title: A multicenter clinical study to determine the efficacy of a novel fenugreek seed (Trigonella foenum-graecum) extract (Fenfuro™) in patients with type 2 diabetes.
abstract: BACKGROUND
  Trigonella foenum-graecum(fenugreek) seeds are known to exhibit potent antioxidant, hypoglycemic, and nephroprotective activities, as well as serve as excellent membrane stabilizers especially because of their content of novel furostanolic saponins. Our previous studies exhibited the broad spectrum safety and efficacy of Fenfuro, a novelT. foenum-graecumseed extract enriched in furostanolic saponins, in type 2 diabetes (T2D) in rats.
  
  
  METHODS
  This multicenter, randomized, placebo-controlled, double-blind, add-on clinical study evaluated over a period of 90 consecutive days the efficacy of Fenfuro (daily dosage: 500 mg bid) in 154 subjects (male: 108; female: 46; age: 25-60 years) with T2D.
  
  
  METHODS
  This study examined the body weight, blood pressure, and pulse rate, as well as the efficacy of Fenfuro on fasting and post-prandial plasma sugar (mg/dL), glycosylated hemoglobin (HbA1c), and fasting and post-prandial C-peptide levels.
  
  
  RESULTS
  Fenfuro caused significant reduction in both fasting plasma and post-prandial blood sugar levels. Approximately 83% of the subjects reported decreases in fasting plasma sugar levels in the Fenfuro-treated group as compared to 62% in the placebo group, while 89% of the subjects demonstrated reduction in post-prandial plasma sugar levels in the Fenfuro-treated group as compared to 72% in the placebo group. HbA1c levels were reduced in both placebo and treatment groups. The decrease in HbA1c levels was significant in both groups as compared to respective baseline values. A significant increase in fasting and post-prandial C-peptide levels compared to the respective baseline values was observed, while no significant changes in fasting and post-prandial C-peptide levels were observed between the two groups. No significant adverse effects were observed by blood chemistry analyses. Furthermore, 48.8% of the subjects reported reduced dosage of anti-diabetic therapy in the Fenfuro-treated group, whereas 18.05% reported reduced dosage of anti-diabetic therapy in the placebo group.
  
  
  CONCLUSIONS
  In summary, Fenfuro proved safe and efficacious in ameliorating the symptoms of T2D in humans.
authors.affiliation: Department of Physiology, King George's Medical University, Lucknow, India.|Department of Medicine, King George's Medical University, Lucknow, India.
authors.forename: Narsingh
authors.initials: N
authors.lastname: Verma
authors.affiliation: Department of Physiology, King George's Medical University, Lucknow, India.|Department of Medicine, King George's Medical University, Lucknow, India.
authors.forename: Kauser
authors.initials: K
authors.lastname: Usman
authors.affiliation: Department of Physiology, King George's Medical University, Lucknow, India.|Department of Medicine, King George's Medical University, Lucknow, India.
authors.forename: Naresh
authors.initials: N
authors.lastname: Patel
authors.affiliation: Department of Physiology, King George's Medical University, Lucknow, India.|Department of Medicine, King George's Medical University, Lucknow, India.
authors.forename: Arvind
authors.initials: A
authors.lastname: Jain
authors.affiliation: Department of Physiology, King George's Medical University, Lucknow, India.|Department of Medicine, King George's Medical University, Lucknow, India.
authors.forename: Sudhir
authors.initials: S
authors.lastname: Dhakre
authors.affiliation: Cepham Research Center, Piscataway, NJ, USA.
authors.forename: Anand
authors.initials: A
authors.lastname: Swaroop
authors.affiliation: Cepham Research Center, Piscataway, NJ, USA.
authors.forename: Manashi
authors.initials: M
authors.lastname: Bagchi
authors.affiliation: Research & Development, Chemical Resources, Panchkula, Haryana, India.
authors.forename: Pawan
authors.initials: P
authors.lastname: Kumar
authors.affiliation: Department of Biochemistry, Georgetown University Medical Center, Washington, DC, USA.|Department of Medicine, Georgetown University Medical Center, Washington, DC, USA.|Department of Pathology, Georgetown University Medical Center, Washington, DC, USA.
authors.forename: Harry G
authors.initials: HG
authors.lastname: Preuss
authors.affiliation: Cepham Research Center, Piscataway, NJ, USA.|Department of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, Houston, TX, USA; debasisbagchi@gmail.com.
authors.forename: Debasis
authors.initials: D
authors.lastname: Bagchi
keywords: C-peptide; HbA1c; blood pressure; blood sugar; fenugreek seed extract (Fenfuro); safety; type 2 diabetes (T2D)