To assess the efficacy and safety of NILIN™ SR tablets in the management of osteoarthritis of knee
Int J Pharm Life Sci. 2012; 3(2):1413-23.
Osteoarthritis (OA) or degenerative joint disease is one of the oldest and most common types of arthritis, which leads to breakdown of the joint’s cartilage. This results in rubbing of bones against each other, causing pain and loss of movement. OA can range from mild to severe and it can affect hands, weight-bearing joints such as knees, hips, feet and the back.
Formulation of NILINTM SR contains Boswellin® (anti-inflammatory), Curcumin C3 Complex® (antioxidant) and Gingerol (anti-inflammatory, anti-oxidant, antiseptic and carminative).
To assess the efficacy and safety of NILINTM SR tablets in the management of osteoarthritis of knee.
A single centered, open-labeled clinical trial with 30 subjects from the age group 40-65 years having OA of knee, with no other rheumatologic condition was assessed. The total study duration was 90 days ± 14 days, of which patients study duration participation was for 56±7 days. Each subject received two tablets of NILINTM SR tablet for oral ingestion, twice a day for 56 days. Each tablet contains Curcuminoids -250 mg, Boswellia serrata extract (40 % AKBBA)-272 mg, Ginger extract (35 % Gingerol)-100mg.
The efficacy of NILINTM SR in the management of OA was tested on following parameters:
- Reduction of severity of pain.
- Improvement of joint function in patients with OA.
- Primary outcome measures were:
- Self-reported pain.
- Stiffness sub scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- 6 min walk distance.
- VAS scale measured at 0 h and 1, 2 and 4 h, respectively.
Secondary outcome measures included laboratory investigations and serological biomarker i.e. hs-CRP.
Results and Discussion:
- A significant improvement in the clinical and biochemical endpoints along with excellent tolerability indicates that NILINTM SR can be used for long term management of OA.
- WOMAC score of Wilcoxon paired sample was significantly decreased from day 3 onwards of the treatment for three parameters: Pain (P<0.002), Stiffness (P = 0.0017) and Physical disability (P=0.003). This difference got progressively more significant as the trial progressed till 56th day. This concluded that clinical efficacy of NILINTM SR led to symptomatic relief for the patients on the long-term basis and benefits are accumulative.
- A significant reduction in the Visual Analogue Scale (VAS) was seen directly from the first hour intake of the active tablet, and it continued till 4 hours of the tablet ingestion. This clearly demonstrates the early onset action of the tablet on pain in knee OA.
- A significant improvement in the 6-minute walk distance (P<0.05) and decrease in hs-CRP levels was observed.