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Planta Med. 2017 Dec;83(18):1384-1391. doi: 10.1055/s-0043-112750. Epub 2017 Jun 14.

A Rosa canina - Urtica dioica - Harpagophytum procumbens/zeyheri Combination Significantly Reduces Gonarthritis Symptoms in a Randomized, Placebo-Controlled Double-Blind Study.

Author information

1
Herbalist & Doc Gesundheitsgesellschaft mbH, Berlin, Germany.
2
analyze & realize GmbH Berlin, Germany.
3
Charité, Berlin, Germany.

Abstract

The special formulation MA212 (Rosaxan) is composed of rosehip (Rosa canina L.) puree/juice concentrate, nettle (Urtica dioica L.) leaf extract, and devil's claw (Harpagophytum procumbens DC. ex Meisn. or Harpagophytum zeyheri Decne.) root extract and also supplies vitamin D. It is a food for special medical purposes ([EU] No 609/2013) for the dietary management of pain in patients with gonarthritis.This 12-week randomized, placebo-controlled double-blind parallel-design study aimed to investigate the efficacy and safety of MA212 versus placebo in patients with gonarthritis.A 3D-HPLC-fingerprint (3-dimensional high pressure liquid chromatography fingerprint) of MA212 demonstrated the presence of its herbal ingredients. Ninety-two randomized patients consumed 40 mL of MA212 (n = 46) or placebo (n = 44) daily. The Western Ontario and McMaster Universities Arthritis Index (WOMAC), quality-of-life scores at 0, 6, and 12 weeks, and analgesic consumption were documented. Statistically, the initial WOMAC subscores/scores did not differ between groups. During the study, their means significantly improved in both groups. The mean pre-post change of the WOMAC pain score (primary endpoint) was 29.87 in the MA212 group and 10.23 in the placebo group. The group difference demonstrated a significant superiority in favor of MA212 (pU < 0.001; pt < 0.001). Group comparisons of all WOMAC subscores/scores at 6 and 12 weeks reached same significances. Compared to placebo, both physical and mental quality of life significantly improved with MA212. There was a trend towards reduced analgesics consumption with MA212, compared to placebo. In the final efficacy evaluation, physicians (pChi < 0.001) and patients (pChi < 0.001) rated MA212 superior to placebo. MA212 was well tolerated.This study demonstrates excellent efficacy for MA212 in gonarthritis patients.

PMID:
28614869
DOI:
10.1055/s-0043-112750
[Indexed for MEDLINE]

Conflict of interest statement

Conflict of Interest: Margret Moré, Ph.D. and Joerg Gruenwald, Ph.D. are affiliated with Herbalist & Doc Gesundheitsgesellschaft mbH (H&D), for which they planned, conducted, and scientifically evaluated this study. H&D is affiliated with MedAgil, who is the sponsor of this study. Ute Pohl and Prof. Dr. Ralf Uebelhack (also University Professor at the Charité) are affiliated with the CRO analyze & realize GmbH, which in turn was engaged by H&D to conduct the study.

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