Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: CISSUSLEAN?: Dose: 500mg
Dosage form: Capsules
Frequency: Once daily after dinner
Route of administration: Oral
Duration:84 days
Control Intervention1: Placebo: Dose: 500mg
Dosage
Sponsors
Star Hi Herbs Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants between 40 to 75 years 2. Suffering from unilateral or bilateral OA of the knee within grade 2 according to the Kellgren Lawrence Classification of Osteoarthritis 3. Patients with a minimum pain visual analogue scale (VAS) score 3.5 to 7.4. 4. The Western Ontario McMaster Index (WOMAC) score should be less than 48 5. Participants had to be able to walk and give both verbal and written information regarding the study 6. Subjects willing to comply with the prescribed treatment regime for the duration of study participation.
Exclusion criteria
Exclusion criteria: 1. Expectations for surgery in the near future 2. Patients who are on medication for OA 3. Known hypersensitivity to herbal extracts or dietary supplements 4. Pregnant or lactating women and women of childbearing potential not following adequate contraceptive measures or women who were found positive for urine pregnancy test 5. Non degenerative joint diseases or other joint degenerative diseases 6. Incapacitated or bound to a wheelchair or bed and unable to carry out self care activities 7. Current or recent (in the last 3 months) oral or intra articular corticosteroid therapy 8. Pre-existing or recent onset of demyelinating disorders or type I diabetes 9. Ongoing with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine 10. Renal, hepatic, hematopoietic disease, hypertension, severe cardiac insufficiency, congestive heart failure, and untreated hyperlipidemia (cardiovascular risk) 11. Ayurvedic formulation or any form of complementary alternative medicine therapy in the preceding 2 months 12. Receiving any investigational drug or participating in any other clinical trial that ended in preceding month or currently ongoing 13. Patients who needed high dose of NSAIDs or analgesics 14. Inability to comply with study procedures 15. Alcoholics and highly dependent persons (more than 3 days per week) 16. A person who is deemed inappropriate for this test by the project director
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: WOMAC VAS Timepoint: Screening Visit, Day 42 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Inflammatory Marker Levels 2. ESR 3. hs-CRP, 4. IL-6, 5. SerumLeukotrieneB4, 6. Serum MMP-3 Timepoint: Screening Visit, & Day 84;7. Vital signs 8. Hematological, blood biochemistry & urine analysis 9. Adverse drug reactions Other Assessments: 10. Dietary Record(Day 1, & day 84) 11. Physical Activity Assessment(Day 1, & day 84) Timepoint: Screening Visit & Day 84 | — |
Countries
India
Contacts
Public ContactDr C T SADASHIVA
Star Hi Herbs Pvt Ltd
Outcome results
None listed