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NCT07148804
A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract
Phase 2 trial testing Fermented Deglycyrrhizinated Licorice in Diabetic Polyneuropathy in 83 participants. Completed in 15 August 2024.
1 February 2024
Quick facts
| Lead sponsor | Helwan University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 83 |
| Start date | 10 January 2023 |
| Primary completion | 1 February 2024 |
| Estimated completion | 15 August 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Fermented Deglycyrrhizinated Licorice — full drug profile →
- Non-fermented Deglycyrrhizinated Licorice
Conditions studied
- Diabetic Polyneuropathy — all drugs for Diabetic Polyneuropathy →
Sponsor
Helwan University
Who can join
Adults 15 to 65, any sex, with Diabetic Polyneuropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Randomized Double-blind Placebo-controlled study to evaluate the efficacy of fermented deglycyrrhizinated licorice for treatment of diabetic polyneuropathy.
Massoud AMA, Massoud HMA, El-Shawarby AA, Elseidy MI. · · 2026 · PMID 41627541 · DOI 10.1007/s12020-025-04476-5
Verify or expand the search:
- PubMed search for NCT07148804
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Helwan University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07148804 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Helwan University
- Last refreshed: 29 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07148804.
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