TCM- Phythotherapie bei Osteoarthrose von Knie und Hüfte (TCM-Phythotherapy in the Osteoarthrosis of the knee and hip)

• Conditions: Osteoarthrosis of the knee and hip. - Clinical symptoms due to osteoarthrosis of the knee and hip consisting of pain, stiffness and functional restriction.

• Registration Number: EUCTR2005-003696-20-AT
• Lead Sponsor: Donau-universität Krems

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

- 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 < 12 in women, < 13 in men)
- chronic alcoholics
- pathological liver and kidney labarotory parameters
- liver and kidney disease in pat. history
- IDDM or NIDDM, if HbA1c > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified