title: An open label, prospective, clinical study on a polyherbal formulation in osteoarthritis of knee.
abstract: BACKGROUND
  Currently, though pharmacological, mechanical, and surgical interventions are used, there is no known cure for osteoarthritis (OA).
  
  
  OBJECTIVE
  The main aim of the study was to assess the efficacy and safety of "TLPL/AY/03/2008", a polyherbal formulation on knee joint pain assessed on visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
  
  
  METHODS
  It was an open label, single center, prospective, clinical study conducted in 36 patients of OA Knee. Two capsules of 'TLPL/AY/03/2008' were given to all patients twice daily orally after meals for 180 days.
  
  
  RESULTS
  Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. The mean joint pain (as assessed on VAS) reduced significantly (59.85%; P < 0.05) and the mean WOMAC combined score, WOMAC pain sub-score, WOMAC stiffness sub-score, and WOMAC difficulty sub-score also reduced significantly at the end of the study. The mean time taken by the patients to walk 50 feet too, was reduced significantly (25.26%) at the end of the study. At the end of 4 months of the treatment, no patient needed paracetamol as rescue medicine to control pain. Most of the patients had shown good overall improvement assessed by the physician and by the patients. Majority of the patients showed excellent tolerability to the study drug. No significant change in most of the safety laboratory parameters was observed at the end of the study.
  
  
  CONCLUSIONS
  The study provides good evidence in support of the efficacy and safety of the 'TLPL/AY/03/2008' in OA of knee.
authors.affiliation: Department of Medical Services, R and D Center, Tulip Lab Pvt. Ltd., Ranjangaon, Shirur, Pune, India.
authors.forename: Sanjay U
authors.initials: SU
authors.lastname: Nipanikar
authors.forename: Manjit
authors.initials: M
authors.lastname: Saluja
authors.forename: Vinod V
authors.initials: VV
authors.lastname: Kuber
authors.forename: Kalyan P
authors.initials: KP
authors.lastname: Kadbhane
authors.forename: Arvind
authors.initials: A
authors.lastname: Chopra
authors.forename: Namdev R
authors.initials: NR
authors.lastname: Khade
keywords: Efficacy; WOMAC osteoarthritis index; knee joint pain; osteoarthritis; polyherbal; quality of life; visual analogue scale