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

NCT ID: NCT04543422

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-01

Brief Summary

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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

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Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Green tea extracts

Patients in this arm received green tea extract capsules

Group Type EXPERIMENTAL

Green tea

Intervention Type DIETARY_SUPPLEMENT

Green tea extract capsules

Placebo

Patients in this arm received placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo containing inert material.

Interventions

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Green tea

Green tea extract capsules

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo containing inert material.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diabetic patients with peripheral neuropathy

Exclusion Criteria

* Patients under treatment of diabetic peripheral neuropathy.
* Patients with other causes of peripheral neuropathy.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Egyptian Biomedical Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Al-Azhar University Faculty of Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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EBRN298

Identifier Type: -

Identifier Source: org_study_id

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