knee osteoarthritis. Gonarthrosis, unspecified
Conditions
Interventions
Intervention 1: intervention group:2 cap.500 mg of modabbar black cumin, , 20 " before breakfast & 1 before lunch & dinner, for 12 weeks. Intervention 2: for both intervention & control group: tablet
Treatment - Drugs
Treatment - Other
Placebo
intervention group:2 cap.500 mg of modabbar black cumin, , 20 " before breakfast & 1 before lunch & dinner, for 12 weeks.
for both intervention & control group: tablet 500 mg, PRN, up to 4 gr/day for 12 weeks.
control group:2 cap.500 mg of starch , 20 " before breakfast & 1 before lunch & dinner, for 12 weeks.
Sponsors
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes
Eligibility
Sex/Gender
All
Age
40 Years to 69 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria : Patients greater than 40 and less than 80 years old who have ACR clinical and radiological ACR criteria and VAS> 40mm after a drug wash out period . Radiological ACR criteria include : ? knee pain plus at least One of four following criteria ? ? 50 years of age, morning stiffness less than 30 minutes ? ?crepitus osteophytes. exclusion criteria : 1 . History of rheumatoid arthritis , gout , CPPD 2. Previous surgery on the affected knee 3 .Severe cardiovascular disease grade 3 and 4.4 . malignancy.5 . Liver disease ( bleeding esophageal varices , encephalopathy , ascites ) 6 . Symptomatic gallstone (in history ) 7 . Severe renal disease (serum creatinine 3 mg / dl) 8.administration of oral corticosteroid 4 weeks before 9 . More than 325 mg daily NSAID intake 10 . receiving any central nervous system depressant , including benzodiazepines , barbiturates and narcotics 11. Intra-articular treatment received 3 months ago.12 .Intaking Piaschledine or glucosamine . 13.Not tendency for drug taking. 14. Lack of willingness or ability of patients to complete the questionnaire used in the study. 15 . Older than 79 years .16. Pregnancy and lactation. 17 . patients with a history of asthma or respiratory allergies . 18. patients receiving insulin.19. . Patients receiving warfarin , clopidogrel 20 . Or any other medications that is not permitted , according to pharmacologist's view. 21 . Lack of persistence of above Nineteen . 22 . Patient's unwillingness to continue participation in the study. 23 . Occurrence of any of the threatening side effects that maybe don't predicted.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain. Timepoint: before the intervention,weeks 2,4,8 & 12 After intervention. Method of measurement: KOOS Pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Function in daily living. Timepoint: before interventin & weeks 2,4,8,12 after intervention. Method of measurement: KOOS ADL.;Other Symptoms. Timepoint: before interventin & weeks 2,4,8,12 after intervention. Method of measurement: KOOS Symptoms.;Function in Sport and Recreation. Timepoint: before interventin & weeks 2,4,8,12 after intervention. Method of measurement: KOOS Sport/Rec.;Knee-related Quality of Life. Timepoint: before interventin & weeks 2,4,8,12 after intervention. Method of measurement: KOOS QOL.;Globall physition assessment of treatment. Timepoint: weeks 2,4,8 &12. Method of measurement: VAS.;Globall patient assessment of treatment. Timepoint: weeks 2,4,8 &12. Method of measurement: VAS.;Number of acetaminophen tablets used. Timepoint: weeks 2,4,8 &12. Method of measurement: Question from patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAnahita Ghourchian M.D
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Outcome results
None listed