Back to resultsGreen Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Green tea
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy
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.
Sites / Locations
- Al-Azhar University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Green tea extracts
Placebo
Arm Description
Patients in this arm received green tea extract capsules
Patients in this arm received placebo treatment
Outcomes
Primary Outcome Measures
Toronto Clinical Scoring System
Improvement describes the difference between baseline and post-intervention outcome parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT04543422
First Posted
August 29, 2020
Last Updated
September 3, 2020
Sponsor
Egyptian Biomedical Research Network
1. Study Identification
Unique Protocol Identification Number
NCT04543422
Brief Title
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy
Official Title
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egyptian Biomedical Research Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Green tea extracts
Arm Type
Experimental
Arm Description
Patients in this arm received green tea extract capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in this arm received placebo treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea
Intervention Description
Green tea extract capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo containing inert material.
Primary Outcome Measure Information:
Title
Toronto Clinical Scoring System
Description
Improvement describes the difference between baseline and post-intervention outcome parameters
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Al-Azhar University Faculty of Medicine
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy
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