NCT04543422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
Last Updated

September 10, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

August 29, 2020

Last Update Submit

September 3, 2020

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Toronto Clinical Scoring System

    Improvement describes the difference between baseline and post-intervention outcome parameters

    three months

Study Arms (2)

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

Green teaDIETARY_SUPPLEMENT

Green tea extract capsules

Green tea extracts
PlaceboOTHER

Placebo containing inert material.

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients with peripheral neuropathy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2020

First Posted

September 10, 2020

Study Start

January 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

September 10, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)