- BRAND NAME:Traumaplant®
- DOSAGE FORM:Herbal ointment
- ACTIVE SUBSTANCE:Comfrey extract
- INDICATION:Bruises, sports injuries, muscle and joint pain, wound healing from accompanying abrasions
- PRODUCT STATUS:Drug approval:
Traumaplant® is approved or registered in the following countries:
Austria, Canada, Chile, Costa Rica, Czech Republic, Dom. Rep., Ecuador, El Salvador, Germany, Guatemala, Honduras, Israel, Kuwait, Netherlands, Nicaragua, Panama, Peru, Slovak Republic, Switzerland, United Arab Emirates, United States, Venezuela
- PATENT PROTECTION:EU patent protection for comfrey “Symphytum x uplandicum NYMAN” free of pyrrolizidine alkaloids*
*Pyrrolizidine alkaloids are below the detection limit
Further information on Traumaplant®:
Traumaplant® product benefits - USP
Traumaplant® – the herbal pain therapy for all purposes!
Highly concentrated – highly effective – free of pyrrolizidine alkaloids*
- The active ingredient of Traumaplant®, the Symphytum herb concentrate (comfrey concentrate), derives from a patented comfrey variety. The use of the standardised comfrey guarantees a constant quality of the medicinal plants.
- Because of the self-growing and the use of these specific comfrey cultivation, the Symphytum extract is free of pyrrolizidine alkaloids:*The pyrrolizidine alkaloids are below the detection limit
- Unlike competitor products, the active ingredient of comfrey in Traumaplant® only derives from the upper, visible parts of the fresh plant, i.e. from flowers, leaves and stems – and not from the root.
- Traumaplant®-cream is highly concentrated and contains – compared to all of the competition – the highest percentage of active ingredient, i.e. 100 g cream correspond to 25 g of the medicinal plant Symphytum and 10 g Symphytum concentrate. Consequently, given the absence of pyrrolizidine alkaloids, there is no dosage restriction.
- The active ingredient of Traumaplant®, the Symphytum concentrate, is produced according to a special manufacturing method. It is a full extract, i.e. a hydroalcoholic extract consisting of the pressed juice and an ethanol/water-containing extract.
- The galenic and skin-caring properties are superior to those of competitor products:
a) Traumaplant® is a white cream. Due to the root components in the extract, competitor creams are brown-beige in colour.
b) Traumaplant® has a nice, pleasant and fresh smell due to the rosemary oils. Many competitor products have a strong smell of comfrey.
c) Bei Traumaplant® guarantees excellent penetration of the skin. When the cream is rubbed in, it can be observedthat the emulsion breaks after 2-3 minutes and percutaneous absorption takes place immediately.
- Traumaplant® is the only percutaneous anti-trauma medication that can be used on wounds. Traumaplant® does not irritate or burn and, in particular, has a verified clinical wound-healing effect. No other anti-trauma medication has this advantage. This superiority of the product Traumaplant® applies not only to the herbal antitraumatic agents, but, in particular, to all diclofenac, salicyl and ketofenac creams. This makes Traumaplant® also superior to Voltaren.
- Traumaplant® has been the subject of many high-quality and comprehensive clinical studies, making it clearly superior to all other herbal antitraumatic agents and Kytta in particular. In total there are 9 publications and two more are expected shortly. The most important ones are the two existing clinical studies by Kucera et al., both of which were published and put together in ICTR format. One of them deals with ankle sprains, the other looks at myalgia (muscle/back pain). The third large study by Kucera “Wound healing compared with placebo” has been completed.
Traumaplant® Clinical Studies
Evidence-based therapy with Traumaplant®:
- Four of these studies are double-blind, randomised and controlled: Each study included up to 300 patients.
- All results are statistically significant and correspond to the current status of the internationally recognized study guidelines.
- Some of the study results (wound healing, use in children) show a real superiority over high-volume chemical and herbal competitors (e.g. Diclofenac).
- The scientific study material may be used by licensees both for registration and marketing purposes.
|Author||Indication||Duration of study||Therapeutical effect|
|KUCERA et al(2018)
|Tolerability and effectiveness in pediatric use with application on intact and on broken
|14 days||A total of 712 children (386 children with intact skin and 326 children with abrasions and superficial wounds) were openly treated with1-5 applications daily after presenting for blunt traumas and sports accidents.
No adverse events occurred in the group of children with intact skin, and one intolerability reaction (burning and reddening) was observed after application to broken skin.
