Diabetic Peripheral NeuropathyNCT04543422
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy
A study testing Green tea in people with Diabetic Peripheral Neuropathy, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Green tea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients with peripheral neuropathy
Who cannot join
- Patients under treatment of diabetic peripheral neuropathy.
- Patients with other causes of peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy A Randomized Controlled Trial
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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Green tea, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaDietary supplement
Green tea extract capsules
PlaceboOther
Placebo containing inert material.
| Study group | Role | What they receive |
|---|---|---|
| Green tea extracts | Experimental | Patients in this arm received green tea extract capsules Receives: Dietary Supplement: Green tea |
| Placebo | Placebo comparator | Patients in this arm received placebo treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Clinical Scoring System
Improvement describes the difference between baseline and post-intervention outcome parameters
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543422
- Sponsor's protocol ID
- EBRN298
- Status last verified
- Aug 2020
- First submitted
- 29 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04543422
- Acronym / sponsor ID
- EBRN298
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green tea extracts | Experimental | Dietary Supplement: Green teaPatients in this arm received green tea extract capsules |
| Placebo | Placebo comparator | Other: PlaceboPatients in this arm received placebo treatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients with peripheral neuropathy
Key exclusion criteria (2 listed)
- Patients under treatment of diabetic peripheral neuropathy.
- Patients with other causes of peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green teaGreen tea extract capsules | Dietary supplement | Green tea extracts |
| PlaceboPlacebo containing inert material. | Other | Placebo |
Primary outcome
Toronto Clinical Scoring System
Time frame: three months
Improvement describes the difference between baseline and post-intervention outcome parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea in people with Diabetic Peripheral Neuropathy, run by Egyptian Biomedical Research Network at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Clinical Scoring System (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.