A Phase 4 interventional study of Fenfuro in Type 2 Diabetes Mellitus, sponsored by Chemical Resources. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Chemical Resources · Phase 4, Interventional, and Supportive care
This study is an open label, two armed trial evaluating the safety and efficacy of Fenfuro capsule twice daily for 90 days in 100 patients with type 2 diabetes that will be conducted in single center in India. The primary outcome measures will be the determination of decrease in plasma glucose levels from baseline to last visit. The secondary outcome will be the determination of safety of Fenfuro capsule in type 2 diabetic subjects.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 104 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Chemical Resources is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Fenfuro 500 mg capsule by mouth, BD (two times a day), till next follow-up
Drug: Fenfuro
Investigational product is not being administered to this arm. This arm will regularly be observed on follow-up and laboratory investigations will be performed.
Also known as: Fenugreek seed extract
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
Plan to share: No
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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