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 | https://doi.org/10.1186/ISRCTN38432711 |
| Secondary identifying numbers | 3062/RF |
- Submission date
- 21/02/2005
- Registration date
- 07/03/2005
- Last edited
- 18/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Jayesh Chaudhary
Scientific
Scientific
118, Morya House
Off Link Road
Anheri-west
Mumbai
4000 053
India
| Phone | +91 (0)22 267 33092 |
|---|---|
| vedic@ayuherbal.com |
Study information
| Study design | Randomised, double-blind, placebo-controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HerbomineralOA |
| Study objectives | 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. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | Osteoarthritis (OA) of the knee |
| Intervention | 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 |
| Intervention type | Supplement |
| Primary outcome measure | Western Ontario McMaster Arthritis Index (WOMAC) A, B, C and total scores (scores are for pain, stiffness, function). |
| Secondary outcome measures | 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. |
| Overall study start date | 01/09/2004 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 107 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- India
Study participating centre
118, Morya House
Mumbai
4000 053
India
4000 053
India
Sponsor information
Vedic Lifesciences (India)
Industry
Industry
118, Morya House
Off Link Road
Andheri-west
Mumbai
4000 053
India
| Phone | +91 (0)22 267 33092 |
|---|---|
| vedic@ayuherbal.com | |
"ROR" |
https://ror.org/00xd7fg81 |
Funders
Funder type
Industry
Sierra Mountain Minerals, Inc. (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 21/10/2005 | Yes | No |
