The effectiveness and safety of a herbal formulation for the management of osteoarthritis of the knee

Not Applicable

Completed

• Conditions: Osteoarthritis of the knee; Musculoskeletal - Osteoarthritis; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12619000320156
• Lead Sponsor: ICM Health Research Institute, Western Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-01
• Study Completion: 2021-03-16
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Male or Female age 40 to 75
2. Clinical diagnosis of primary OA of the knee in at least one knee joint according to the American College of Rheumatology (ACR) for at least 3 months duration
3. Demonstration of radiological evidence of OA of the knee on the Kellgren and Lawrence scale Grades I to III
4. Average daily pain over 7 days to the affected knee on weight bearing activities between 30 to 80mm on a VAS (0 to 100mm) scale before baseline
5. BMI less than or equal to 35kg/m2
6. Participants normally active, not bedridden or confined to a wheelchair, able to walk 50m without the use of a walker, crutches or a cane
7. Participants able to understand and read and write in English

Exclusion Criteria

1.History of underlying inflammatory disease, arthropathy or rheumatoid arthritis or fibrosis where ESR>20 for men and >30 for women.
2.Gout or pseudogout within the last 3 months, and/or history of gout in the knee joint. Hyperuricaemia (440 micro mol/l) and /or high uric acid levels >380 micro mol/l
3.History of trauma to the knee affected by OA
4.Use of anticoagulants, systemic or intra-articular corticosteroid injections within the preceding 3 months; arthroscopy within preceding 3 months.
5.Hepatic or renal impairment within the last 6 months
6.Uncontrolled hypertension, congestive heart failure, malignancies, haematological disorders or neurological disorders
7.Have had major surgery in the past month or major surgery scheduled in the next 3 months
8.Pregnant or lactating females
9.Use of other supplements for OA (e.g. chondroitin, glucosamine, curcumin, omega-3 fatty acids)
10.Use of NSAID’s or analgesics for osteoarthritis including washout period of at least 3 days, including both oral and topical formulations
11.Disability by law (blindness, deafness, cognitive deficits, mental deficits, physical deficits)
12.Alcohol intake > 2 standard drinks per day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain using the 100mm visual analogue scale[average daily pain over 7 days on the 100mm VAS from baseline to week 12. 7 day assessments will be conducted 7 days prior to baseline, at week 4 and week 12.]

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[Week 1, 4, 8 and 12 and followup at week 16];Participant Global Assessment (PGA) of arthritis questionnaire<br>[Baseline and Week 12];Comprehensive Osteoarthritis Test (COAT) Questionnaire[Baseline, Days 1-7, week 4 and 12];Quality of life assessment using Short Form 12 (SF-12)[Baseline and Week 12];Physical performance test - 4 x 10 metre Fast Paced Walk Test[baseline, week 4 and week 12];Physical performance test - 30second Chair Sit to Stand test[baseline, week 4 and week 12];inflammatory blood marker - high sensitivity C-reactive protein (Hs-CRP)[Baseline and week 12 ];Blood Tests to assess safety of intervention - hepatic and renal function, full blood count and erythrocyte sedimentation rate[baseline and week 12];Pain VAS 100mm over 48 hours[Baseline, week 1, 4, 8, 12 and 16]