knee osteoarthritis. Gonarthrosis
Conditions
Interventions
Intervention 1: Intervention group: Syrup of Squill Oxymel, 2 tablespoons in the morninig on empty stomach with a glass of lukewarm water for 8 weeks + Tablet of Acetaminophen up to 4 gr daily for 8 w
Treatment - Drugs
Placebo
Intervention group: Syrup of Squill Oxymel, 2 tablespoons in the morninig on empty stomach with a glass of lukewarm water for 8 weeks + Tablet of Acetaminophen up to 4 gr daily for 8 weeks.
Control group: Placebo Syrup made from brown sugar, 2 tablespoons in the morning on empty stomach with a glass of lukewarm water for 8 weeks + Tablet of Acetaminophen up to 4 gr daily for 8 weeks.
Sponsors
Traditional Medicine College of Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Age 40 to 80 years old that fill clinical and radiological criteria of ACR. after drug wash out,with VAS>40mm. clinical and radiological criteria of ACR: knee pain + osteophite in radiography + at least 1 of 3 below criteria: age up 50 years old; morning stiffness less than 30 minutes; crepitation of knee. Exclusion Criteria: history of rheumatoid arthritis and gout; history of knee surgery; patients with severe cardiovascular disease, including heart failure, advanced Class 3 and 4, sick sinus syndrome (SSS), 3rd degree atrioventricular block, Wolff Parkinson's White syndrome (WPW), ventricular tachycardia (VT), hypertrophic cardiomyopathy, aortic thoracic aneurysm; proven malignancies; GI bleeding(stomach bleeding); severe liver disease(esophageal varices and bleeding, encephalopathy, ascites); patients with Symptomatic gallstone(in history); severe renal disease(creatinine greater than 3mg / dl); joint injection of corticosteroids in the past three months; received oral corticosteroids in the past 4 weeks; oral or injectable NSAID in last seven days; received chondrotin sulfate or glucosamine, warfarin, clopidogrel, digitalis, capsaicin, quinidine, laxatives or any other drugs, according to pharmacologists opinion; pregnancy and Breast-feeding. Exit criteria during study: Not wanting to continue taking the drug by the patient for any reason; Allergy symptoms or complications to acetaminophen or squill oxymel; Any clinical condition that need to change a patient's treatment regimen.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain. Timepoint: At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention. Method of measurement: KOOS Pain and VAS.;Knee discomfort. Timepoint: At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention. Method of measurement: KOOS Scoring.;Stiffness. Timepoint: At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention. Method of measurement: KOOS Scoring.;Activites and daily living. Timepoint: At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention. Method of measurement: KOOS Scoring.;Sport and recreation function. Timepoint: At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention. Method of measurement: KOOS Scoring.;Quality of life. Timepoint: At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention. Method of measurement: KOOS Scoring and SF26 WHO. | — |
Secondary
| Measure | Time frame |
|---|---|
| SOD. Timepoint: At the beginning of intervention and 2 months later at the end of intervention. Method of measurement: Based on Lab data.;IL6. Timepoint: At the beginning of intervention and 2 months later at the end of intervention. Method of measurement: Based on Lab data.;CRP. Timepoint: At the beginning of intervention and 2 months later at the end of intervention. Method of measurement: Based on Lab data.;ESR. Timepoint: At the beginning of intervention and 2 months later at the end of intervention. Method of measurement: Based on Lab data.;WBC. Timepoint: At the beginning of intervention and 2 months later at the end of intervention. Method of measurement: Based on Lab data. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMojtaba Taheri
College of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Outcome results
None listed