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Ars pharm ; 62(1): 6-14, ene.-mar. 2021. graf
Artigo em Inglês | IBECS-Express | IBECS | ID: ibc-ET6-1765


INTRODUCTION: Khamira Gawzaban Ambari Jadwar Ood Saleeb Wala (KGAJOS) is a polyherbal compound Unani Pharmacopoeial formulation described in traditional Unani texts as Muqawwi-e-Aza-e-Raeesa (tonic for brain, heart, liver and stomach). KGAJOS is reported to possess anxiolytic and antidepressant activity in mice. Though it is used clinically for various neurological conditions, preclinical efficacy of this formulation in learning and memory enhancement / improvement is not established. METHOD: KGAJOS was evaluated for cognitive function improvement activity using Morris water maze test in C57BL/6 mice. Piracetam was used as positive control for comparison. Anymaze video tracking software was used for tracking the path of mice in pool as per standard protocol. RESULTS: During probe trial in Morris water maze test, a significant increase in time spent in platform quadrant was observed at 1000 and 1500 mg/kg bw of KGAJOS (p < 0.01 and 0.001, respectively) as well as in piracetam group (p < 0.01) compared to vehicle control. Latency to reach the platform quadrant (escape latency) was significantly reduced (p < 0.001) in piracetam and KGAJOS group at 1000 and 1500 mg/kg bw compared to vehicle control. No change in time spent in platform quadrant and escape latency was observed at 500 mg/kg bw of KGAJOS. CONCLUSIONS: Morris water maze experiment conducted in mice revealed improved learning and memory function of KGAJOS at the dose levels of 1000 and 1500 mg/kg bw whereas 500 mg/kg bw was not found to be effective. Ob¬served efficacy of KGAJOS confirmed the traditional claims and usage of this formulation in conditions associated with cognition and memory

INTRODUCCIÓN: Khamira Gawzaban Ambari Jadwar Ood Saleeb Wala (KGAJOS) es una formulación de Unani compuesto de poliherbal descrito como tónico para el cerebro, corazón, hígado y estómago. Este estudio se realizó para evaluar la eficacia preclínica de KGAJOS en el aprendizaje y la memoria. MÉTODO: Se evaluó la actividad de mejora de la función cognitiva de KGAJOS utilizando la prueba de laberinto de agua de Morris en ratones C57BL / 6. Se utilizó piracetam como control positivo. Se utilizó el software de seguimiento de video Anymaze para rastrear la ruta. RESULTADOS: Durante la prueba de la sonda, se observó un aumento significativo en el tiempo empleado en el cuadrante de la plataforma a 1000 y 1500 mg / kg de peso corporal de KGAJOS (p < 0,01 y 0,001, respectivamente) y en el grupo de piracetam (p < 0,01) en comparación con el control. La latencia para alcanzar el cuadrante de la plataforma (latencia de escape) se redujo significativamente (p < 0,001) en el grupo de piracetam y KGAJOS a 1000 y 1500 mg / kg de peso corporal en comparación con el control. CONCLUSIONES: El experimento del laberinto de agua de Morris reveló una mejora en la función de aprendizaje y memoria con 1000 y 1500 mg / kg de peso corporal de KGAJOS, mientras que 500 mg / kg de peso corporal no fue efectivo. La eficacia observada de KGAJOS confirmó las afirmaciones tradicionales y el uso de esta formulación en condiciones asociadas con la cognición y la memoria

Int J Pharm Investig ; 7(2): 41-46, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28929045


The recent amendments notified by the Government of India, for conducting clinical trial, is greatly appreciable as promoting safety and well-being of human subjects. These rules clearly state that medical management of injuries in clinical trials is mandatory, and clinical trial-related injury or death needs to be compensated over and above the medical management. These rules need to be reconsidered for simplification and better understanding of issues regarding compensation. There is a need of clarity at some points which should be discussed with all stakeholders for better understanding of current regulations. In our view, attention must also be given to academic investigators, during discussion to promote availability of cost-effective treatment in India.

Integr Med Res ; 6(1): 66-78, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28462146


BACKGROUND: Jawarish Jalinoos (JJ) is a classical semisolid traditional Unani formulation clinically used for the treatment of weakness of vital organs, liver, and stomach. Although JJ has been widely used clinically for several decades, no scientific report is available for its safety. METHODS: JJ and its sugar-free tablet version (SFJJ; formulated to target diabetic population) were assessed for safety in rats. Ninety-day repeated dose oral toxicity study was performed as per the Organisation for Economic Co-operation and Development Guideline 408. JJ was orally administered at the dose of 2000 mg/kg bw/d, whereas SFJJ was orally administered at the doses of 506 mg/kg body weight (bw)/d, 1012 mg/kg bw/d, and 2024 mg/kg bw/d for 90 days. The animals were periodically observed for clinical signs of toxicity, mortality, morbidity, body weight changes, and feed consumption. At the end of the study, hematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight, and histological examination were performed. RESULTS: Treatment with SFJJ and JJ showed no significant differences in body weight gain, feed consumption, hematology, clinical biochemistry, and serum electrolytes. No gross pathological findings and differences in relative organ weights were observed between control and drug treated rats. Histological examination revealed no toxicologically significant abnormalities related with SFJJ or JJ treatment. CONCLUSION: The 90-day repeated dose oral toxicity study demonstrates that the no observed adverse effect level of SFJJ and JJ is greater than 2024 mg/kg bw/d and 2000 mg/kg bw/d (p.o.) in rats, respectively. Both formulations were found to be safe up to the tested dose levels and experimental conditions, and therefore safe for clinical use as specified in the literature.