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

Completed

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

Registration Number: ISRCTN38432711

Lead Sponsor: Vedic Lifesciences (India)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 107

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Visual Analogue Score (VAS) for pain<br>2. Consumption of rescue medication (paracetamol)<br>3. Recovery (physician and patients' assessments)<br>4. Tolerability<br>5. Safety variables<br>6. Vitals (pulse rate, temperature, blood pressure, respiration rate) measured at baseline and weeks 1, 2, 4, 6 and 8<br>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.