This study confirms an excellent benefit-to-risk ratio for the application of comfrey herb cream in the treatment of blunt traumas and sports injuries in children with intact and with broken skin.
|UEBELHACK et al(2014)
|Muscle pain related to overload-induced muscle soreness||1-2 days per patient||Symptoms of muscle soreness were induced in 24 healthy persons by a standardised muscle overload of both upper arms under controlled conditions. In the evaluation of the responder rate a significant effect was observed for pain on pressure already after 30 and 120 minutes. An improvement of pain on movement was already shown in the comparison of groups after 15 minutes.|
|KUCERA et al(2012)||Acute and chronic back pain||8 -10 days||The efficacy and tolerability of a topical preparation with an active substance concentrate made from the aerial parts of medicinal comfrey (Symphytum x uplandicum NYMAN) was tested in 215 patients with acute or chronic myalgia of the upper and lower back.
Conclusion: Topical comfrey extract has a fast acting analgesic effect in myalgia of the back caused by chronic strain as well as acute blunt injury.
|BARNA et al(2012) *||Wound healing in children||7 -9 days||In this double-blind, randomized, parallel clinical trial in 108 children (3-12 years) with fresh superficial skin abrasions Traumaplantreduced the wound area to 50% approx. one day quicker than the reference product (1% Symphytum extract). Efficacy, excellent safety and tolerability of Traumaplant in the indication acceleration of wound healing in children could be demonstrated.|
|Schmidt et al (2011)||Children with acute, blunt traumata||7 days||The results of this non-interventional study regarding the tolerability and effectiveness of the medication are consistent with previously published clinical data in adults. 361 male and female children in the age of 4–12 years with acute blunt traumata (contusions, strains or distortions which occurred within the last 48 hours) were examined in 8 German centres in the years 2008 and 2010. This product, which combines anti-inflammatory and analgesic effects in a topical preparation, offers a safe and effective approach.|
|Guth, A(2009)||Functional disorders of the cervical vertebral column||3 weeks||In a study realized in two rehabilitation clinics with 255 patients having the cervical syndrome the test persons additionally applying Traumaplant®experienced a significantly or numerically more pronounced relaxation of contracted muscles (especially the trapezius muscle) as well an improved mobility of muscle fasciae.|
|Barna et al.(2007) *||Wound healing||10 days||Distinct wound healing effects can be attributed to Traumaplant as a result of a randomized, double-blind study with 278 patients. The results can explicitely also be made use for the administration of children. The product in a 10% dosage of active ingredient was tested against a reference cream containing 1% of active ingredient.|
|Kucera, M.(2005) *||Muscle pain (Myalgia)||10 days||In a double-blind randomised and controlled clinical trial with 218 patients the local efficacy and safety of Symphytum herb extract ointment 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|
|Kucera, M.(2004)*||Accidental and sports injuries (Ankle distortion)||14 days||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.|
|Kucera, M.(2000)||Muscular Symptoms and Functional Disturbances||14 days||In an open uncontrolled study, 105 patients with locomotor system symptoms were treated twice daily. A clear therapeutic effect was noted on chronic and subacute symptoms that were accompanied mainly by functional disturbances and pain in the musculature. The preparation was most effective against muscle pain, swelling and overstrain, arthralgia/distortions, enthesopathy and vertebral syndrome.|
|Mayer, G.(1993)||Acute Supraspinatus Tendon Syndrome (Painful shoulder)||21 days||Comparative study (30 patients during 3 weeks) between test group (Traumaplant® ) and control group (without the additional topical treatment): Significantly better efficacy of test group i.e. pain symptoms and correlated functional disturbances decreased considerably. The clinical criteria were day pain, night pain and “abduction-provoked painful arc”.|
|Mayer, G.(1992)||Contusions and Distortions of the Knee Joint||14 days||The local efficacy of a phyto-antitraumatic (an ointment containing a Symphytum active substance complex) was tested with acute contusions and distortions of the knee joint. Clinical symptoms (joint swelling, pain on active and passive movement, local rest pain) decreased rapidly and soon subsided. All 22 investigated patients were completely free of pain after 10 to 14 days or even earlier.|
|Hess, H.(1991)||Sports Injuries of the Knee Joint||8 days||Treatment with a Symphytum peregrinum ointment was carried out for an average of 8 days on 40 patients suffering from recent knee joint injuries, distortions and contusions which did not require surgery. 85% of the patients rated the efficacy of the preparation as good to very good in case of blunt sports injuries (Criteria for the therapeutical effect were pain, swelling and limitations of moving)|
|Mayer, G.(1991)||Acute lateral Distortions of the Ancle Joint||14 days||Significantly positive result with Traumaplant® compared with conventional cryotherapy. The clinical criteria of this controlled study are resting pain, pain on movement and swelling (Tested no. of patients: 28)|
|Niedner, R. (1989)||Open shallow wounds||5 days||Significant effect on the estimulation of epithelialization in the case of open shallow wounds with an intact columnar layer in healthy volunteers (10 patients). The ointment base and a polyacrylamide agar gel with active substances served as controls.|
Marketing examples Traumaplant®: