The use of functional scale WOMAC is an established
validated scale for the evaluation of pain as a manifestation
of OA. A number of national and international studies have
been conducted using the same (Clegg et al. 2006; Bellamy
1989). However, in the present study the source WOMAC
modified for Indian use (CRD Pune version) validated in
the previous studies was used for convenience (Chopra
et al. 2004). A differential response as a significant
decrease in algofunctional parameters was observed in
patients treated with NR-INF-02 compared to placebo and
its combination with GS. The failure to observe similar
response in patients treated with GS alone may be attributed
to its lack of optimal anti-inflammatory effects within
42 days of treatment as against 6-month treatment in the
previous study (Clegg et al. 2006). Further, a recent metaanalysis
on glucosamine and chondroitin supplements hasreported that the joint health ingredients do not reduce joint
pain or have a significant impact on narrowing of joint
space (Wandel et al. 2010) indicating lack of their efficacy
on structural changes. In addition, it may be important to
note that the unfavorable pharmacokinetic characteristic
profile of regular GS formulation involving negligible
concentration attainable in the joint cartilage may be contributing
to observed ineffectiveness in OA (Kulkarni
2012). Surprisingly, the combination of GS and NR-INF-
02 was not superior to effects of NR-INF-02 alone as
would be anticipated except in improving a few of the
clinical outcome parameters such as joint crepitation and
effusion in a limited number of patients.