The present study has many strengths: (1) the trial
product had a single ingredient (2) the study design was a
parallel group, placebo-controlled evaluation (3) validated
tools such as VAS and WOMAC were used for assessment
of efficacy along with CGIC (4) efficacy outcome also
included patients’ overall acceptability of the trial formulation
(5) study analysis was adjusted for the covariables
such as age, gender, and BMI which removed the confounding
variables. A few limitations to the present study
include—(1) a small sample size (2) the study design was a
single blind, due to differences in doses and formulations
(3) short treatment duration not sufficient enough to assess
safety and efficacy in long-term pain management (4) lastly
even though validated scales were used to assess the OA
pain these were subjective. It would have been appropriate
to document the improvement and future course of OA in
terms of preventing progression of structural damage seen
as pathological sequel of OA to confirm the reliable effi-
cacy outcome. The same was not possible due to shorter
duration of treatment which was inadequate to reflect on
these parameters. Hence, there is a need to confirm the
above results in a larger number of patients with longer
duration of treatment. However, the clinical and subjectivecorrelation of the achieved pain reduction is valid and the
study provides supportive evidence for the basic proof of
concept data on efficacy of NR-INF-02 for symptomatic
management of painful knee OA.