Clinical study evaluating antihyperglycemic efficacy and safety of terminalia arjuna versus sitagliptin in Type-2 diabetes mellitus patients

一项评估Terminalia arjuna与西格列汀治疗2型糖尿病患者降血糖疗效和安全性的临床研究

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Abstract

Diabetes mellitus (DM) and its complications are devastating and our literature has mentioned different potentialities of terminalia arjuna, including antihyperglycemic effects, but majority researches done on animals, rarely clinical studies conducted. Our 3month study enrolling 60 DM patients analyzed bark of T.arjuna for its antihyperglycemic effects along with safety, group TAM: terminalia arjuna 1gm with metformin 500mg twice daily, group SGM: Sitagliptin 100mg once, with metformin 500mg twice daily. FBS, LFT and ADRs monitored at baseline, 4, 8 and 12 weeks, while HbA1c at baseline and 12weeks, FBS and HbA1c showed significant (<0.05) reduction in both groups, the reduction in FBS at 4, 8 & 12weeks in gpSGM vs gpTAM (FBS -29.50±8.86 vs -22.57±9.28, -46.03±9.73 vs 42.13±8.95, -62.80±9.06 vs -61.17±10.22) and in HbA1c at 12 weeks was comparable gpSGM vs gpTAM (HbA1c -0.90±0.34 vs 0.89±0.29) difference was non-significant (>0.05). On monitoring ADRs, gpSGM 2/30 had headache and 1/30 had nasopharyngitis initially during first 4weeks, which was revealed later on, while none had any side effects in gpTAM. Thus, concluding that both are equally efficacious as antihyperglycemic agent but terminalia arjuna has slight upper hand as is better tolerated in respect to any adverse drug reaction with comparable efficacy too.

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