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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003144-65-DE
Enrollment
220
Registered
2005-07-21
Start date
2005-10-17
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painfull gonarthrosis

Interventions

Trade Name: Kytta-Salbe f Product Name: Kytta-Salbe f Pharmaceutical Form: Ointment INN or Proposed INN: None (because of Extract) Concentration unit: g gram(s) Concentration number: 35-100 Pharmaceut

Sponsors

Merck Selbstmedikation GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026