Clinical Support
SierraSil® Clinical Studies
SierraSil® has been subjected to two rigorous clinical studies and a mechanism of action study, which demonstrate that SierraSil® is effective in reducing joint pain and discomfort associated with osteoarthritis within 2 weeks of treatment. Both of the clinical studies measured SierraSil®'s effects on joint pain, stiffness and physical function and mobility were assessed using the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, a disease-specific self-administered health status measure that is clinically accepted as reflecting osteoarthritis disease activity. From these extensive scientific assessments, experts agree that SierraSil® is safe and effective in rapidly relieving joint stiffness, pain and discomfort, while also promoting healthy joint function. The details of these exciting studies are described below.
1. Human Pilot Study
In a 10 person pilot study, patients with moderate osteoarthritis of the knee were randomly divided into two groups – one group taking SierraSil® alone and the other taking SierraSil® plus Vincaria®, a cat’s claw extract. The total daily dosage of SierraSil® in this study was 3 capsules/day (2 g), and patients were not allowed to use rescue medications such as ibuprofen or aspirin. Baseline WOMAC scores were used as the primary efficacy variable. The capsules were taken for 10 days and post-therapy WOMAC scores and any side effects were noted. 100% of the patients in this pilot study reported significant improvements in their symptoms within 1 week of treatment, without side effects.
2. Internationally Registered Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
In a internationally registered, multi-centered, randomized, double blind human clinical trial published in the Journal of Inflammation, over 100 patients with mild to moderate osteoarthritis took either low-dose (2 g), high-dose (3 g), low-dose SierraSil® with cat’s claw extract or placebo. The primary efficacy variable of the study was the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index. The research showed that the beneficial effects of SierraSil® on joint function and mobility were greater in the SierraSil® treated groups compared to placebo. The therapeutic effects of SierraSil® were rapid with no side effects, and statistically significant benefits were noted within one week of treatment.
Reference:
Miller MJ, Mehta K, Kunte S, Raut V, Gala J, Dhumale R, Shukla A, Tupalli H, Parikh H, Bobrowski P, Chaudhary J. Early relief of osteoarthritis symptoms with a natural mineral supplement and a herbomineral combination: a randomized controlled trial. J Inflamm (Lond). 2005 Oct 21;2:11.
3. Mechanism of Action Study
The positive results of the clinical studies on SierraSil® are further supported by a mechanism of action study, published in the Journal of the American Nutraceutical Association (JANA). This study on human knee cartilage showed that SierraSil® prevented cartilage breakdown by 68 - 73% in vitro. The results of this study suggest that SierraSil® may affect transcriptional events, which is shown by the reduced production of nitric oxide in response to a specific inflammatory compound that promotes cartilage breakdown in the joints (cytokine IL-1B). Inhibitors of nitric oxide production, such as SierraSil, are clinically recognized to benefit numerous inflammatory diseases including arthritis. This study demonstrates the mechanism of action for the beneficial effects on joint health and function seen in the clinical trials.
Reference:
Miller MJ, Ahmed S, Bobrowski P, Haqqi T. Suppression of Human Cartilage Degradation and Chondrocyte Activation by a Unique Mineral Supplement (SierraSil®) and a Cat’s Claw Extract, Vincaria®. JANA 2004; 7(2): 32-39.
SierraSil® Safety Research
SierraSil Health Inc. is committed to providing only the most safe and effective product to our customers. Therefore, in addition to the safety testing inherent in the clinical studies performed on SierraSil®, several other safety studies and tests have been carried out to demonstrate the safety of SierraSil®. These tests include the following toxicity and bioaccessiblity tests, which together provide sound evidence of the safety of SierraSil®.
1. Sub-Acute Oral Toxicity Study
In this study, a pharmaceutical industry standard 90-day SAOT study on 60 rats at 3 dosage levels, the highest being 35 times the Recommended Intake Level (RIL), found SierraSil® safe. An exhaustive and thorough examination of animal organs found no evidence of accumulation of any heavy metals or any toxic effects due to SierraSil®. Based on the findings of this study, the no-observed-adverse-effect-level (NOAEL) of SierraSil® in Sprague Dawley rats, following oral administration for 90 days was found to be more than 2,000 mg/kg body weight, the maximum dosage tested.
2. Bioaccessibility Testing
Pharmaceutical standard bioaccessibility testing was carried out on SierraSil® to confirm that the levels of individual minerals in SierraSil® are within safe recommended intake limits. The results show that only minute quantities of many minerals in SierraSil® are made available for absorption by the body, indicating not only that SierraSil® is very safe for consumption but also suggests an additive effect between the minerals and with the clay mineral structure to elicit the beneficial effects. Please refer to the Element Mineral Table attachment for details on the mineral content of SierraSil® and the Bioaccessibility Test Results.
3. Medical Analysis
A small medical analysis was performed on 10 patients to evaluate their general chemistry and hematology after taking a recommended dosage of SierraSil®. The results showed no adverse effects on chemistry or hematological parameters in these patients. Furthermore, it was determined that SierraSil® has beneficial effects on C Reactive Protein (CRP), a key compound in the inflammatory process.
