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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: Product Name: chinese herbal teas Pharmaceutical Form: Herbal tea Pharmaceutical form of the placebo: Herbal tea Route of administration of the placebo: Oral use CONDITION: Osteoarthrosis of the knee and hip. ‐ Clinical symptoms due to osteoarthrosis of the knee and hip consisting of pain, stiffness and functional restriction. PRIMARY OUTCOME: 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.; ; Primary end point(s): Global WOMAC Score (Western Ontario and McMasters University) after 18 Weeks. 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) 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
Epistemonikos ID: 61fba4e1747b88f7dd7c4e79247a8f43dff7624c
First added on: Aug 21, 2024