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Survey on oral administration of black cumin on relieving clinical symptoms of knee osteoarthritis.

Phase 3
Conditions
knee osteoarthritis.
Gonarthrosis, unspecified
Registration Number
IRCT2013111515408N1
Lead Sponsor
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
120
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain. Timepoint: before the intervention,weeks 2,4,8 & 12 After intervention. Method of measurement: KOOS Pain.
Secondary Outcome Measures
NameTimeMethod
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.
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