Study the Effect of Topical Application of 1% Stachys lavandulifolia Extract Gel vs Diclofenac Gel in Knee Osteoarthritis on the pain and functional disability in patients with primary monoarticular knee osteoarthritis

Phase 2

Conditions: primary monoarticular knee osteoarthritis.
Osteoarthritis, unspecified site

Registration Number: IRCT20190125042486N1

Lead Sponsor: Shahre-kord University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 150

Inclusion Criteria

A definite diagnosis of primary osteoarthritis in a knee based on the doctor's diagnostic criteria
the existence of pain at least for two weeks before beginning treatment
the age range between 45 years to 75 years old

Exclusion Criteria

Primary osteoarthritis in both patient's knees
Acute disease in liver or kidney
Ulcer pepticemia
Diabetes
Thyroid or parathyroid disease
Rheumatic arthritis
coagulation disease or consumption of anticoagulant drugs
History of ischemic stroke or hemorrhage
History of deep vein thrombosis
History of intra-articular injection during the last 6 weeks
Sensitivity to each form of anti-inflammatory drugs
Acute and pregnancy trauma
History of alcohol use and drug abuse
Skin diseases, infection or ulcers in the location of tropical use of medication
Oral use of other anti-inflammatory drugs and other effective compounds in the treatment of osteoarthritis 10 days before the beginning of the study
History of fracture or knee surgery

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain and functional disability. Timepoint: Six weeks. Method of measurement: Data were collected by interview, Western Ontario and McMaster Universities Arthritis Index Standard Questionnaire (WOMAC), and Vase Analog scale(VAS).

Secondary Outcome Measures

Name	Time	Method
Patient's function status. Timepoint: 4 times and days 0, 14,28, 42. Method of measurement: intensity of pain by Visual Analog Scale (VAS) scale and the rate of pain on the patient,s function by Western Ontario and McMaster Universities Arthritis Index(WOMAC) questionnaire were measured.