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A double blind randomised placebo controlled trial to compare two doses of a mineral supplement and a herbomineral combination in alleviating the symptoms of osteoarthritis of the knee
ISRCTN ISRCTN38432711
DOI 10.1186/ISRCTN38432711
ClinicalTrials.gov identifier
EudraCT number
Public title A double blind randomised placebo controlled trial to compare two doses of a mineral supplement and a herbomineral combination in alleviating the symptoms of osteoarthritis of the knee
Scientific title
Acronym HerbomineralOA
Serial number at source 3062/RF
Study hypothesis It was proposed that a natural mineral supplement, which has been shown to attenuate the degradation of human cartilage caused by the cytokine, interleukin-1 (IL-1), and catabolic pathways like nitric oxide production, would provide relief of the symptoms of osteoarthritis (OA) of the knee. The study examined two doses of this mineral supplement, as well as the combination of the low dose with a botanical extract, cat's claw, which had previously been reported to be effective in treating OA. These three groups were compared to a placebo treated group and treatment was for an 8 week period.
Lay summary
Ethics approval Ethics approval received from the Institutional Ethics Committee of K.J. Somaiya Medical College & Hospital, Mumbai (India) and was in compliance with the Helsinki Declaration.
Study design Randomised, double-blind, placebo-controlled multicentre trial
Countries of recruitment India
Disease/condition/study domain Osteoarthritis (OA) of the knee
Participants - inclusion criteria 1. Ambulatory adults of either sex of greater than 20 years of age
2. OA of the knee diagnosed as per radiologic examination and the American Rheumatology Association (ARA) functional classification (II or III) or Kellgren-Lawrence Classification of grade II or grade III
3. Functional assessments of overall pain of at least 50 mm on a 100 mm Visual Analogue Scale
Participants - exclusion criteria 1. Osteoarthritis of grade I or grade IV
2. ARA functional class I or IV
3. Any arthritis other than OA
4. Arthroscopy of either knee for the past year
5. Intraarticular steroids for the last 3 months or hyaluronic acid in the last 9 months
6. Pregnant or lactating women
7. Evidence of severe renal, haematologic disease or severe cardiac insufficiency as revealed by laboratory investigations and other tests
8. Unwilling to come to regular follow up visits for the duration of the study
9. Moderate to severe peripheral neuropathy
10. Any condition that the investigator feels does not allow participation in the study
Anticipated start date 01/09/2004
Anticipated end date 01/01/2005
Status of trial Completed
Patient information material
Target number of participants 107
Interventions Group A: Mineral supplement SierraSil (high dose 750 mg/capsule, 4 capsules a day)
Group B: Mineral supplement SierraSil (low dose 500 mg/capsule, 4 capsules a day)
Group C: Herbomineral supplement (low dose SierraSil 500 mg, 4 times a day, plus cat's claw extract, vincaria, 25 mg/capsule, 4 times a day)
Group D: Placebo (750 mg/capsule, 4 times a day)
Rescue Medication: Paracetamol
Primary outcome measure(s) Western Ontario McMaster Arthritis Index (WOMAC) A, B, C and total scores (scores are for pain, stiffness, function).
Secondary outcome measure(s) 1. Visual Analogue Score (VAS) for pain
2. Consumption of rescue medication (paracetamol)
3. Recovery (physician and patients' assessments)
4. Tolerability
5. Safety variables
6. Vitals (pulse rate, temperature, blood pressure, respiration rate) measured at baseline and weeks 1, 2, 4, 6 and 8
7. Laboratory investigations - complete blood count, serum glutamate pyruvate transaminase (SGPT), serum creatinine, erythrocyte sedimentation rate (ESR) at screening and week 8, adverse event monitoring at week 1, 2 4, 6, 8.
Sources of funding Sierra Mountain Minerals, Inc. (Canada)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/16242032
Contact name Mr  Jayesh  Chaudhary
  Address 118, Morya House
Off Link Road
Anheri-west
  City/town Mumbai
  Zip/Postcode 4000 053
  Country India
  Tel +91 (0)22 267 33092
  Fax +91 (0)22 56941179
  Email vedic@ayuherbal.com
Sponsor Vedic Lifesciences (India)
  Address 118, Morya House
Off Link Road
Andheri-west
  City/town Mumbai
  Zip/Postcode 4000 053
  Country India
  Tel +91 (0)22 267 33092
  Fax +91 (0)22 56941179
  Email vedic@ayuherbal.com
Date applied 21/02/2005
Last edited 18/02/2008
Date ISRCTN assigned 07/03/2005
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