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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38432711

Enrollment

107

Registered

2005-03-07

Start date

2004-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis (OA) of the knee Musculoskeletal Diseases Osteoarthritis (OA)

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 (l

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Western Ontario McMaster Arthritis Index (WOMAC) A, B, C and total scores (scores are for pain, stiffness, function).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026