Clinical study to assess effectiveness and safety of ayurvedic products ostikot tablet, rhukot plus cream and rhukot liniment in patients with osteo arthritis of knee
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2015/02/005489
- Lead Sponsor
- Clinfound Clinical Research Services PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
1.Diagnosed with idiopathic KOA according to the clinical guidelines of the American College of Rheumatology. The guidelines include patients currently experiencing pain in one or both knees with at least 3 of the following 6 conditions: 1) aged 50 to 70 years, 2) morning stiffness within 30 minutes of waking, 3) crepitus, 4) bony tenderness, 5) bony enlargement, and 6) no palpable warmth.
2.VAS score during the most painful knee movement between 40-70 mm
3.Lequesneâ??s functional index score between 6-10 points
4.Patients ready to give written informed consent and willing to comply the study protocol
1.Inflammatory diseases, including rheumatoid arthritis
2.Cancer
3.Traumatic injury that might be related to the current knee pain
4.Autoimmune disease
5.Uncontrolled hypertension
6.Diabetes mellitus requiring insulin injection
7.Life-threatening cardiovascular or neurological events within the past year
8.Pregnant and lactating women
9.Chronic respiratory disease
10.Hemorrhagic disorder
11.Alcohol or drug addiction
12.Active infectious disease, including tuberculosis
13.Significant knee joint deformity
14.Knee replacement surgery for the affected knee
15.Knee arthroscopy within the past 2 years
16.Steroid injection in the knee joints within the past 3 months
17.Viscosupplement injections in the knee joints within the past 6 months
18.Joint fluid injection within the past 6 months
19.Acupuncture, Ayurvedic Therapy, or herbal medicine within the past 4 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome with respect to the effectiveness on KOA will be the mean change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) from baseline to 12 weeks.Timepoint: Baseline week 2 week 4 week 6 week 8 week 10 week 12
- Secondary Outcome Measures
Name Time Method 1.Change in VAS From Baseline to End of Treatment <br/ ><br>2.Change in LFI from Baseline to End of Treatment <br/ ><br>3.Changes in ESR From Baseline to End of TreatmentTimepoint: Baseline week 2 week 4 week 6 week 8 week 10 week 12