Diabetic PolyneuropathyPhase 2NCT07148804
A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract
A Phase 2 study testing Fermented Deglycyrrhizinated Licorice and Non-fermented Deglycyrrhizinated Licorice in people with Diabetic Polyneuropathy, run by Helwan University at 1 site in Egypt.
Trial summary
This double-blind, placebo-controlled study evaluated the efficacy of oral α-amylase enzyme replacement therapy in treating early-stage diabetic polyneuropathy (DPN). The study was conducted at Al-Azhar University Hospitals with 83 diabetic patients randomized to receive either fermented deglycyrrhizinated licorice… Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Fermented Deglycyrrhizinated Licorice and Non-fermented Deglycyrrhizinated Licorice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 15 Aug 2024
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
- Age between 15 and 65 years
- Diabetes duration of 1-5 years
- Body Mass Index (BMI) < 30 kg/m²
- HbA1c < 9%
- Serum creatinine < 2mg/dL
Show all 9Show fewer
- Serum α-amylase < 45 IU/L (reference range: 28-100 IU/L)
- Vibration Perception Threshold (VPT) > 15V
- Absence of clinical symptoms of diabetic polyneuropathy
Who cannot join
- Treatment with medications that might influence nerve function (antiepileptic agents, tricyclic antidepressants, sympathomimetic agents)
- Presence of myopathies
- Presence of neuropathies from other causes
- Presence of malignancies
- Clinical symptoms of diabetic polyneuropathy
- Inability to comply with study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral α-Amylase Enzyme Replacement for the Treatment of Diabetic Polyneuropathy
This double-blind, placebo-controlled study evaluated the efficacy of oral α-amylase enzyme replacement therapy in treating early-stage diabetic polyneuropathy (DPN). The study was conducted at Al-Azhar University Hospitals with 83 diabetic patients randomized to receive either fermented deglycyrrhizinated licorice extract (FDGL) containing α-amylase enzyme (2500 IU/gm) or placebo for 6 months. Primary outcomes measured improvements in nerve conduction velocity and vibration perception threshold.
Read the detailed description
Diabetes mellitus complications continue to develop despite optimal glycemic control with insulin. Recent studies suggest that serum amylase deficiency correlates with the severity of diabetic complications. This study hypothesizes that α-amylase enzyme deficiency represents an enzymatic defect in the cascade between activated insulin receptors and mitochondrial energy liberation, contributing to diabetic complications.
α-amylase is a glycolytic enzyme that undergoes entero-pancreatic circulation and is proposed to be a precursor to key phosphorylating enzymes (glycogen phosphorylase, glucokinase, and hexokinase) essential for glycolysis. Supplementation with α-amylase may restore normal carbohydrate metabolism and prevent diabetic complications.
The study drug is a formulation rich in α-amylase enzyme prepared from fermented deglycyrrhizinated licorice root extract, also containing acid-lipase enzyme and naturally occurring flavonoids. The intervention was administered as 500mg capsules twice daily, one hour before meals, for 6 months alongside regular antidiabetic medications.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Fermented Deglycyrrhizinated Licorice, Non-fermented Deglycyrrhizinated Licorice
- Keywords
- Diabetic complications, Diabetic polyneuropathy, Amylase deficiency, Licorice, FDGL
- Medical subject headings
- Diabetic Neuropathies, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Deglycyrrhizinated LicoriceDrug
Oral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day).
Non-fermented Deglycyrrhizinated LicoriceDietary supplement
500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Fermented Deglycyrrhizinated Licorice | Active comparator | Oral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day). Receives: Drug: Fermented Deglycyrrhizinated Licorice |
| Placebo Comparator | Placebo comparator | 500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily. Receives: Dietary Supplement: Non-fermented Deglycyrrhizinated Licorice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Nerve Conduction Velocity (SCV)
Measurement of nerve conduction velocity in sural nerve using digital electromyography equipment
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
Motor Nerve Conduction Velocity (MCV)
Measurement of nerve conduction velocity in peroneal nerve using digital electromyography equipment
Measured: Baseline, 3 months, 6 months
Vibration Perception Threshold (VPT)
Measurement using biothesiometer at six points on each foot (big toe, metatarsal bases, instep, heel)
Measured: Baseline, 3 months, 6 months
Serum α-amylase Levels
Measurement of serum α-amylase concentration as marker of compliance and drug efficacy
Measured: Baseline, 3 months, 6 months
Sensory Nerve Action Potential Amplitude (SNAP)
Amplitude measurement in sural nerve
Measured: Baseline, 3 months, 6 months
Compound Muscle Action Potential Amplitude (CMAP)
Amplitude measurement in peroneal nerve
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start10 Jan 2023
- Primary completion1 Feb 2024
- Study completion15 Aug 2024
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 PolyneuropathyStudies 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
- 83 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
- NCT07148804
- Sponsor's protocol ID
- 6016A
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Massoud AMA, Massoud HMA, El-Shawarby AA, Elseidy MI. Randomized Double-blind Placebo-controlled study to evaluate the efficacy of fermented deglycyrrhizinated licorice for treatment of diabetic polyneuropathy. Endocrine. 2026 Feb 2;91(1):51. doi: 10.1007/s12020-025-04476-5.
