In short
Harpagophytum procumbens mother tincture is a plant-based substance derived from devil's claw, a herb traditionally used for joint and muscle complaints. It is being studied in a Phase 3 clinical trial as ARTENSIUM® cream for adults with symptomatic knee osteoarthritis, a condition causing knee pain, stiffness and reduced physical function.
Key points
- Harpagophytum procumbens is a plant-derived substance, also known as devil's claw, used in a cream called ARTENSIUM® for knee osteoarthritis pain.
- One Phase 3 trial is authorised, with a planned enrolment of 200 adults with symptomatic knee osteoarthritis.
- The trial compares ARTENSIUM® cream against a placebo cream applied to the skin.
- The main measure is change in the KOOS Pain subscale score at Day 14, after 7 and 14 days of treatment.
- The study is interventional and currently has the status Authorised.
What is harpagophytum procumbens mother tincture?
Harpagophytum procumbens mother tincture is a plant-based preparation obtained from the roots of Harpagophytum procumbens, a plant commonly known as devil's claw. In the clinical trial described here, the substance is formulated as ARTENSIUM® cream, a product applied to the skin. The trial record lists the active substance as "Harpagophytum procumbens mother tincture" and the investigational product as ARTENSIUM, crème, for cutaneous use. The substance is being investigated for its effect on knee pain in adults with knee osteoarthritis, a chronic degenerative joint disease.
How does harpagophytum procumbens mother tincture work?
The clinical trial record does not describe the mechanism of action of harpagophytum procumbens mother tincture. The study is designed to evaluate the specific therapeutic effect of ARTENSIUM® cream compared with placebo on pain in patients with symptomatic knee osteoarthritis after 7 and 14 days of treatment. The trial measures change in pain using the KOOS Pain subscale score, a patient-reported measure of knee pain and related problems.
Which conditions is harpagophytum procumbens mother tincture studied for?
The registered clinical trial investigates harpagophytum procumbens mother tincture in one condition:
- Knee osteoarthritis — a chronic degenerative joint disease characterised by progressive deterioration of the articular cartilage and structural changes affecting the entire joint. Patients commonly experience knee pain, stiffness, reduced physical function and impaired quality of life. The study focuses on adults with symptomatic knee osteoarthritis experiencing knee pain requiring therapeutic management.
How is harpagophytum procumbens mother tincture given?
In the registered trial, harpagophytum procumbens mother tincture is given as ARTENSIUM® cream for cutaneous use, meaning it is applied to the skin. The trial record describes the dosage form as "3 DF dosage form" for cutaneous use. The study also includes a placebo cream that is identical in appearance to ARTENSIUM® cream but contains no active substances.
What do the clinical trials show?
One clinical trial of harpagophytum procumbens mother tincture is registered in the EU Clinical Trials Information System. The trial is a Phase 3, interventional study with a planned enrolment of 200 participants. Its status is Authorised, meaning the trial has received regulatory approval to proceed.
The study compares ARTENSIUM® cream against a placebo cream in adults with symptomatic knee osteoarthritis. The main outcome measure is the change in the KOOS Pain subscale score, assessed at Day 0, Day 7 and Day 14, with the primary estimate of treatment effect at Day 14. If a patient experiences pain in both knees, only the most painful knee is assessed.
The trial is designed to evaluate the specific therapeutic effect of ARTENSIUM® cream compared with placebo on pain after 7 and 14 days of treatment. No results are reported in the registry record at this time.
What side effects are known?
The clinical trial registry record does not provide information on side effects of harpagophytum procumbens mother tincture or ARTENSIUM® cream. No supplementary sources on side effects were available for this page.