Diabetic Neuropathy
Conditions
Keywords
FDGL, Diabetic neuropathy, Pain, Dose-finding
Brief 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. 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.
Interventions
DRUGFermented 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
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Concomitant chronic kidney disease * Hepatic impairment * Heart failure * Cancer * Major psychiatric disorders * Pregnancy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse effects | Throughout the 3-month study period | Percentage of participants experiencing adverse effects including headache, abdominal pain, nausea, or vomiting during the study period. |
Countries
Egypt
Outcome results
None listed