Clinical Evaluation of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chemical Resources
• Treatments: Fenugreek seed meal

Criteria

Inclusion Criteria:

• Agrees to written as well as audio-visual informed consent.

• Patients of either sex.

• Aged 18-65 years.

• Fasting plasma glucose level <180 mg/dL.

• HbA1c level more than 7.5%.

• Not receiving any steroids.

• Patient on anti-diabetic therapy.

Exclusion Criteria:

• Uncooperative Subjects.

• Diabetes other than type-2 diabetes mellitus.

• Evidence of renal & liver disease.

• History of any hemoglobinopathy that may affect determination of HbA1c.

• Lactating and Pregnant or planning to conceive females.

• Physically/ mentally unwell as certified by physician-in-charge.

• Participation in any other clinical trial with in the last 30 days.

• Subjects with allergy to investigational product.