Clinical Evaluation of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study
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|ClinicalTrials.gov Identifier: NCT03066089|
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Fenfuro||Phase 4|
Diabetes mellitus, involving rise in blood sugar levels, has shown to be a highly prevalent disease. Treatments and treatment regimens include combinations of oral anti-diabetic drugs (OADs), anti-hypertensive medications and anti-dyslipidemic agents, but these have been less than successful in managing their respective disease targets with clinical goals. Now-a-days, the treatment strategies for diabetes mellitus type 2 which are opted by general population include natural supplements. This choice is based upon the involvement of very less side effects along with high effectiveness of the natural supplements as compared to the synthetic medications. One of those natural supplements is fenugreek seeds extract i.e. Fenfuro which has been used as a nutraceutical in the present study for the management of type 2 diabetes mellitus.
Fenugreek has been extensively used as a source of anti-diabetic compounds from long time. Thus, Fenfuro, prepared from fenugreek seeds extract, is supposed to have anti-diabetic properties as well. Previous studies on fenugreek seeds extract have shown effective and safe anti-diabetic and anti-hyperlipidemic properties of it. It has shown to decrease blood glucose levels as well as lipid profile of the diabetic patients.
In this proposed study, Fenugreek seed extract will be used as an 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 (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Open Labeled, Interventional, Two Armed, Single Centric Study to Assess the Efficacy of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study|
|Actual Study Start Date :||December 14, 2015|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Group A
Fenfuro 500 mg capsule by mouth, BD (two times a day), till next follow-up
Other Name: Fenugreek seed extract
No Intervention: Group B
Investigational product is not being administered to this arm. This arm will regularly be observed on follow-up and laboratory investigations will be performed.
- Change in Fasting Blood Sugar [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
- Change in Postprandial sugar [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
- Change in HbA1c levels [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
- SGPT,SGOT,ALP,Creatinine,TLC,DLC & Hb [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066089
|Gian Sagar Medical College & Hospital|
|Rajpura, Punjab, India, 140601|