Research

Early relief of osteoarthritis symptoms with a natural mineral supplement and a herbomineral combination: A randomized controlled trial [ISRCTN38432711]

Mark JS Miller¹ , Komal Mehta² , Sameer Kunte² , Vidyanand Raut³ , Jayesh Gala⁴ , Ramesh Dhumale⁵ , Anil Shukla² , Hemant Tupalli² , Himanshu Parikh² , Paul Bobrowski⁶ and Jayesh Chaudhary²

¹  Center for Cardiovascular Sciences, Albany Medical College, Albany, New York, USA

²  Vedic Lifesciences, Mumbai, India

³  Ashok Raut Orthopedic Hospital, Virarwest, India

⁴  Bhagwati Hospital, Mumbai, India

⁵  K.J. Somaiya Medical College & Hospital, Mumbai, India

⁶  Santerra Pharmaceuticals, LLC, Raleigh, North Carolina, USA

author email corresponding author email

Journal of Inflammation 2005, 2:11doi:10.1186/1476-9255-2-11

Published:	21 October 2005

Abstract

Background

This study was designed to determine if a natural mineral supplement, sierrasil, alone and in combination with a cat's claw extract (Uncaria guianensis), vincaria, has therapeutic potential in mild to moderate osteoarthritis of the knee.

Methods

Patients (n = 107) with mild to moderate osteoarthritis of the knee were randomly assigned to one of 4 groups; high dose sierrasil (3 g/day), low dose sierrasil (2 g/day), low dose sierrasil (2 g/day) + cat's claw extract (100 mg/day) or placebo, administered for 8 weeks. Treatment was double blinded. Primary efficacy variables were WOMAC scores (A, B, C and total). Visual analog score (VAS) for pain, consumption of rescue medication (paracetamol), and tolerability were secondary variables. Safety measures included vital signs and laboratory-based assays.

Results

Ninety-one of the 107 patients successfully completed the protocol. All four groups showed improvement in WOMAC and VAS scores after 8 weeks (p < 0.001), in all 3 groups receiving sierrasil the magnitude of benefits were greater vs. placebo (WOMAC Total 38–43% vs. 27%) but this was not statistically significant. In reference to baseline values sierrasil treated groups had a considerably faster onset of benefits. Placebo-treated individuals failed to show significant benefits at 4 weeks (11% reduction in total WOMAC). In contrast, after 1 or 2 weeks of therapy all the sierrasil groups displayed significant reductions in WOMAC scores (p < 0.05) and at week 4 displayed a 38–43% improvement. VAS was significantly improved at 4 weeks in all groups (p < 0.001) but was significantly greater in all sierrasil groups compared to placebo (p < 0.05). Rescue medication use was 28-23% lower in the herbomineral combination and high dose sierrasil groups although not statistically different from placebo (P = 0.101 and P = 0.193, respectively). Tolerability was good for all groups, no serious adverse events were noted and safety parameters remained unchanged.

Conclusion

The natural mineral supplement, sierrasil alone and in combination with a cat's claw extract, improved joint health and function within 1–2 weeks of treatment but significant benefits over placebo were not sustained, possibly due to rescue medication masking. Sierrasil may offer an alternative therapy in subjects with joint pain and dysfunction.