Type-2 Diabetes Mellitus
Conditions
Keywords
Fenugreek seed extract, HbA1c, Blood glucose
Brief summary
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.
Detailed description
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.
Interventions
DRUGOral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]
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
DIETARY_SUPPLEMENTFenugreek Seed extract
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
Sponsors
Chemical Resources
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients suffering from Type-2 Diabetes of less than 10 years duration * Patients with HbA1c \>7.0% * Patients with fasting plasma glucose not exceeding 180 mg/dL * Patients with Negative Urine sugar * Patients who are on oral hypoglycaemic agents containing either Metformin or Sulfonylurea or both * There should not be any change their in anti-diabetic treatment for at least one month
Exclusion criteria
* Patients with diabetes other than type-2 diabetes mellitus * Patients with evidence of renal disease (S. Creatinine \> 1.5mg/dL) * Patients with evidence of liver disease (AST/ALT \>3 times of normal * Pregnant and lactating mothers and women intending pregnancy * Patients who participated in any other clinical trial within the last 30 days * Patients with history of any hemoglobinopathy * History of intolerance or hypersensitivity to Fenugreek
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated hemoglobin (HbA1c) | Change from baseline HbA1c over 12 weeks | HbA1c will be evaluated using Hb variant (HPLC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Insulin | Change from baseline Serum Insulin over 12 weeks | by CHEMILUMINESCENCE method |
| Serum C-Peptide | Change from baseline Serum C-Peptide over 12 weeks | by CHEMILUMINESCENCE method |
| Renal Function Test | Change from baseline Renal function test over 12 weeks | by Spectrophotometry |
| Fasting blood glucose | Change from baseline Fasting Blood Glucose over 12 weeks | METHOD : SPECTROPHOTOMETRY HEXOKINASE |
| Hematology (whole blood cell count) | Change from baseline Hematology over 12 weeks | Automated particle cell counter and microscopy |
| Urinary sugar | Change from baseline Urinary over 12 weeks | Semi-quantitative Biochemical test |
| Post-prandial Blood Glucose | Change from baseline post-prandial Blood Glucose over 12 weeks | METHOD: SPECTROPHOTOMETRY HEXOKINASE |
| Liver Function Test | Change from baseline Liver function test over 12 weeks | by Spectrophotometry |
Countries
India
Outcome results
None listed