Primary osteoarthritis of the knee. Unilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention group: Topical application of a formulated herbal gel containing extracts of Lawsonia inermis (Henna), Ricinus communis (Castor), Nigella sativa (Black seed), and Biebersteinia multifida
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Primary osteoarthritis in at least one knee, confirmed by radiological criteria on a knee radiograph (Kellgren-Lawrence grades 1, 2, and 3). Presence of pain for a minimum of two weeks prior to the initiation of therapy. Age between 40 and 80 years. Performance of routine laboratory tests (CBC with differential, FBS, LFT, BUN, Cr, ESR, CPK, serum calcium and phosphorus) and, in suspected cases, thyroid and coagulation tests (INR, PTT, PT) to rule out secondary causes.
Exclusion criteria
Exclusion criteria: Secondary osteoarthritis or suspicion thereof. Active hepatic or renal disease. Peptic ulcer disease (PUD). Diabetes mellitus (uncontrolled). Thyroid or parathyroid disease/disorder. Coagulopathies or use of anticoagulant medications. A history of ischemic or hemorrhagic stroke. A history of deep vein thrombosis (DVT). Hypersensitivity to any form of anti-inflammatory drugs. Acute trauma. A history of alcohol consumption or drug abuse. Presence of dermatological diseases, infection, or wounds at the intended site of topical drug application. Use of corticosteroids by any route/for any indication. Concurrent use of any other topical medication at the intended site of drug application. Oral use of any other analgesics or compounds effective in the treatment of osteoarthritis within 10 days prior to the study initiation. Pregnancy. Chronic therapy with immunosuppressive drugs/medications. Receipt of corticosteroids within the past 3 months. Administration of non-steroidal anti-inflammatory drugs (NSAIDs) within the preceding 15 days. Bilateral knee osteoarthritis requiring treatment in both knees. Poorly-controlled diabetes mellitus. Blood dyscrasia. Allergy to hyaluronan (HA) or avian proteins (should these be used in the intervention).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in knee pain intensity score based on the Numeric Rating Scale (NRS). Timepoint: Before intervention (baseline), 4 weeks after starting the intervention, and 2 weeks after the end of intervention (week 6). Method of measurement: Knee pain intensity will be measured using a 10 cm straight ruler (Numeric Rating Scale) where 0 indicates "no pain" and 10 indicates "unbearable pain". Patients will mark their pain level on the scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Asghar Hamidi
Iran University of Medical Sciences
Outcome results
None listed