An open label, prospective, clinical study on a polyherbal formulation in osteoarthritis of knee

Background: Currently, though pharmacological, mechanical, and surgical interventions are used, there is no known cure for osteoarthritis (OA). Objectives: 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). Materials and 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. Conclusion: The study provides good evidence in support of the efficacy and safety of the ′TLPL/AY/03/2008′ in OA of knee

International Journal of Pharma and Bio Sciences RESEARCH ARTICLE PHARMACOLOGY ACUTE AND 28-DAY REPEATED DOSE TOXICITY STUDIES WITH POLYHERBAL FORMULATION OF ISABGOL HUSK, SWARNAPATRI LEAF EXTRACT AND TRIPHALA FRUITS EXTRACT (TLPL/AY/01/2008)

The acute and sub-chronic 28-day repeated dose toxicity studies in rodents were performed to assess the safety of polyherbal formulation of Isabgol husk (Plantago ovate), Swarnapatri leaf extract (Cassia angustifolia) and Triphala fruits extract (Emblica officinalis, Terminalia chebula and Terminalia belerica) (TLPL/AY/01/2008). The studies were conducted according to current OECD toxicology guidelines for acute and repeated dose. No mortalities or evidence of adverse effects were observed following acute oral gavage administration up to 2000 mg/kg of TLPL/AY/01/2008 in Sprague dawley rats. The 28-day repeated dose study involving daily oral administration of 70, 175 and 350 mg/kg body weight of TLPL/AY/01/2008, with a post trial 14 day no treatment observation period at high dose level, resulted in no clinical signs and animal deaths. No toxicological significant differences were observed in any of the TLPL/AY/01/2008 treatment groups for body weights, feed consumption, physical appearance, neurological behaviour and urine analysis. Evaluation of haematology and clinical chemistry parameters revealed no toxicological and treatment related effects. No treatment related changes noted in absolute and relative organ weights. Macroscopic and microscopic evaluation of organs revealed no treatment related. Results of this study demonstrate that polyherbal formulation TLPL/AY/01/2008 is not acutely toxic at 2000 mg/kg of bod