Study Results
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-09-30
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Diphenhydramine
Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days
Diphenhydramine 5%
Diphenhydramine 5% ointment
Placebo
Vehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days
Placebo
Placebo matched to diphenhydramine 5% ointment
Interventions
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Diphenhydramine 5%
Diphenhydramine 5% ointment
Placebo
Placebo matched to diphenhydramine 5% ointment
Eligibility Criteria
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Inclusion Criteria
2. Radiographic knee OA (Kellgren-Lawrence grade \>1)
3. Age ≥ 50 years
4. VAS pain \>= 40/100 mm at baseline
5. Non-use of NSAIDs one week before the baseline
6. Symptoms present on most days for at least 3 months
Exclusion Criteria
2. Use of another topical product at the application site
3. Treatment with intraarticular hyaluronic acid within 6 months
4. Treatment with intraarticular glucocorticoid within 2 months
5. Knee injury/surgery or diagnostic arthroscopy within 3 months
6. Allergic reaction to diphenhydramine or any component of the formulation
7. Participant has clinical signs and symptoms suggestive of COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening
50 Years
ALL
No
Sponsors
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Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
OTHER
Responsible Party
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Ivan Shirinsky, MD, PhD
Head of the laboratory of immunopharmacology
Locations
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Laboratory of Clinical Immunopharmacology
Novosibirsk, , Russia
Countries
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Central Contacts
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Other Identifiers
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415-5.13.04.2021-1
Identifier Type: -
Identifier Source: org_study_id
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