To evaluate the efficacy of Ayurveda interventions in knee osteoarthritis.
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2022/08/044826
- Lead Sponsor
- Central council for research in Ayurvedic Sciences CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Participants of age between 35 to 65 years of any sex, residing in Northeastern states of India.
2.Participants diagnosed with knee osteoarthritis if they are presenting knee pain and radiographic joint space narrowing and/or osteophyte(s) shown on a radiograph performed within the previous 6 months, and having one of the following findings ââ?¬â?? age > 50 years, or morning stiffness for <30 minutes and crepitus on active motion and osteophytes3.
3.Participants suffering from knee osteoarthritis since not more than 10 years.
4.Participants having an average pain intensity score between 3 to 8 on an 11- point (0-10, where 0 is no pain and 10 is the worst pain imaginable) Numeric rating scale (NRS), at the time of screening
5.Participants with no significant alterations in Hematological and biochemical analyses that contraindicate intervention or may affect the outcomes.
6.Participants willing to provide informed written consent regarding their participation in the study for 12 weeks.
1.Participants with Kellgren-Lawrence (KL score) grade > 3
2.Obesity with a body mass index >30 (calculated as mass in kg/height in m2), unable to walk without aids or non-ambulatory participants
3.Patients on oral or parenteral steroids or immune-suppressive agents, intra-articular injection of any drug during the previous 4 weeks from day of screening
4.History of Acute Trauma, or having Congenital or acquired diseases leading to significant knee deformities
5.Patients diagnosed as Rheumatoid arthritis, or inflammatory arthritis, or systemic lupus erythematosus, or polyarthralgia, or Crystal arthritis (gout or pseudo-gout), or Hemophilic arthropathy or osteoporosis, or any surgical or medical neurological conditions condition that severely limits subjectsââ?¬• functional ability, Neoplasia
6.Signs of infection or history of positive serology for HIV, hepatitis, or syphilis, Acute / subacute Infection : TB, Pyogenic septic arthritis, Fungal, Hansenââ?¬•s disease
7.Pregnant women, lactating mothers
8.Participation in another clinical trial within 30 days prior to inclusion in the study
9.Allergy or hypersensitivity to any of the study drug or any other conditions that may, according to medical criteria, discourage participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Any change in physical function, pain and stiffness reported by the participant through Western Ontario and McMaster Universities Arthritis Index (WOMAC) score in both groups after treatment of 12 weeks.Timepoint: Baseline, 28th day, 56th day and 84th day
- Secondary Outcome Measures
Name Time Method 1) Any change in Quality of life of the participants assessed through Knee injury and Osteoarthritis Outcome Score (KOOS) after treatment in both groups. <br/ ><br>2) Comparison of Treatment emergent adverse events in both the groups. <br/ ><br>3) Comparison of number of NSAID tablets taken orally as rescue medicines for pain management during the treatment period in both groups. <br/ ><br>4) Any change in hematological and biochemical parameters (Complete Blood Count, Liver Function Test, Serum creatinine and blood urea) after treatment in both groupsTimepoint: 1)Baseline, 28th day, 56th day and 84th day. <br/ ><br> <br/ ><br> <br/ ><br>4)At baseline and at 84th day