Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Arthrohills Capsules: Arthrohills Capsules contains Vitex nigundo, Trigonella foenum-graecum, Zingiber officinale, Maharasnadi, Dashmooladi, Boswellia serrata, Smilax china, Balsamodend
Sponsors
Herbal Hills Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years 2. History of knee pain due to osteoarthritis requiring the use of NSAIDs, Acetaminophen, or another analgesic agent on a regular basis i.e. greater than or equal to three days per week for at least six months before the screening visit 3. OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria 4. Subjects with pain VAS greater than or equal to 40 mm on weight bearing activities
Exclusion criteria
Exclusion criteria: 1. Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease 2. History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit 3. Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study 4. Use of systemic corticosteroids within 2 months of screening, or intra-articular visco supplementation within the past 3 months 5. Subjects having diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease 6. Known other major medical or surgical disease 7. Pregnancy and Lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of Knee Joint Pain on VAS 2.Assessment of WOMAC Index Timepoint: Day -7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Quality of life on Karnofsky and Lansky Performance Score 2)Time to walk 50 feet and distance between feet while walking 50 feet on even surface. 3)Global assessment for overall improvement by the subject and Investigator at the end of study treatment. 4)Assessment of use of NSAIDs as rescue medicine 5)Tolerability of the study drug 6) Safety laboratory parametersTimepoint: Day -7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed