Green Tea Extracts for Mild-to-moderate Diabetic Peripher... | NCT04543422

Studies
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy

NCT04543422

Sponsor

Egyptian Biomedical Research Network

Status

Completed

Last Update Posted

Sep 10, 2020Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Diabetic Peripheral Neuropathy

Interventions

Green tea
Placebo

Countries

Egypt

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

Aug 2020

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

Jan 1, 2019Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Aug 29, 2020

First Submission Date that Met QC Criteria

Sep 3, 2020

First Posted Date

Sep 10, 2020Actual

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

Sep 3, 2020

Last Update Posted Date

Sep 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 present randomized placebo-controlled study aimed to evaluate the effect of green tea extract administration on the clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Green tea extracts	Experimental	Patients in this arm received green tea extract capsules	Dietary Supplement: Green tea
Placebo	Placebo Comparator	Patients in this arm received placebo treatment	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Green tea	Dietary Supplement	Green tea extract capsules	Green tea extracts

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Toronto Clinical Scoring System	Improvement describes the difference between baseline and post-intervention outcome parameters	three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic patients with peripheral neuropathy

Exclusion Criteria:

Patients under treatment of diabetic peripheral neuropathy.
Patients with other causes of peripheral neuropathy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Azhar University Faculty of Medicine		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013662	Tea

Ancestor Terms

ID	Term
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures
D001628	Beverages

Browse Leaves

Not provided

Browse Branches

Not provided