PubMed 41627541
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral α-Amylase Enzyme Replacement for the Treatment of Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT07148804
- Acronym / sponsor ID
- 6016A
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Diabetic complications, Diabetic polyneuropathy, Amylase deficiency, Licorice, FDGL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 29 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 double-blind, placebo-controlled study evaluated the efficacy of oral α-amylase enzyme replacement therapy in treating early-stage diabetic polyneuropathy (DPN). The study was conducted at Al-Azhar University Hospitals with 83 diabetic patients randomized to receive either fermented deglycyrrhizinated licorice extract (FDGL) containing α-amylase enzyme (2500 IU/gm) or placebo for 6 months. Primary outcomes measured improvements in nerve conduction velocity and vibration perception threshold.
Detailed description
Diabetes mellitus complications continue to develop despite optimal glycemic control with insulin. Recent studies suggest that serum amylase deficiency correlates with the severity of diabetic complications. This study hypothesizes that α-amylase enzyme deficiency represents an enzymatic defect in the cascade between activated insulin receptors and mitochondrial energy liberation, contributing to diabetic complications.
α-amylase is a glycolytic enzyme that undergoes entero-pancreatic circulation and is proposed to be a precursor to key phosphorylating enzymes (glycogen phosphorylase, glucokinase, and hexokinase) essential for glycolysis. Supplementation with α-amylase may restore normal carbohydrate metabolism and prevent diabetic complications.
The study drug is a formulation rich in α-amylase enzyme prepared from fermented deglycyrrhizinated licorice root extract, also containing acid-lipase enzyme and naturally occurring flavonoids. The intervention was administered as 500mg capsules twice daily, one hour before meals, for 6 months alongside regular antidiabetic medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented Deglycyrrhizinated Licorice | Active comparator | Drug: Fermented Deglycyrrhizinated LicoriceOral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day). |
| Placebo Comparator | Placebo comparator | Dietary Supplement: Non-fermented Deglycyrrhizinated Licorice500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
- Age between 15 and 65 years
- Diabetes duration of 1-5 years
- Body Mass Index (BMI) < 30 kg/m²
- HbA1c < 9%
Key exclusion criteria (6 listed)
- Treatment with medications that might influence nerve function (antiepileptic agents, tricyclic antidepressants, sympathomimetic agents)
- Presence of myopathies
- Presence of neuropathies from other causes
- Presence of malignancies
- Clinical symptoms of diabetic polyneuropathy
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 LicoriceOral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day). | Drug | Fermented Deglycyrrhizinated Licorice |
| Non-fermented Deglycyrrhizinated Licorice500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily. | Dietary supplement | Placebo Comparator |
Primary outcome
Sensory Nerve Conduction Velocity (SCV)
Time frame: Baseline, 3 months, 6 months
Measurement of nerve conduction velocity in sural nerve using digital electromyography equipment
5 secondary outcomes
Motor Nerve Conduction Velocity (MCV)
Time frame: Baseline, 3 months, 6 months
Vibration Perception Threshold (VPT)
Time frame: Baseline, 3 months, 6 months
Serum α-amylase Levels
Time frame: Baseline, 3 months, 6 months
Sensory Nerve Action Potential Amplitude (SNAP)
Time frame: Baseline, 3 months, 6 months
Compound Muscle Action Potential Amplitude (CMAP)
Time frame: Baseline, 3 months, 6 months
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 29 Aug 2025.
- Derived from this study: PubMed 41627541Massoud AMA, Massoud HMA, El-Shawarby AA, Elseidy MI. Randomized Double-blind Placebo-controlled study to evaluate the efficacy of fermented deglycyrrhizinated licorice for treatment of diabetic polyneuropathy. Endocrine. 2026 Feb 2;91(1):51. doi: 10.1007/s12020-025-04476-5.
- 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.
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 and Non-fermented Deglycyrrhizinated Licorice in people with Diabetic Polyneuropathy, 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 9 inclusion and 6 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 29 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?
Sensory Nerve Conduction Velocity (SCV) (time frame: Baseline, 3 months, 6 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 NCT07148804, 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 29 Aug 2025.