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Doubleblind, randomized, placebo controlled clinical trial to proof the efficacy of a comfrey extract in subjects with painfull gonarthrosis

Conditions
Painfull gonarthrosis
Registration Number
EUCTR2005-003144-65-DE
Lead Sponsor
Merck Selbstmedikation GmbH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
220
Inclusion Criteria

- Age 18 years and older
- Intensity of pain at least 40 mm of a 100 mm VAS (Cisual analog scale)
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

- Intake of steroids during the last 4 weeks before the start of the trial
- Intake of analgetica (besides Paracetamol up to 2 g = 4x 500 g daily)
- Intake of systemic and/or local antiphlogistica/antirheumatica before the start of the trial
- Severe systemic or organic diseases

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Proof of a significant therapeutic effect of Kytta-Salbe f compared to placebo.;Secondary Objective: ;Primary end point(s): Investigation of pain (in rest and in motion) by using VAS
Secondary Outcome Measures
NameTimeMethod
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