Osteoarthritis. Arthrosis, unspecified
Conditions
Interventions
Intervention 1: Pistacia atlantica oleoresin skin ointment is administered to a group of about 50 patients every 8 hours on the knee for 1 month. Intervention 2: Placebo skin ointment is administered
Treatment - Drugs
Placebo
Pistacia atlantica oleoresin skin ointment is administered to a group of about 50 patients every 8 hours on the knee for 1 month.
Placebo skin ointment is administered to another group of about 50 patients every 8 hours on the knee for 1 month.
Sponsors
Vice Chancellor for Research, ACECR Institute of Medicinal Plants
Vice Chancellor for Research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: male or female patients with 1 or 2 knees osteoarthritis according to the American College of Rheumatology criteria after physical examination and knee joint radiography, age of 40 to 85 years, flare of the disease after oral non-steroidal anti-inflammatory drug or acetaminophen discontinuation which have been used at least 3 days a week during the past month (flare means increase of at least 2 scores in the total pain subscale score in the beginning of the study.), Western Ontario and McMaster Universities (WOMAC) pain subscale index at least 9 out of 20 in the beginning of the study. Exclusion criteria: secondary osteoarthritis (due to a definite disease); arthroscopy; surgery; knee joint injection during the past 6 months; history of knee replacement surgery; any serious systemic disease (such as concomitant infections, cardiovascular, hepatic and renal diseases); any other chronic inflammatory disease; intake of any other supplement except multivitamin; intake of non-steroidal anti-inflammatory drugs; intake of any steroidal drug, skeletal muscle relaxing drug, anti-depressant drugs, glucosamine, chondroitin, tramadol and topical analgesic drugs like capsaicin and generally any analgesic drug; any history of alcohol, drug and narcotics abuse; skin disease at the site of topical use of the oleoresin or placebo (knee); having fibromyalgia and other debilitating diseases affecting the knee; pregnant women; women planning pregnancy; lactating women.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extent of arthritis. Timepoint: Before intervention and 1 month after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index questionnaire.;Extent of joint pain. Timepoint: Before intervention and 1 month after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index questionnaire.;Extent of joint stiffness. Timepoint: Before intervention and 1 month after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index questionnaire.;Extent of physical function. Timepoint: Before intervention and 1 month after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose of acetaminophen. Timepoint: Before intervention and 1 month after intervention. Method of measurement: Daily recording of the acetaminophen dose by the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Saeed Kianbakht
ACECR Institute of Medicinal Plants
Outcome results
None listed