A randomized double blind placebo controlled trial to assess the safety and efficacy of a patented fenugreek (Trigonella foenum-graecum) seed extract in Type 2 diabetics
Authors
Rajinder Gupta
Department of Medicine, Gian Sagar Medical College & Hospital, Banur, Patiala, India
Partha Pal
Department of Statistics, Maulana Azad College, Kolkata, India
Manashi Bagchi
Department of R&D, Dr. Herbs LLC, Concord, CA, USA
Mehul Rungta
R&D Department, Chemical Resources (CHERESO), Panchkula, Haryana, India
Sanjoy Chakraborty
Department of Biological Sciences, New York City College of Technology/CUNY, Brooklyn, NY, USA
Samudra Banik
Department of Microbiology, Maulana Azad College, Kolkata, India
Apurva Goel
Regulatory Department, Chemical Resources (CHERESO), Panchkula, Haryana, India
Pawan Kumar
R&D Department, Chemical Resources (CHERESO), Panchkula, Haryana, India
Amarjit Grover
Department of Surgery, Gian Sagar Medical College & Hospital, Banur, Patiala, India
Debasis Bagchi
Department of Biology, College of Arts and Sciences, and Department of Psychology, Gordon F. Derner School of Psychology, Adelphi University, Garden City, NY, USA
Fenugreek plant (Trigonella foenum-graecum) constitutes a traditionally acclaimed herbal remedy for many human ailments including diabetes, obesity, neurodegenerative diseases, and reproductive disorders. It is also used as an effective anti-oxidative, anti-inflammatory, antibacterial, and anti-fungal agent. The seed of the plant is especially enriched in several bioactive molecules including polyphenols, saponins, alkaloids, and flavonoids and has demonstrated potential to act as an antidiabetic phytotherapeutic. A novel patented formulation (Fenfuro®) was developed in our laboratory from the fenugreek seeds which contained >45% furostanolic saponins (HPLC).
Objective
A placebo-controlled clinical compliance study was designed to assess the effects of complementing Fenfuro® on a randomized group of human volunteers on antidiabetic therapy (Metformin and sulphonylurea) in controlling the glycemic index along with simultaneous safety assessment.
Study methodology and trial design
In a randomized double-blind, placebo-controlled trial, 42 individuals (21 male and 21 female volunteers) in the treatment group (out of 57 enrolled) and 39 individuals (17 male and 22 female volunteers) in the placebo group (out of 47 enrolled), all on antidiabetic therapy with Metformin/Metformin with sulphonyl urea within the age group of 18–65 years were administered either 1,000 mg (500 mg × 2) (Fenfuro®) capsules or placebo over a period of 12 consecutive weeks. Fasting and postprandial glucose along with glycated hemoglobin were determined as primary outcomes to assess the antidiabetic potential of the formulation. Moreover, in order to evaluate the safety of the formulation, C-peptide and Thyroid Stimulating Hormone (TSH) levels as well as immunohematological parameters were assessed between the treatment and placebo groups at the completion of the study.
Results
After 12 weeks of administration, both fasting as well as postprandial serum glucose levels decreased by 38 and 44% respectively in the treatment group. Simultaneously, a significant reduction in glycated hemoglobin by about 34.7% was also noted. The formulation did not have any adverse effect on the study subjects as there was no significant change in C- peptide level and TSH level; liver, kidney, and cardiovascular function was also found to be normal as assessed by serum levels of key immunohematological parameters. No adverse events were reported.
Conclusion
This clinical compliance study re-instated and established the safety and efficacy of Fenfuro® as an effective phytotherapeutic to treat hyperglycemia.
Keywords: Fenugreek (Trigonella foenum-graecum) seeds, T2D, Clinical Investigation, Fasting Glucose, Post-Prandial Glucose, HbA1c, Antihyperglycemic therapeutic
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