None listed
Conditions
Brief summary
This study is a 12-week, randomised, double-blind, placebo controlled, clinical trial to assess the effectiveness and safety of a novel herbal formulation, consisting of Curcuma longa (Turmeric), Boswellia serrata (Indian Frankincense) and Zingiber officinale (Ginger) for the management of osteoarthritis of the knee. The study will assess if taking this formulation helps reduce knee pain and improves function and wellbeing from osteoarthritis of the knee. It is expected that the herbal formulation will reduce pain from osteoarthritis of the knee over the course of 12 weeks compared to placebo medication.
Interventions
A standardised herbal formulation consisiting of Curcuma longa (Turmeric), Boswellia serrata (Indian frankincense) and Zingiber officinale (Ginger). Total active ingredients 300mg/tablet. 2 tablets morning and evening for the first 4 weeks, than 1 tablet morning and evening for the remaining 8 weeks of the trial.
Participants will receive 1 bottle at baseline which will contain 115 tablets for the 1st 4 weeks, with additional for compliance check. At 4 weeks participants will return any unused
A standardised herbal formulation consisiting of Curcuma longa (Turmeric), Boswellia serrata (Indian frankincense) and Zingiber officinale (Ginger). Total active ingredients 300mg/tablet. 2 tablets morning and evening for the first 4 weeks, than 1 tablet morning and evening for the remaining 8 weeks of the trial. Participants will receive 1 bottle at baseline which will contain 115 tablets for the 1st 4 weeks, with additional for compliance check. At 4 weeks participants will return any unused medication for compliance checks. They will be given the 2nd bottle of 115 tablets for the remaining 8 weeks, which will be return at week 12 for compliance check. The labels on the bottles 1 and 2 will be specific with dosage instructions for the 4 week period and 8 week period respectively. Participants will also fill out a diary daily recording the medication taken morning and night.
Sponsors
NICM Health Research Institute, Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
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
Outcome results
None listed