Osteoarthrosis of the knee and hip. - Clinical symptoms due to osteoarthrosis of the knee and hip consisting of pain, stiffness and functional restriction.
Conditions
Interventions
Product Name: chinese herbal teas
Pharmaceutical Form: Herbal tea
Pharmaceutical form of the placebo: Herbal tea
Route of administration of the placebo: Oral use
Sponsors
Donau-universität Krems
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age: 45-70years - validated diagnosis of osteoarthrosis of knee or hip - result of 30-75mm in VAS in first screening - result of 30-75mm im Global WOMAC score in entry- examination - compliance for procedure of ingesting herbal decoctions and blood-testing. - everday mobility, patient should be able to walk. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - operations in the affected joint - arthroscopic interventions in the affectec joint one year before the start of trial - intraarticular injektion of cortisone or systemic application of cortisone during 8 weeks before start of trial. - inflammatory rheumatic disease of joint, ESR > 40mm/h - Hip pain, which is due to congenital joint dysplasia - patients with grave systemic diseases as Carcinoma, multiple sclerosis, with strong immunosupressive drug intake or chemotherapy. - congenital coagulation disorders - intake of strong anticoagulants like warfarin a.o. ( chinese herbal remedies can interact in some cases) - diagnosis of a grave psychiatric disease with intake of neuroleptics or lithium, and the necessity of regular psychiatric care. - GI bleeding during the last 8 weeks before begin of trial ( with the exception of mild hemorrhoidal bleeding) - chronic anemia ( hemoglobin 8 - Body -mass index > 30 - pregnancy, nursing; before admission to trial fertile women are obligated to a pregnancy test and a gynacologal examination; this has to be repeated once per month till the end of the trial. An effective contraception has to take place. - known allergies against any plant, which is used - if negative compliance is to be expected. - if there is considerable experience with chinese medicinal drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study of the effectiveness of treatment with chinese herbal remedies in form of decoction prescribed according to the diagnostic paradigma of traditional chinese medicine. Primary scientific question: is there a difference in the efficacy of herbal remedies in the osteoarthrosis of knee and hip wether they are prescribed according to the diagnostic rules of traditional chinese medicine or in a more or less by chance way of prescription? Null hypothesis: there is no difference in efficacy of herbal prescriptions, no matter if diagnostic aspects according to TCM underly the their prescription or not. ;Secondary Objective: -Observations concerning the therapeutic spectrum of the employed herbal remedies. -Questions concerning the safety and digestibility of the employed herbal remedies. -Questions of how general life quality is influenced by this kind of regime ( life quality is also a secondary evaluation parameter);Primary end point(s): Global WOMAC Score (Western Ontario and McMasters University) after 18 Weeks. | — |
Countries
Austria
Outcome results
None listed