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11 February 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| 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 |
| 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 |
| vedic@ayuherbal.com | |
| Date applied | 21/02/2005 |
| Last edited | 18/02/2008 |
| Date ISRCTN assigned | 07/03/2005 |
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