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    Summary
    EudraCT Number:2005-003696-20
    Sponsor's Protocol Code Number:----------------------------
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2005-003696-20
    A.3Full title of the trial
    "TCM- Phythotherapie bei Osteoarthrose von Knie und Hüfte" (TCM-Phythotherapy in the Osteoarthrosis of the knee and hip)
    A.4.1Sponsor's protocol code number----------------------------
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDonau-universität Krems
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namechinese herbal teas
    D.3.4Pharmaceutical form Herbal tea
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboHerbal tea
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoarthrosis of the knee and hip. - Clinical symptoms due to osteoarthrosis of the knee and hip consisting of pain, stiffness and functional restriction.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    -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)
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Global WOMAC Score (Western Ontario and McMasters University) after 18 Weeks.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    use of herbal remedies according to diagnosis of traditional chinese medicine
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    A 12 month period is reckoned for intervention and evaluation(=last visit of the last trial subject after maximum of 12 months) Another 12 months for utilizing the accomplished data.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    patients are offered ongoing treatment with TCM herbal therapy and acupuncture after participation in the trial under significantly reduced charges or free of charge.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
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