Clinical Evaluation of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study
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
1 other identifier
interventional
104
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes-mellitus
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2015
CompletedFirst Submitted
Initial submission to the registry
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJanuary 31, 2018
June 1, 2017
1.8 years
November 1, 2016
January 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Fasting Blood Sugar
On completion of treatment (i.e.12 weeks) as compared to baseline
Change in Postprandial sugar
On completion of treatment (i.e.12 weeks) as compared to baseline
Secondary Outcomes (2)
Change in HbA1c levels
On completion of treatment (i.e.12 weeks) as compared to baseline
SGPT,SGOT,ALP,Creatinine,TLC,DLC & Hb
On completion of treatment (i.e.12 weeks) as compared to baseline
Study Arms (2)
Group A
EXPERIMENTALFenfuro 500 mg capsule by mouth, BD (two times a day), till next follow-up
Group B
NO INTERVENTIONInvestigational product is not being administered to this arm. This arm will regularly be observed on follow-up and laboratory investigations will be performed.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gian Sagar Medical College & Hospital
Rajpura, Punjab, 140601, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2016
First Posted
February 28, 2017
Study Start
December 14, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
January 31, 2018
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share