Condition category
Musculoskeletal Diseases
Date applied
21/02/2005
Date assigned
07/03/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jayesh Chaudhary

ORCID ID

Contact details

118
Morya House
Off Link Road
Anheri-west
Mumbai
4000 053
India
+91 (0)22 267 33092
vedic@ayuherbal.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3062/RF

Study information

Scientific title

Acronym

HerbomineralOA

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Mineral supplement (SierraSil), herbomineral supplement (SierraSil, cat's claw extract and vincaria)

Primary outcome measures

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 trial start date

01/09/2004

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

107

Participant 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

Recruitment start date

01/09/2004

Recruitment end date

01/01/2005

Locations

Countries of recruitment

India

Trial participating centre

118, Morya House
Mumbai
4000 053
India

Sponsor information

Organisation

Vedic Lifesciences (India)

Sponsor details

118
Morya House
Off Link Road
Andheri-west
Mumbai
4000 053
India
+91 (0)22 267 33092
vedic@ayuherbal.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Sierra Mountain Minerals, Inc. (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16242032

Publication citations

  1. Results

    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 [ISRCTN38432711]., J Inflamm (Lond), 2005, 2, 11, doi: 10.1186/1476-9255-2-11.

Additional files

Editorial Notes