In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.
Trigonella foenum-graecum, commonly known as Fenugreek, is a plant that has been extensively used as a source of antidiabetic compounds, from its seeds, leaves and extracts in different systems of medicine in asia. Fenugreek is traditionally used in India, especially in the Ayurvedic and Unani systems. Preliminary animal and human studies suggest possible hypoglycemic and anti-hyperlipidemic properties of fenugreek seed powder taken orally. In a randomized placebo controlled study conducted by Gupta et al showed that two month treatment with the hydro-alcoholic extract of fenugreek seeds improved glycemic control in 12 non-insulin dependent diabetes mellitus patients. In addition, there was improvement in insulin sensitivity and plasma lipid profile. Fenugreek extract was also well tolerated in diabetic patients. In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
Patients receiving either of the following oral hypoglycemic agents 1. Sulfonylurea based oral hypoglycemic agents 2. Metformin based oral hypoglycemic agents 3. Metformin plus Sulfonylurea based oral hypoglycemic agents
Patients recruited in the study arm will receive Capsule Fenfuro 500 milligram twice daily for 12 weeks as add-on intervention to the pre-specified oral hypoglycemic agents therapy
Department of Medicine and Department of Pharmacology, AIIMS
Bhubaneswar, Odisha, India
Glycosylated hemoglobin (HbA1c)
HbA1c will be evaluated using Hb variant (HPLC)
Time frame: Change from baseline HbA1c over 12 weeks
Fasting blood glucose
METHOD : SPECTROPHOTOMETRY HEXOKINASE
Time frame: Change from baseline Fasting Blood Glucose over 12 weeks
Serum Insulin
by CHEMILUMINESCENCE method
Time frame: Change from baseline Serum Insulin over 12 weeks
Serum C-Peptide
by CHEMILUMINESCENCE method
Time frame: Change from baseline Serum C-Peptide over 12 weeks
Renal Function Test
by Spectrophotometry
Time frame: Change from baseline Renal function test over 12 weeks
Liver Function Test
by Spectrophotometry
Time frame: Change from baseline Liver function test over 12 weeks
Hematology (whole blood cell count)
Automated particle cell counter and microscopy
Time frame: Change from baseline Hematology over 12 weeks
Urinary sugar
Semi-quantitative Biochemical test
Time frame: Change from baseline Urinary over 12 weeks
Post-prandial Blood Glucose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
METHOD: SPECTROPHOTOMETRY HEXOKINASE
Time frame: Change from baseline post-prandial Blood Glucose over 12 weeks