Patients with primary knee osteoarthritis diagnosed radiographically by a physician, with disease severity classified as Kellgren Lawrence grade 1 to 2. knee osteoarthritis
Conditions
Interventions
Topical application of Justicia gendarussa Burm.f. Medicated Emulsion gel, 4 g applied to painful knee four times daily (morning, noon, evening, and at bedtime) for 2 weeks in each treatment period of
Experimental Drug,Active Comparator Drug
Justicia gendarussa Burm.f. Medicated Emulsion gel,Diclofenac Emulsion gel
Sponsors
Chao Phya Abhaibhubejhr Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 50 to70 years with primary knee osteoarthritis, diagnosed radiographically by a physician, with disease severity classified as Kellgren Lawrence grade 1 to 2. Participants must have unilateral or bilateral knee pain of moderate intensity (VAS score 4 to 6). The more symptomatic or severe knee will be selected for study treatment. 2. Willingness to participate in the study. Participants must be able to speak, read, and write Thai. In cases where participants cannot read or write, a caregiver who can assist with reading and recording data will be required for treatment assessment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with septic arthritis or open wounds around the knee. 2. Patients with a known allergy to plants in the Acanthaceae family or to diclofenac. 3. Patients requiring treatment with any of the following medications during the study period: -Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac, naproxen, loxoprofen, meloxicam, celecoxib, or etoricoxib. -Opioid analgesics, such as tramadol. -Symptomatic slow-acting drugs for osteoarthritis (SYSADOA), including glucosamine sulfate, chondroitin sulfate, diacerein, and hyaluronic acid. -Anticoagulant drugs, such as warfarin and heparin. 4. Patients who received intra-articular hyaluronic acid or intra-articular corticosteroid injections within the past six months. 5. Patients with comorbid systemic conditions that affect mobility, including severe or established osteoporosis, gout, rheumatoid arthritis, systemic lupus erythematosus (SLE), Parkinson disease, neuropathic pain, peripheral neuropathy, and cerebrovascular disease or stroke. 6. Patients with severe comorbidities such as hepatitis or abnormal liver enzymes, chronic kidney disease stages 3 to 5, inflammatory skin diseases around the knee, or peptic ulcer disease. 7. Patients diagnosed with schizophrenia characterized by disturbances in thought, perception, communication, and behavior, such as delusions, hallucinations, auditory hallucinations, or communication impairments. 8. Pregnant or lactating women. 9. Patients requiring concomitant treatments during the study period, such as physical therapy, massage, or hot/cold compress therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain intensity at 2 weeks after end of the intervention Visual Analog Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| The Western Ontario and McMaster Universities Osteoarthritis Index, knee swelling, analgesic use, adverse events, satisfaction at 2 weeks after end of the intervention Thai version of the modified Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and Daily symptom diary | — |
Countries
Thailand
Contacts
Public ContactPakakrong Kwankhao
Chao Phya Abhaibhubejhr Hospital
Outcome results
None listed