Health Condition 1: null- Osteoarthritis Health Condition 2: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Boswellin tablet containing 3-O-Acetyl-11-keto-β-Boswellic acid: Two tablets of Boswellin to be taken orally along with the standard treatment for 120 days
Control Intervention1: Place
Sponsors
Sami labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either sex 35 to 75 years of age 2 Diagnosis of OA knees based on typical history, clinical presentation, classical radiological findings and fulfilling the ACR classification for OA knees i Crepitus + and morning stiffness greater than 30 min and bony enlargement + or ii Crepitus + and morning stiffness less than equal to 30 min or iii Crepitus - and bony enlargement + 3 A minimum pain VAS > 4 on walking in one or both knees during the 24 hours preceding recruitment 4 Patient ambulant and requiring treatment with an anti-inflammatory drug and not receiving regular anti inflammatory or analgesic drugs or are not satisfied with drugs being taken and seek a change 5 Willing to come for regular folloe-up visits 6 Able to give written informed consent
Exclusion criteria
Exclusion criteria: 1 Known history of hypersensitivity to herbal extracts or dietary supplements. 2 Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test 3 Non degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of OA (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection) 4 Patients incapacitated or bound to wheel chair or bed and unable to carry out self care activities 5 Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study. 6 Pre existing or recent onset of demylenating disorders or type I diabetes 7 Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine 8 Evidence of several renal, hepatic or hemopoitic disease or severe cardiac insufficiency as revealed by laboratory investigations 9 Patient with congestive heart failure 10 Patients with hypertension 11 Clinically significant untreated hyperlipidemia in context of a cardiovascular risk 12 History of having received any investigataional drug or participated in any other clinical trial which ended in preceding month or currently ongoing. 13 Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months 14 Non-co-operative attitude of the patient 15 Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Laboratory analysis 2. Sum of the function, pain, and stiffness sub-scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 3. Distance walked in 6 minutes to be measured 4. European Q5D Quality of Life 5. Radiological examination of X-ray Timepoint: 1. Laboratory analysis(Screening & Day 120) 2. WOMAC Questionnaire(Day 0, Day 30, Day 60, Day 90 and Day 120) 3. 6 minutes Walk Test(Day 0, Day 30, Day 60, Day 90 and Day 120) 4. European Q5D QOL(Day 0, Day 30, Day 60 , Day 90 and Day 120) 5. X-ray (Day 0 and Day 120) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. VAS Pain Scale 2. Physicians Global AssessmentTimepoint: 1. VAS Pain Scale(Day 0,Day 30,Day 60,Day 90 and Day 120) 2. Physicians Global Assessment(Day 0, Day 30,Day 60,Day 90 and Day 120) | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
ClinWorld(P)Ltd.
Outcome results
None listed