Diabetic NeuropathyPhase 2NCT07117942
FDGL Dose-Finding Study for Diabetic Neuropathy
A Phase 2 study testing Fermented Deglycyrrhizinated Licorice (FDGL) in people with Diabetic Neuropathy, run by Helwan University at 1 site in Egypt.
Trial summary
This study investigates the optimal dose of fermented deglycyrrhizinated licorice (FDGL) that maximizes both safety and efficacy in managing diabetic neuropathy complications in adults. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Fermented Deglycyrrhizinated Licorice (FDGL)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 485 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2020to 10 Apr 2023
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged between 18 and 70 years
- Documented history of type I or type II diabetes mellitus
- Confirmed diagnosis of at least one diabetes-related complication, including peripheral neuropathy
- Diagnosis of peripheral neuropathy confirmed in both lower extremities
- Numeric rating scores (VAS) on 0 to 10 scale ≥ 4 for at least 6 months in feet/legs
- Ability to provide written informed consent
- If using concurrent therapies for diabetic neuropathy (pregabalin, gabapentin, or duloxetine), must be on stable doses for at least 3 months prior to study start
Who cannot join
- Concomitant chronic kidney disease
- Hepatic impairment
- Heart failure
- Cancer
- Major psychiatric disorders
- Pregnancy
Show all 12Show fewer
- Refusal to sign informed consent
- Use of non-pharmacologic management strategies for diabetic neuropathy including:
- TENS (Transcutaneous Electrical Nerve Stimulation)
- Nerve block procedures
- Acupuncture
- Laser therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Different Doses of Fermented Deglycyrrhizinated Licorice (FDGL) in the Management of Diabetic Neuropathy: A Randomized Controlled Trial
This study investigates the optimal dose of fermented deglycyrrhizinated licorice (FDGL) that maximizes both safety and efficacy in managing diabetic neuropathy complications in adults. The study is a single-center, double-blind, parallel, placebo-controlled randomized clinical trial where patients with diabetic neuropathy are randomized to receive placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily doses of FDGL for three months. The primary objective is to determine the percentage improvement of diabetic neuropathy presentations and pain scores at three months relative to baseline.
Read the detailed description
This is a single-center, double-blinded, parallel, randomized clinical trial conducted at Al-Hussein University Hospital, Cairo, Egypt. Eligible patients are randomized to receive either placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily FDGL doses in a 1:1:1:1:1 ratio using block randomization with a block size of 5. The study employs computer-assisted random number generation for treatment allocation. Both patients and nurses are blinded to treatment allocation, with assignments kept in sealed envelopes opened only at enrollment. The study duration is 3 months with follow-up assessments at 1, 2, and 3 months.
- Conditions
- Diabetic Neuropathy
- Being tested
- Fermented Deglycyrrhizinated Licorice (FDGL)
- Keywords
- FDGL, Diabetic neuropathy, Pain, Dose-finding
- Medical subject headings
- Diabetic Neuropathies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Deglycyrrhizinated Licorice (FDGL)Drug
Fermented Deglycyrrhizinated Licorice (FDGL) in oral powder capsules; prepared through three consecutive steps: fermentation of licorice roots, removal of glycyrrhizinic acid content (deglycyrrhizination), and lyophilization according to EUROPEAN PATENT SPECIFICATION Ep 1 925 312 B
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo capsules administered daily for 3 months Receives: Drug: Fermented Deglycyrrhizinated Licorice (FDGL) |
| FDGL 400 mg | Experimental | Fermented Deglycyrrhizinated Licorice 400mg daily for 3 months Receives: Drug: Fermented Deglycyrrhizinated Licorice (FDGL) |
| FDGL 800 mg | Experimental | Fermented Deglycyrrhizinated Licorice 800mg daily for 3 months Receives: Drug: Fermented Deglycyrrhizinated Licorice (FDGL) |
| FDGL 1000 mg | Experimental | Fermented Deglycyrrhizinated Licorice 1000mg daily for 3 months Receives: Drug: Fermented Deglycyrrhizinated Licorice (FDGL) |
| FDGL 1200 mg | Experimental | Fermented Deglycyrrhizinated Licorice 1200mg daily for 3 months Receives: Drug: Fermented Deglycyrrhizinated Licorice (FDGL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The percentage improvement of diabetic neuropathy symptoms and pain scores (measured on a 0-10 scale where 0 = no pain and 10 = severe pain) at 3 months relative to baseline. This includes assessment of neuropathic complications in both lower extremities.
Measured: Baseline, 1 month, 2 months, and 3 months
Secondary outcomes (1)
Incidence of adverse effects
Percentage of participants experiencing adverse effects including headache, abdominal pain, nausea, or vomiting during the study period.
