In short
Arnica montana mother tincture is a herbal preparation obtained from the Arnica montana plant. It is being studied in a Phase 3 clinical trial as a cream (ARTENSIUM®) for pain in knee osteoarthritis, a chronic joint disease. The trial compares the cream against a placebo in 200 adults over 14 days of treatment.
Key points
- Phase 3 trial of ARTENSIUM® cream in knee osteoarthritis pain
- 200 adults with symptomatic knee osteoarthritis are enrolled
- Applied to the skin (cutaneous use) for 14 days
- Primary measure: change in the KOOS Pain subscale score at Day 14
- Trial status: Authorised in the EU Clinical Trials Information System
What is arnica montana mother tincture?
Arnica montana mother tincture is a herbal preparation obtained from the Arnica montana plant. The mother tincture is a concentrated liquid extract made by macerating the fresh or dried plant parts in alcohol. In the clinical trial described here, the substance is formulated as a cream called ARTENSIUM® for application to the skin. The trial record lists the pharmaceutical form as a cream for cutaneous use.
How does arnica montana mother tincture work?
The trial record does not describe a specific molecular target or mechanism of action for arnica montana mother tincture. The study aims to evaluate whether the cream has a specific therapeutic effect on pain in patients with symptomatic knee osteoarthritis compared with placebo. The design compares the active cream against a placebo cream identical in appearance but without active substances, which allows any difference in pain scores to be attributed to the Arnica preparation itself.
Which conditions is it used or studied for?
- Knee osteoarthritis — a chronic degenerative joint disease in which the articular cartilage progressively deteriorates and the whole joint undergoes structural changes. People with this condition commonly experience knee pain, stiffness, reduced physical function and impaired quality of life.
How is arnica montana mother tincture given?
In the clinical trial, arnica montana mother tincture is given as ARTENSIUM® cream applied to the skin (cutaneous use). The trial record describes the pharmaceutical form as a cream. The treatment period under evaluation is 14 days, with assessments at Day 7 and Day 14.
What do the clinical trials show?
One clinical trial of arnica montana mother tincture in knee osteoarthritis is registered in the EU Clinical Trials Information System. It is a Phase 3, interventional study with 200 enrolled participants. The trial is currently authorised.
The study focuses on adults with symptomatic knee osteoarthritis who have knee pain requiring therapeutic management. Participants are treated with either ARTENSIUM® cream or a placebo cream that looks identical but contains no active substances.
The primary measure is the change in the KOOS Pain subscale score, which is a patient-reported questionnaire that assesses knee pain. The score is recorded at Day 0, Day 7 and Day 14, with the main estimate of the treatment effect taken at Day 14. If a person has pain in both knees, only the more painful knee is assessed.
The trial has not yet reported results, so the effect of the cream on pain scores is not yet known from this study.
What side effects are known?
The trial record does not provide information on side effects of arnica montana mother tincture or ARTENSIUM® cream. No supplementary sources on side effects were available for this page.