diabetes mellitus

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Laboratory of Clinical Immunopharmacology

    Novosibirsk, 630047

Other trials in Russia

About this study

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

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.

Read the detailed 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.

Being tested
Comarum Palustre
Medical subject headings
Osteoarthritis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comarum PalustreDrug

    Also called Potentilla palustris

    Comarum Palustre tablets 500 mg BID, 1 month

Study groups in NCT03530930
Study groupRoleWhat they receive
Comarum PalustreExperimentalPatients taking Comarum Palustre together with conventional treatment for osteoarthritis
Receives: Drug: Comarum Palustre

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 4 weeks

Secondary outcomes (15)

  1. 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.

    Measured: Baseline, 4 weeks

  2. 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.

    Measured: Baseline, 4 weeks

  3. 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.

    Measured: Baseline, 4 weeks

  4. 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.

    Measured: Baseline, 4 weeks

  5. Intermittent and Constant Osteoarthritis Pain self-report questionnaire

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

    Measured: Baseline, 4 weeks

  6. Changes in serum levels of aggrecan

    serum levels of aggrecan measured in ng/ml

    Measured: Baseline, 4 weeks

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

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

    Measured: Baseline, 4 weeks

  8. Changes in serum levels of C-reactive protein

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

    Measured: Baseline, 4 weeks

  9. Changes in histamine levels

    serum levels of histamine in ng/ml

    Measured: Baseline, 4 weeks

  10. Changes in inflammation biomarkers

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

    Measured: Baseline, 4 weeks

  11. Changes in neopterin levels

    serum neopterin measured in nmol/L

    Measured: Baseline, 4 weeks

  12. Changes in lipid biomarkers

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

    Measured: Baseline, 4 weeks

  13. changes in diabetes control

    Glycated haemoglobin (HbA1c)

    Measured: Baseline, 4 weeks

  14. 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.

    Measured: Baseline, 4 weeks

  15. 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.

    Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start29 Jun 2018
  3. Primary completion25 Nov 2018
  4. Study completion25 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03530930
Sponsor's protocol ID
LCI001
Status last verified
May 2019
First submitted
7 Dec 2017
Last updated
15 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Comarum Palustre in people with Osteoarthritis and Diabetes Mellitus, run by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Visual Analogue Scale for Pain (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03530930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.

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