Navi Mumbai, India
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Raghunatha Reddy K.R.,Bioneeds Laboratory Animals and Preclinical Services | Vinaya Babu S.N.,Bioneeds Laboratory Animals and Preclinical Services | Raghavendra N.,Bioneeds Laboratory Animals and Preclinical Services | Kuber V.V.,Tulip Laboratory Private Ltd | Nipanikar S.U.,Tulip Laboratory Private Ltd
International Journal of Pharma and Bio Sciences | Year: 2011

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 body weight/day, with a NOAEL (no-observed-adverse-effect-level) of greater than 350 mg/kg of body weight/day for systemic toxicity from repeated dose 28-day oral gavage administration. The present study demonstrates the non-adverse nature of the polyherbal formulation TLPL/AY/01/2008 on long term administration.

Raghunatha Reddy K.R.,Bioneeds Preclinical Services | Vinaya Babu S.N.,Bioneeds Preclinical Services | Raghavendra N.,Bioneeds Preclinical Services | Sridhar M.,Bioneeds Preclinical Services | And 2 more authors.
Toxicology International | Year: 2013

Objectives: TLPL/AY/03/2008 is a polyherbal formulation intended for treatment of osteoarthritis, rheumatoid arthritis, lumbago, spondylitis etc., Acute and repeated dose 90-days studies were conducted to evaluate the safety profile of TLPL/AY/03/2008 in rats. Materials and Methods: In acute study, TLPL/AY/03/2008 was orally administered to Sprague Dawley rats at 2000 mg/kg. In repeated dose study, TLPL/AY/03/2008 was administered to rats at 200, 500 and 1000 mg/kg through oral gavage for 90 days and assessed for treatment related changes in body weight, feed consumption, hematological, biochemical and pathological parameters. Histopathological examination was conducted for tissues from control and the high dose groups and was extended to target organs from the lower dose and recovery groups. Results: In acute study, the test item did not produce any mortality or adverse clinical signs. In the 90-days oral toxicity study, animals did not exhibit any toxicity symptoms and no deaths were observed. No significant changes were found in hematological and biochemical endpoints. Also, toxicologically significant alterations in relative organ weights were not observed. Microscopic findings of mild to marked, diffuse hepatocellular degeneration (vacuolar changes with granular of cytoplasm and pyknotic nuclei of hepatocytes) was noticed in males at 1000 mg/kg body weight. Animals of recovery group (1000 mg/kg) did not show any changes when compared with control group animals indicating the complete reversal. Conclusions: Based on the findings of the study, the median lethal dose of TLPL/AY/03/2008 was found to be more than 2000 mg/kg. The No Observed Adverse Effect Level (NOAEL) of TLPL/AY/03/2008 can be considered as 1000 mg/kg in both male and female rats, under the experimental conditions and doses employed.

Munshi R.,Byl Nair Ch Hospital | Bhalerao S.,Byl Nair Ch Hospital | Rathi P.,Byl Nair Ch Hospital | Kuber V.V.,Tulip Laboratory Private Ltd | And 2 more authors.
Journal of Ayurveda and Integrative Medicine | Year: 2011

Functional constipation is one of the most common gastrointestinal symptoms across the globe. Its high prevalence rate, economic burden, and adverse implications on the quality of life make constipation a major public health issue. Though various treatment options are available for the management of constipation, evidence for their efficacy and safety are limited. An open-label, prospective, interventional, and exploratory clinical trial was carried out to evaluate the efficacy and safety of "TLPL/AY/01/2008" in 34 patients suffering from functional constipation. "TLPL/AY/01/2008" is an Ayurvedic proprietary polyherbal formulation in powder form, containing Isabgol husk, Senna extract, and Triphala extract. Administration of "TLPL/AY/01/2008" for 14 days showed a significant increase in mean weekly bowel movements from 10.19 ± 05.64 to 18.29 ± 05.72 (P<0.05). The mean average time spent on toilet for bowel evacuation reduced significantly from 11.02 ± 05.43 minutes (baseline value) to 08.70 ± 04.72 minutes on day 14 (P<0.05). Mean stool form score assessed on Bristol stool form scale was improved from 02.97 ± 00.48 (baseline value) to 04.61 ± 00.84 (P<0.05) on day 14. A significant improvement (P<0.05) was also noted in straining during defecation, sensation of incomplete evacuation, sensation of anorectal blockage, and other associated symptoms of functional constipation. The significant improvement in most of the above symptoms was endured for a post-treatment observatory period of one week. All the study patients showed an excellent tolerability to the study drug. These findings suggest that "TLPL/AY/01/2008" is an effective, safe, and non-habit-forming herbal laxative formulation for the management of constipation. Comparative clinical studies with larger sample size would be able to confirm the above findings.

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