Commonly Asked Questions
What is Cararthron?
Cararthron® is a herbal supplement for temporary arthritic and joint pain relief. It contains a blend of the plant extracts: Scutellaria baicalensis and Acacia catechu.
It does NOT contain any dairy, egg, gluten, lactose, nuts, sugar, wheat, yeast, artificial colouring, flavouring or preservatives.
Does Cararthron® require a prescription?
No, Cararthron® does not require a prescription. It is sold through retail pharmacies, behind the pharmacy counters, as well as online stores, such as cararthron.com.au/shop .
Is Cararthron® safe?
Cararthron®’s ingredients have been designated as GRAS (Generally Recognized As Safe) according to strict FDA (Food and Drug Administration) standards.
In clinical studies, the ingredients used have been shown to have side effects comparable to placebo. To date, the number of side effects reported by physicians and patients has been less than 0.2% – exceptionally low.
Furthermore, Cararthron®’s ingredients have been tested in animal toxicology studies at doses between 5 and 20 times the human equivalent amount. In these studies, no significant adverse events were reported and no changes were observed in histology, blood serology, cell numbers, liver enzymes or electrolyte levels. Finally, studies in Fischer 344 rats, those genetically sensitive to gastrointestinal effects such as bleeding caused by chronic use of NSAIDs, showed no changes in stomach mucosa with chronic dosing.
Is Cararthron® effective?
Cararthron®’s onset of action has been reported to be as little time as a few hours to 4-5 days after taking Cararthron® for mild to moderate osteoarthritis.
In clinical studies, the combination of ingredients has been shown to safely and effectively manage osteoarthritis through dietary means, including significantly improving osteoarthritis patients’ functional mobility.
Is Cararthron® effective in rheumatoid arthritis (RA)?
Cararthron®’s effectiveness in RA has not been researched or clinically tested. Additionally, the research to determine the distinctive nutritional requirements of RA patients to support Cararthron® as a medical food product for RA has not been completed. Therefore, Cararthron® is not promoted for RA, and any usage for RA would be solely at the individuals’ initiative.
Client testimonials regarding the treatment of RA have been positive.
Does Cararthron® contain a recognised class of ingredients?
Cararthron® contains a widely recognized class of polyphenol ingredients commonly referred to as flavonoids. These are natural compounds from plant-based food sources which are generally accepted to provide certain therapeutic benefits and are often found in many fruits, vegetables and nuts.
Is there clinical data supporting Cararthron®?
Yes, strong clinical and scientific data support Cararthron®’s constituent ingredients. In randomised placebo-controlled, double-blind, as well as open-label studies, the ingredients have been clinically shown to deliver significant improvements in WOMAC measures for patients with osteoarthritis of the hip and/or knee. All primary clinical endpoints – functional mobility, functional stiffness and functional joint discomfort – showed significant improvements.
The results of some studies have been submitted for publication. Additionally, one of the main components of Cararthron® has been used in prescription products in Japan that have received approvals from the Pharmaceutical and Food Safety Bureau (the Japanese equivalent to the FDA) for over 20 years.
How strong of an antioxidant is Cararthron®?
The ingredient combination used in Cararthron® is a very strong antioxidant. When compared to Vitamin C and Vitamin E in oxygen radical absorbance capacity (ORAC) assays, an assay designed to measure the ability to “soak” up reactive oxygen species (ROS, also known as oxygen free radicals), Cararthron®’s ingredient combination, flavocoxid, has a high ORAC value (~5,500).* This value is higher than the comparable ORAC value of Vitamin C (~5,000) and Vitamin E (~1,100).* Cararthron®’s antioxidant potency is even significantly higher than that of blueberries and grapes, well-known sources of antioxidants. In terms of the metabolic process associated with osteoarthritis, the ability of a product to absorb oxygen free radicals can be beneficial to cartilage.
*Data on file, Primus Pharmaceuticals, Inc.
Can the recommended dosage for Cararthron® be increased beyond 250mg BID?
Consuming more than 250 mg BID of Cararthron® should be only under your health practitioner’s directions. Animal studies have shown that consuming the equivalent of up to 20 times the recommended human use (500mg/day) did not produce adverse effects.
What side effects have been observed in clinical practice?
In the clinical trials, the side effect incidence rates for Cararthron® were comparable to or slightly higher than placebo. The reported adverse events for Cararthron® include hypertension, varicose veins, fluid in knee, and psoriasis. There were no reports of anyone experiencing gastrointestinal difficulties in a 90-day human clinical trial.
The most common side effects that patients report with Cararthron® are nausea, diarrhea and flatulence, which are often mild and do not usually require discontinued use of Cararthron®.
On-going safety data is collected through post-marketing surveillance for Cararthron®. Patient and physician reported side effects are tracked and followed up.
Which patients should not use Cararthron®?
Cararthron® is indicated for the nutritional management of the metabolic aspects of osteoarthritis. Cararthron® has not been investigated for use in the nutritional management of rheumatoid arthritis (RA), acute pain, or primary dysmenorrhea. There are no formal studies among the following patient groups: patients with a history of severe stomach ulcers, patients under the age of 18, and pregnant or lactating women. Clinical practice by health practitioners has shown that Cararthron® is well-tolerated by patients with a history of mild ulcer.
Have there been any drug interactions with Cararthron®?
Since the ingredients used in Cararthron® were first introduced in Puerto Rico in mid 2004, we have not received any health practitioner reports of adverse events due to drug interactions. The ingredients have been tested for potential drug interactions via Cytochrome P450 (CYP450) assays. The test results strongly suggest that flavocoxid would not be likely to inhibit the biotransformation of prescription drugs
Can Cararthron® be taken by patients taking a blood thinner such as coumadin?
In animal studies, ingredients used in Cararthron® had no effect on prothrombin (PT) times, no augmentation of aspirin or coumadin effects on PTT or PT and no effect on platelet aggregation when tested in platelet rich rabbit plasma.* In human clinical trials, no changes in PT or PTT over a 90-day period at either 250 or 500 mg per day was observed.* Nonetheless, we suggest that Cararthron® be used cautiously in patients taking anticoagulants or anti-platelet agents, that patients be advised to look for and promptly report any evidence of unusual bleeding or bruising. Appropriate laboratory studies should be monitored on a regular basis in patients taking Cararthron® with anticoagulants or anti-platelet agents.
* Data on file at Primus Pharmaceuticals, Inc.
How long does it take Cararthron® to begin to manage osteoarthritis via nutritional management?
Cararthron®’s onset of action varies according to the severity of osteoarthritis. In clinical practice, health practitioners find that patients with mild to moderate osteoarthritis feel an onset of action in as little time as several hours to 4-5 days after taking Cararthron®. Moderate to severe osteoarthritis patients may feel onset of action in 5-10 days.
Should Cararthron® be taken with or without other foods?
Cararthron® is safe taken with or without other foods. Taking Cararthron® one hour before or after meals helps increase the absorption of Cararthron®’s key ingredients into the blood by 10-15% (data on file). This observation is based upon a pharmacokinetic study in humans, as well as in-market clinical experience in analysing physician and patient product reports. However, if indigestion is experienced, then we recommend taking Cararthron® with food.
Who are Chalmers Dale, the manufacturers of Cararthron®?
Chalmers Dale is a privately owned Australian company based in Milsons Point, Sydney, and a supplier of Health and Nutritional products to Australia and the world. Our company has a reputation for producing the highest quality products and providing the finest level of customer service.
The flexibility and the combination of our developmental expertise, coupled with the highest quality assurance – meeting the most stringent regulatory requirements of GMP and TGA, places us at the forefront of the global health and nutrition market.