Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes

Type-2 Diabetes Mellitus Clinical Trial

Official title:

Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes: An Add-On Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693392
• Other study ID #: T/EM-F/Pharma/14/05
• Status: Completed
• Phase: N/A
• Start date: January 17, 2016
• Est. completion date: August 16, 2018

Study information

• Verified date: August 2018
• Source: All India Institute of Medical Sciences, Bhubaneswar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 16, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type-2 Diabetes Mellitus

Intervention

Drug:
• Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]
Patients receiving either of the following oral hypoglycemic agents Sulfonylurea based oral hypoglycemic agents Metformin based oral hypoglycemic agents Metformin plus Sulfonylurea based oral hypoglycemic agents

Dietary Supplement:
• Fenugreek 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

Locations

Country	Name	City	State
India	Department of Medicine and Department of Pharmacology, AIIMS	Bhubaneswar	Odisha

Sponsors (2)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Bhubaneswar	Chemical Resources

Country where clinical trial is conducted

India, 

References & Publications (4)

Baquer NZ, Kumar P, Taha A, Kale RK, Cowsik SM, McLean P. Metabolic and molecular action of Trigonella foenum-graecum (fenugreek) and trace metals in experimental diabetic tissues. J Biosci. 2011 Jun;36(2):383-96. Review. — View Citation

Gupta A, Gupta R, Lal B. Effect of Trigonella foenum-graecum (fenugreek) seeds on glycaemic control and insulin resistance in type 2 diabetes mellitus: a double blind placebo controlled study. J Assoc Physicians India. 2001 Nov;49:1057-61. — View Citation

Hannan JM, Ali L, Rokeya B, Khaleque J, Akhter M, Flatt PR, Abdel-Wahab YH. Soluble dietary fibre fraction of Trigonella foenum-graecum (fenugreek) seed improves glucose homeostasis in animal models of type 1 and type 2 diabetes by delaying carbohydrate d — View Citation

Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a meta-analysis of clinical trials. Nutr J. 2014 Jan 18;13:7. doi: 10.1186/1475-2891-13-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin (HbA1c)	HbA1c will be evaluated using Hb variant (HPLC)	Change from baseline HbA1c over 12 weeks
Secondary	Fasting blood glucose	METHOD : SPECTROPHOTOMETRY HEXOKINASE	Change from baseline Fasting Blood Glucose over 12 weeks
Secondary	Serum Insulin	by CHEMILUMINESCENCE method	Change from baseline Serum Insulin over 12 weeks
Secondary	Serum C-Peptide	by CHEMILUMINESCENCE method	Change from baseline Serum C-Peptide over 12 weeks
Secondary	Renal Function Test	by Spectrophotometry	Change from baseline Renal function test over 12 weeks
Secondary	Liver Function Test	by Spectrophotometry	Change from baseline Liver function test over 12 weeks
Secondary	Hematology (whole blood cell count)	Automated particle cell counter and microscopy	Change from baseline Hematology over 12 weeks
Secondary	Urinary sugar	Semi-quantitative Biochemical test	Change from baseline Urinary over 12 weeks
Secondary	Post-prandial Blood Glucose	METHOD: SPECTROPHOTOMETRY HEXOKINASE	Change from baseline post-prandial Blood Glucose over 12 weeks