Traumaplant^® Cream

The percutaneous antitraumatic

• for bruises and sprains, joint and muscle pain
• relieves pain, reduces swelling and inflammation
• additional wound healing, for open and blunt injuries
• highly concentrated active ingredient from
  medical comfrey (Trauma-Comfrey)

Composition

Symphytum concentrate	10.0 g
(ex herba symphyti recente	25.0 g)
Emulsion cream base	ad 100.0 g

The active components in Traumaplant^®
The active ingredients contained in Traumaplant^® cream are taken from freshly harvested symphytum blossoms and leaves, a specially cultivated medical comfrey (Symphytum x uplandicum NYMAN) -  “Trauma-Comfrey”. 

By means of a particulary careful process,
the pharmacologically active, high dosage and standardized ingredients in Traumaplant^® are isolated from the
freshly pressed plant sap.

Choline, rosmarinic acid derivates and allantoin provide the antiphlogistic, antiexudative and wound-healing effects.

In intermediary metabolism, choline is the central building block for various biosynthetic processes and achieves vasodilatation through the parasympathetic nerve endings and therefore, improves perfusion in the inflamed tissue.

Inflammatory exudates and metabolic products are removed. Acting as a vasoactive substance with capillary membrane-sealing properties, choline is the most important anti-exudative ingredient among the active components in Traumaplant^®.

Besides anti-exudative properties, rosmarinic acid derivates possesses an excellent antiphlogistic effect and inhibits the formation of inflammation mediators.

Allantoin - an active component in Traumaplant^® - stimulates cell proliferation and promotes regeneration of damaged tissue. It is, therefore, responsible for the effects which promote granulation and the wound-healing action of Traumaplant^® cream.

Traumaplant^® - the percutaneous antitraumatic
The various pharmacological properties
of the ingredients in Traumaplant^®

• antiphlogistic
• anti-exudative
• wound healing
• analgetic

are responsible for the extensive and reliable effects of this antitraumatic medication in cases of painful diseases of joints, sports injuries, sprains, bruises, slow-healing wounds and inflammatory symptoms associated with disorders of the muscles, tendons and joints.

The emulsion system of the cream base has been highly developed from both a galenical and cosmetic point of view.

Traumaplant^® acts directly on superficial wounds and, after percutaneous absorption, on deeper lying injuries - especially in cases of deeper inflammations and exudates resulting from blunt injuries.

Traumaplant^® provides topical treatment without systemic side effects.

Successful treatment using Traumaplant^® provides

• rapid decrease in swelling and inflammation
• pain relief
• reduces feeling of tension
• additional wound healing
  thus, Traumaplant^® is reliable and effective in cases of both open and blunt injuries.
  

Clinical Trials
with Traumaplant^®
- Information for Experts -

M. BARNA et al. ( 2007) University Hospital for Sports and Rehabilitation Medicine, 2nd Medical Faculty of the Karls University, Prague: Distinct wound healing effects can be attributed to Traumaplant as a result of a randomized, double-blind study with 278 patients. The product in a 10% dosage of active ingredient was tested against a reference cream containing 1% of active ingredient.

M. KUCERA et al. (2005) University Hospital for Sports and Rehabilitation Medicine, 2nd Medical Faculty of the Karls University, Prague: In a double-blind randomised and controlled clinical trial with 218 patients the local efficacy and safety of Symphytum herb extract cream 10% against 1% in the indication muscle pain – myalgia could be confirmed. Compared to reference product, the active treatment was clearly superior regarding the reduction of the primary criterion pain on active motion.

M. KUCERA et al. (2004) University Hospital for Sports and Rehabilitation Medicine, 2nd Medical Faculty of the Karls University, Prague: In a double-blind randomised clinical trial (203 patients) the efficacy, safety and tolerability as well as the excellent risk-benefit ratio of Traumaplant^® cream with accidental and sports injuries (ankle distortion) could be demonstrated.
M. KUCERA, (2000) University Hospital for Sports and Rehabilitation Medicine, 2nd Medical Faculty of the Karls University, Prague: In an open, uncontrolled study, 105 patients with locomotor system symptoms were treated with Traumaplant^®.
A clear effect was noted for all diseases in which the muscular component plays a role

G. MAYER (1993) tested Traumaplant^®
in a renewed comparative study of acute calcareous tendonitis syndrome (painful shoulder). The study criteria were day pain, night pain and painful arches by abduction. The study shows a definite superior effect
of Traumaplant^®cream with consistent cutaneous application compared to the control group.

Traumaplant^® also proved to be a very effective cream for the treatment of sport injuries of the knee joint – a major field of application of percutaneous medications -
as demonstrated in the study by H. HESS, Saarlouis Orthopedic Hospital (Germany, 1991). The therapeutic parameters includes pain, swelling and restriction of movement.
A total of 40 patients were examined in this study which verified the excellent tolerance
of the preparation and marked efficacy
of Traumaplant^® for blunt sport injuries.

The study report by G. MAYER confirmed
the findings of H. HESS that for the same indication, i.e. knee joint contusions and sprains, Traumaplant^® has a distinctly positive therapeutic effect on the acutely injured knee (MAYER 1992).

G. MAYER, University Hospital for Orthopedics, Greifswald (Germany), studied the antitraumatic and antiphlogistic effect of Traumaplant^® cream in the local treatment of acute lateral sprains compared to cryotherapy. Hereby, the positive effect achieved with Traumaplant^® was significantly superior to the comparative therapy (MAYER 1991).

R. NIEDNER, (1989) Dermatological University Hospital, Freiburg (Germany), confirmed the wound-healing action of Traumaplant^® cream in a controlled clinical- pharmacological trial. Traumaplant^® was thereby shown to exert a significant effect
on the stimulation of epithelialization of open,
flat wounds compared to the effect achieved with the emulsion cream base.

Indications:

Bruises and sprains (sports and accidental injuries), joint and muscle pain, slow healing wounds.

Application and Dosage:

For external applicaton. If not otherwise instructed, the cream should be applied
up to several times daily to the afflicted region. Especially suitable for cream bandages.

Contra-Indications:

No contra-indications are known.

Traumaplant® is free of problematic pyrrolicidine alcaloides (detection limit 0,1 ppm, officially fixed safety limit 10 mg pyrrolicidine alcaloides / day)

Side effects:

In rare cases erythema (reddening of the skin) may occur, especially in patients with extremely sensitive skin or with an allergic tendency to a component of Traumaplant^® cream.

Interaction with other drugs:

No interactions with other drugs are known.
Presentation:

Traumaplant® cream	25g
Traumaplant® cream	50 g
Traumaplant® cream	100g