Safety, tolerability, and efficacy of a dry extract from nettle leaves (Hox alpha) vs. NSAIDs in self-treatment of inflammatory joint pain in osteoarthritis. A propensity score-matched analysis of depersonalized 3-month data from the German Pain e-Registry - "Sipharo"

Study identification

• EU PAS number:
  EUPAS1000000564
• Study ID:
  1000000564
• Official title and acronym:
  Safety, tolerability, and efficacy of a dry extract from nettle leaves (Hox alpha) vs. NSAIDs in self-treatment of inflammatory joint pain in osteoarthritis. A propensity score-matched analysis of depersonalized 3-month data from the German Pain e-Registry - "Sipharo"
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  SIPHARO is an exploratory, non-interventional, post-marketing, open-label, retrospective, parallel-group, flexible-dose, comparative 12-week two-cohort study using depersonalized data from the German Pain e-Registry to evaluate the safety, tolerability, and efficacy of the nettle leaf extract Hox alpha compared to pharmacy-only nonsteroidal anti-inflammatory drugs (NSAIDs) in the self-treatment of adult patients with inflammatory joint pain in the context of osteoarthritis.
• Study status:
  Finalised

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned: 28/06/2024

Actual: 28/06/2024

Study start date

Planned: 01/07/2024

Actual: 01/07/2024

Data analysis start date

Planned: 01/08/2024

Actual: 01/08/2024

Date of final study report

Planned: 17/12/2024

Actual: 17/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Strathmann GmbH & Co. KG, Langenhorner Chaussee 602, 22419 Hamburg, Germany

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable