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Planta Med 2017; 83(18): 1384-1391
DOI: 10.1055/s-0043-112750
Biological and Pharmacological Activity
Original Papers
Georg Thieme Verlag KG Stuttgart · New York

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

Margret Moré
1   Herbalist & Doc Gesundheitsgesellschaft mbH, Berlin, Germany
,
Joerg Gruenwald
1   Herbalist & Doc Gesundheitsgesellschaft mbH, Berlin, Germany
,
Ute Pohl
2   analyze & realize GmbH Berlin, Germany
,
Ralf Uebelhack
3   Charité, Berlin, Germany
› Author Affiliations
Further Information

Publication History

received 04 January 2017
revised 06 May 2017

accepted 27 May 2017

Publication Date:
14 June 2017 (online)

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Abstract

The special formulation MA212 (Rosaxan) is composed of rosehip (Rosa canina L.) puree/juice concentrate, nettle (Urtica dioica L.) leaf extract, and devilʼs 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.

Key words

knee osteoarthritis - clinical trial - Rosa canina L. - Rosaceae - Urtica dioica L. - Urticaceae - Harpagophytum procumbens DC. ex Meisn./Harpagophytum zeyheri Decne. - Pedaliaceae - WOMAC

Supporting Information

    Fig. 1S (Supporting Information) shows HPLC chromatograms at 270 nm and 350 nm of the single MA212 ingredients (R. canina puree/juice concentrate, U. dioica leaf extract, H. procumbens/zeyheri root extract) and of Rosaxan; the positions of the marker compounds are indicated, and inlays show the UV spectra of the markers.

    Also, Table 1S (Supporting Information) shows characteristics of the ingredients of the special formulation MA212 (Rosaxan).

  • Supporting Information
 

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