Sub clinical dose if the 3 doses employed

Comparator for all active intervention arms

Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).

240mg Devil Claw

total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .

960mg/d Devil Claw

total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .

1,920mg/d Devil Claw

total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.

Placebo

Total

Sex: Female, Male

Region of Enrollment

WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.

Western Ontario and Mc Master University OA Index (WOMAC)

Subscale assessed by 100mm VAS based on five questions addressing pain in osteoarthritis using the terminators no pain (0mm) to extreme pain (100mm). a higher score therefore indicates more severe pain. This outcome was recorded at baseline, week 8 and week 16 (end of treatment). The outcome for this study was reported as the change in WOMAC pain score from baseline to end of treatment at week 16.

Pain Subscale on Western Ontario and Mc Master University OA Index

Subscale assessed by 100mm VAS based on twelve questions addressing disability in osteoarthritis with a higher score indicating worse symptoms. The VAS used terminators of no disability (0mm) to extreme disability (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.

Disability Subscale on The Western Ontario and Mc Master University OA Index

Subscale assessed by 100mm VAS based on two questions addressing stiffness in osteoarthritis;a higher score indicating worse symptoms. The VAS used terminators of no stiffness (0mm) to extreme stiffness (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.

Stiffness Subscale on the The Western Ontario and Mc Master University OA Index

Quality of Life assessment containing 8 scales clustered into 2 summary scales: physical health and mental health. Each question is scored out from 0 (indicating worst health) to 100 (indicating best health). Mean scores for the 8 scales (total scores/no questions completed) are calculated to give a total score for each of the two summary scales between 0 (worst health) and 100 (best health). SF36 was recorded at baseline, week 8 and at the end of treatment at week 16. we reported the change from baseline to end of treatment as the outcome.

Short Form-36 (SF-36)

To assess changes in the subject's well-being based on 7 point likert scale ranging from very poor (0 point) to very good (7 point). Outcome was recorded at baseline, week 8 and end of treatment at week 16. We reported outcome as the change in patient global assessment from baseline to end of treatment at week 16.

Patient Global Assessment

Questionnaire to assess changes in attitudes and health beliefs to CAM.the questionnaire as 17 questions, each scored on a 7 point likert scale from strongly disagree to strongly agree; a higher score indicates stronger belief in the measure. Minimum score 17, maximum score 119

Complementary and Alternative Medicine Beliefs Inventory

To identify Group differences between the number of adverse event recorded by patient for both serious and non serious adverse events, as well as events considered being attributable to the study medication.

Adverse Event Reporting

Overall Study

Dr Sarah Brien

Osteoarthritis, Knee

Osteoarthritis, Hip

Dose ranging study so will elucidate dose Frequency is four times daily

Devil Claw

Placebo has same dosing freq as for active intervention and for same time period

Wellcome Trust Clinical Research Facility, Southampton General Hospital

Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis

A Randomized, Double-blind, Placebo-controlled, Dose-ranging Two- Centre Study to Evaluate the Efficacy and Safety of Devil's Claw in the Treatment of Knee and Hip Osteoarthritis

harpagophytum zeyheri/inflamação

Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis

O mais completo banco de dados de ervas medicinais apoiado pela ciência