Translation Summary of Elements of Krallendorn Information
for Doctors and Pharmacists

(NOTE: Krallendorn is the German product name of a standardized extract of uncaria tomentosa. A patent exists in Germany for the production method. Pentacyclic oxindolalkaloids are the active constituents.)

Acute Toxicology (Huntington Research Center)

- Using a one-time oral dose of water extract of uncaria tomentosa in the amount of 16 grams herb per kilogram body weight of the test animals, 20% of the animals died (both male and female). The maximum volume administered was 40ml/kg body weight. The animals that died were observed to suffer hemorrhaging of the GI tract, which may have been the result of the high concentration (40%) coupled with the large volume administered. The surviving animals recovered fully. Because of the enormous amounts given this experiment is thought to have scarcely any relevance to the therapeutic use of uncaria.

- Another experiment tested on mice the use of oral and intraperitoneal administration of extract as well as the alkaloid fraction. The oral dose of the alkaloid fraction was 2g/kg body weight and intraperitoneally 1g/kg body weight. The extract was tested at the level of 5g/kg body weight for oral administration and 2g/kg parenterally. The animals were observed for 14 days and no deviation from the normal behavior was observed.

Conclusion: One-time oral administration of uncaria tomentosa extract in animal experiments is for all practical purposes atoxic. Death in one in five animals occurred when the amount administered reached the level of 16g/kg body weight. Intraperitoneal administration of the extract in the dosage of 2g/kg body weight was atoxic, as was administration of the alkaloid fraction in the dosage of 1g/kg body weight.

- A 28 day study tested daily oral administration of uncaria tomentosa extract in the amount of 1g/kg body weight. There was a control and study group of 10 male and female rats. The following areas were tested: use of feed, weight development and hematology, including differential blood analysis, thromboplastin time, as well as creatinin and alaninaminotransferase blood levels. Additionally, the rats were observed for changes in behavior and signs of disease. At the conclusion of the experiment the organs of the animals were weighed and examined.

Results: None of the parameters showed deviation from norms. There were no deaths. Weight development and use of feed was the same in control and test groups. The hematological parameters showed no deviation with the exception of the lymphocytes and granulocytes. In the study group the lymphocytes were slightly, but nonetheless statistically significantly, higher, while the percentage of neutrophile granulocytes were lower than in the control group. All values, though, were within norm. Phagocyte activity was slightly higher in the study group, and males in both groups showed higher levels of phagocyte activity than the females. Creatinin and alaninaminotransferase were unchanged. The color of the kidneys of four males was slightly lighter. This was observed of the females in control and study groups. There was no difference in the absolute weight of the organs. In relative weight comparisons, however, the kidneys of the study group had slightly higher values. Histologically, though, there was nothing noteworthy.

Conclusion: Daily administration of extract in rats is atoxic when taken in the amount of 1g/kg body weight over a period of 28 days.

Indications

Krallendorn should be employed as a monotherapy or in combination with other therapies in the following indications:

- diseases of a primarily inflammatory nature, especially of the rheumatic type.

- diseases resulting primarily from a misfunctioning of the immune system

- diseases resulting primarily from viral infections (acute & chronic)

- in the treatment of tumors as an adjunct to classical therapy (i.e. chemo- and radiation therapies) or as follow-up to those therapies

- allergies such as hayfever and allergic asthma

- many autoimmune diseases, especially neurodermatitis

Contraindications

- pregnant and nursing women -- not because of any data to indicate a danger here but simply to be safe until investigations can be made

- children under 3 -- same as rationale given above for pregnant women

- do not use in cases of leukemia when a bone marrow transplant is planned (at least one year should elapse from point of discontinued herb use to the transplant operation)

- do not use if any organ transplant is planned (see above for duration)

- absolutely contraindicated in cases of (deliberate) iatrogenically caused immune suppression

Side Effects

- in cases of autoimmune diseases or tumors, up to 2 weeks of constipation or diarrhea can result -- these conditions should be treated with appropriate remedies

- also in these cases a latent fever can erupt for up to 2 weeks

Use with other Medications

- stop use 2 days before chemotherapy and wait until 2 days after treatment before resuming

- because of its strong immunomodulating effects it should not be used with therapies that employ foreign proteins (i.e. passive immunizations, thymus, hormone therapies using animal proteins). No problems have been observed in these cases, but the occurrence of a serum reaction is conceivable. There is no problem with its use with active immunizations.

- a combination with hyperimmunoglobulin therapy should be avoided

Preparation of the Tea

Heat 20g of ground uncaria tomentosa root with 1 liter water for 45 minutes a 80 Celsius. Let cool 10 minutes. Filter through paper filter and bring water level back to 1 liter. Store in tightly sealed bottle at 2-8 Celsius.

- adult dose is 60 ml tea in 60 ml hot water on empty stomach in the morning

- dose for children 3-6 is 20ml tea in 20ml hot water also in morning

- dose for children 7-9 is 30 ml tea in 30 ml hot water also in the morning

- dose for children 10-12 is 50ml tea in 50ml hot water in morning

- children over 12 use the adult dose