Sponsor aimed to study hydroalcoholic extract of Andrographis paniculata (for its effect on OA disease progression in OA patients with moderate to severe knee OA. Hydroalcoholic extract of Andrographis paniculata (standardized for 50% bioactive andrographolides).Andrographis paniculata may have an effect on increasing the expression of collagen type II protein and also mitigate the migration of inflammatory cells or angiogenesis
Sponsor aimed to study hydroalcoholic extract of Andrographis paniculata (for its effect on OA disease progression in OA patients with moderate to severe knee OA. Hydroalcoholic extract of Andrographis paniculata (standardized for 50% bioactive andrographolides). It has been evaluated in clinical studies for its anti-inflammatory and anti-oxidant activities. Although the potential cartilage regenerative mechanism of Andrographis paniculata is unknown, Sponsor believe that Andrographis paniculata may have an effect on increasing the expression of collagen type II protein and also mitigate the migration of inflammatory cells or angiogenesis. In the present study, knee morphometrics (joint space narrowing of tibiofemoral joint, and cartilage thickness at the femur, tibia and patella compartments), cartilage turnover (serum COMP levels), bone turnover (serum Bone specific alkaline phosphatase) along with symptomatic relief (Using mWOMAC) in patients with primary knee OA over a period of 336 days will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
80
One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime
One capsule to be taken orally, 30 minutes after breakfast \& 30 minutes before bedtime
Ayush Nursing Home
Mumbai, Maharashtra, India
New Healthcare Nursing Home
Thane, Maharashtra, India
Jaipur National University Institute for Medical Sciences and Research Center
Jaipur, Rajasthan, India
Asopa Hospital
Jaipur, Rajasthan, India
Joint Space Narrowing as assessed by magnetic resonance imaging
to evaluate the effect of 336 days of IP consumption on change in joint space narrowing (JSN) in the tibiofemoral joint of knee as measured by magnetic resonance imaging (MRI)
Time frame: Day 0 and day 336
Modified Western Ontario and McMaster Universities Pain and total scores
Patients rate their pain, stiffness, or physical function using five ordinal responses: none, mild, moderate, severe, and extreme..Change in knee joint pain as assessed by the Western Ontario and McMaster University Arthritis Index pain subscale (mWOMAC -P)
Time frame: day 0, 28, 84, 140, 168, 252 and day 336
Cartilage thickness at femur, tibia and patella compartments
Change in cartilage thickness at the femur, tibia and patella compartments as assessed by MRI
Time frame: Day 0 and day 336
Outcome Measures in Arthritis Clinical Trials OA Research Society International
Treatment responders as assessed by OMERACT-OARSI in comparison to placebo
Time frame: day 336
Bone turnover (by measuring bone specific alkaline phosphatase levels)
Change in bone turnover as assessed by change in serum levels of bone specific alkaline phosphatase
Time frame: Day 0 and day 336
Cartilage turnover as assessed by Cartilage Oligomeric matrix protein (COMP)
Change in cartilage turnover as assessed by change in serum levels of cartilage oligomeric matrix protein
Time frame: Day 0 and day 336
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Shubham Sudbhawana Super Specialty Hospital
Varanasi, Uttar Pradesh, India
Change in the Quality of Life
Change in Quality of life as assessed by using Short Form-36
Time frame: Day 0, 84, 168, and day 336