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
Protocol serial number	3062/RF
Sponsor	Vedic Lifesciences (India)
Funder	Sierra Mountain Minerals, Inc. (Canada)

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

118, Morya House
Off Link Road
Anheri-west
Mumbai
4000 053
India

Phone	+91 (0)22 267 33092
Email	vedic@ayuherbal.com

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, placebo-controlled multicentre trial
Secondary study design	Randomised controlled trial
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(s)	Western Ontario McMaster Arthritis Index (WOMAC) A, B, C and total scores (scores are for pain, stiffness, function).
Key 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.
Completion date	01/01/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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