Measured: Throughout the 3-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start12 Feb 2020
- Primary completion18 Jun 2021
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud I Mostafa, Helwan University
- Investigators
- Ahmed Aly Massoud, PhD, Study chair, Department of Hepato-gastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117942
- Sponsor's protocol ID
- 6016
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Massoud A, Ebiary FHE, Raafat M, et al. The Effect of Fermented Deglycyrrhizinized Liquorice Extract on the Structure of Gastrocnemius Muscle and Sciatic Nerve in Experimentally Induced Diabetes Mellitus in Rats: Histopathological Study. J Cytol Histol 2019;10:1-8.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Different Doses of Fermented Deglycyrrhizinated Licorice (FDGL) in the Management of Diabetic Neuropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07117942
- Acronym / sponsor ID
- 6016
- Conditions
- Diabetic Neuropathy
- Keywords
- FDGL, Diabetic neuropathy, Pain, Dose-finding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 12 Aug 2025 (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.
This study investigates the optimal dose of fermented deglycyrrhizinated licorice (FDGL) that maximizes both safety and efficacy in managing diabetic neuropathy complications in adults. The study is a single-center, double-blind, parallel, placebo-controlled randomized clinical trial where patients with diabetic neuropathy are randomized to receive placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily doses of FDGL for three months. The primary objective is to determine the percentage improvement of diabetic neuropathy presentations and pain scores at three months relative to baseline.
Detailed description
This is a single-center, double-blinded, parallel, randomized clinical trial conducted at Al-Hussein University Hospital, Cairo, Egypt. Eligible patients are randomized to receive either placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily FDGL doses in a 1:1:1:1:1 ratio using block randomization with a block size of 5. The study employs computer-assisted random number generation for treatment allocation. Both patients and nurses are blinded to treatment allocation, with assignments kept in sealed envelopes opened only at enrollment. The study duration is 3 months with follow-up assessments at 1, 2, and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Fermented Deglycyrrhizinated Licorice (FDGL)Matching placebo capsules administered daily for 3 months |
| FDGL 400 mg | Experimental | Drug: Fermented Deglycyrrhizinated Licorice (FDGL)Fermented Deglycyrrhizinated Licorice 400mg daily for 3 months |
| FDGL 800 mg | Experimental | Drug: Fermented Deglycyrrhizinated Licorice (FDGL)Fermented Deglycyrrhizinated Licorice 800mg daily for 3 months |
| FDGL 1000 mg | Experimental | Drug: Fermented Deglycyrrhizinated Licorice (FDGL)Fermented Deglycyrrhizinated Licorice 1000mg daily for 3 months |
| FDGL 1200 mg | Experimental | Drug: Fermented Deglycyrrhizinated Licorice (FDGL)Fermented Deglycyrrhizinated Licorice 1200mg daily for 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients aged between 18 and 70 years
- Documented history of type I or type II diabetes mellitus
- Confirmed diagnosis of at least one diabetes-related complication, including peripheral neuropathy
- Diagnosis of peripheral neuropathy confirmed in both lower extremities
- Numeric rating scores (VAS) on 0 to 10 scale ≥ 4 for at least 6 months in feet/legs
Key exclusion criteria (12 listed)
- Concomitant chronic kidney disease
- Hepatic impairment
- Heart failure
- Cancer
- Major psychiatric disorders
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 |
|---|---|---|
| Fermented Deglycyrrhizinated Licorice (FDGL)Fermented Deglycyrrhizinated Licorice (FDGL) in oral powder capsules; prepared through three consecutive steps: fermentation of licorice roots, removal of glycyrrhizinic acid content (deglycyrrhizination), and lyophilization according to EUROPEAN PATENT SPECIFICATION Ep 1 925 312 B | Drug | FDGL 1000 mg, FDGL 1200 mg, FDGL 400 mg, FDGL 800 mg, Placebo |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline, 1 month, 2 months, and 3 months
The percentage improvement of diabetic neuropathy symptoms and pain scores (measured on a 0-10 scale where 0 = no pain and 10 = severe pain) at 3 months relative to baseline. This includes assessment of neuropathic complications in both lower extremities.
1 secondary outcome
Incidence of adverse effects
Time frame: Throughout the 3-month study period
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 17 Aug 2025.
- BackgroundMassoud A, Ebiary FHE, Raafat M, et al. The Effect of Fermented Deglycyrrhizinized Liquorice Extract on the Structure of Gastrocnemius Muscle and Sciatic Nerve in Experimentally Induced Diabetes Mellitus in Rats: Histopathological Study. J Cytol Histol 2019;10:1-8.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Aly Massoud, PhD study chair
Department of Hepato-gastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fermented Deglycyrrhizinated Licorice (FDGL) in people with Diabetic Neuropathy, run by Helwan University 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 7 inclusion and 12 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 17 Aug 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual Analog Scale (VAS) (time frame: Baseline, 1 month, 2 months, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07117942, which also lists 1 linked publication.
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 17 Aug 2025.