Anti-diabetic Effects of Persimmon Leaf Extract | NCT02706821

Studies
Anti-diabetic Effects of Persimmon Leaf Extract

NCT02706821

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

Mar 15, 2016Estimated

Enrollment

34Actual

Phase

Not Applicable

Conditions

Prediabetes

Interventions

Persimmon leaf extract
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Mar 8, 2016

First Submission Date that Met QC Criteria

Mar 8, 2016

First Posted Date

Mar 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2016

Last Update Posted Date

Mar 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo-Wan Chae, Professor, Chonbuk National University HospitalPrincipal Investigator

Lead Sponsor

Chonbuk National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose. The investigators measures changes in diabetes associated parameters, including fasting blood glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment sequence 1	Active Comparator	PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks.	Dietary Supplement: Persimmon leaf extract Dietary Supplement: Placebo
Treatment sequence 2	Active Comparator	Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks.	Dietary Supplement: Persimmon leaf extract Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Persimmon leaf extract	Dietary Supplement	Persimmon leaf extract (PLE), crossover design	Treatment sequence 1 Treatment sequence 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fasting and postprandial plasma glucose		baseline day 57, 85 and 141

Secondary Outcomes

Measure	Description	Time Frame
Fasting plasma insulin		baseline and day 57, 85 and 141
C-peptide		baseline and day 57, 85 and 141
Glycated hemoglobin (HbA1c)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-75 years
Fasting blood glucose (FPG) 100~140 mg/dL or postprandial blood glucose (PPG) 140~250 mg/dL

Exclusion Criteria:

FPG more than 140 mg/dL
2h PPG more than 200 mg/dL
Type 1 diabetes or HbA1c more than 9.0%
treatment with corticosteroids within the past 4 weeks
cardiovascular disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011236	Prediabetic State

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided