Clinical trial · Interventional
Effect of Ambroxol in Diabetic Peripheral Neuropathy
Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy
NCT05558878CI-TRIAL-00061146unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective, randomized, controlled study will be conducted at Department of Endocrinology, Faculty of Medicine, Ain Shams University, assessing the efficacy of Ambroxol addition on the clinical outcome and inflammatory markers in Diabetic peripheral neuropathy patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetic Neuropathy Peripheral | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ambroxol Oral Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ambroxol (intervention arm)
- description
- 40 patients will receive conventional therapy for diabetic neuropathy in addition to ambroxol 450 mg/day divided into 3 doses (each dose consists of 2 75mg capsules) daily for 3 months.
- interventionNames
- Drug: Ambroxol Oral Product
- type
- NO_INTERVENTION
- label
- Control arm
- description
- 40 patients will receive conventional therapy for diabetic neuropathy for 3 months.
Primary outcomes (3)
- measure
- Effect of Ambroxol on Tumor necrosis factor alpha (TNF-α)
- timeFrame
- 3 months
- description
- Blood samples will be drawn at baseline and end of study to track changes in TNF-α using ELISA technique
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18-75 years diagnosed with Type 2 Diabetes. * Patients diagnosed with Peripheral Diabetic Neuropathy. Exclusion Criteria: * Patients with autoimmune disorders (Sjogren's syndrome, lupus, rheumatoid arthritis),inherited disorders causing PN (Charcot-Marie-Tooth), thyroid diseases, patients undergone gastroplasty surgery and cancer patients. * Pressure on or injury to the nerves * Patients with severe kidney or liver dysfunction. * Patients with recent history of / or ongoing infection. * Patients with cerebral vascular disease, vasculitis, peripheral arterial disease or claudication symptoms, toxic neuritis, vitamin B12 or folate deficiency, spondyloarthropathy, foot edema or ulcer and diagnosis of other neuromuscular disorders or neurodegenerative diseases. * Use of medications or supplements known to cause peripheral neuropathy. * Patients consuming alcohol, any antioxidant supplements or anti-inflammatory medicines and drug abuse. * Ketoacidosis or hypoglycemia resulting in hospital admission within the last 3 months. * Pregnancy or lactation or expecting to get pregnant during the study. * Medical, psychological, behavioral or pharmacological factors interfering with ability to participate in trial, collection or interpretation of study data. * Allergy to ambroxol.
References
Publications (35)
- BACKGROUNDAssociation, American Diabetes.
- BACKGROUNDSaeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10. PMID 31518657
- BACKGROUNDCandrilli SD, Davis KL, Kan HJ, Lucero MA, Rousculp MD. Prevalence and the associated burden of illness of symptoms of diabetic peripheral neuropathy and diabetic retinopathy. J Diabetes Complications. 2007 Sep-Oct;21(5):306-14. doi: 10.1016/j.jdiacomp.2006.08.002. PMID 17825755
- BACKGROUNDGregg EW, Sorlie P, Paulose-Ram R, Gu Q, Eberhardt MS, Wolz M, Burt V, Curtin L, Engelgau M, Geiss L; 1999-2000 national health and nutrition examination survey. Prevalence of lower-extremity disease in the US adult population >=40 years of age with and without diabetes: 1999-2000 national health and nutrition examination survey. Diabetes Care. 2004 Jul;27(7):1591-7. doi: 10.2337/diacare.27.7.1591. PMID 15220233
- BACKGROUNDAlbers JW, Pop-Busui R. Diabetic neuropathy: mechanisms, emerging treatments, and subtypes. Curr Neurol Neurosci Rep. 2014 Aug;14(8):473. doi: 10.1007/s11910-014-0473-5. PMID 24954624
- BACKGROUNDBoulton AJ, Malik RA. Diabetic neuropathy. Med Clin North Am. 1998 Jul;82(4):909-29. doi: 10.1016/s0025-7125(05)70029-8. PMID 9706126
- BACKGROUNDSoliman E,Gellido C.Diabetic Neuropathy. eMedicine.com March 29, 2002.
- BACKGROUNDAng L, Cowdin N, Mizokami-Stout K, Pop-Busui R. Update on the Management of Diabetic Neuropathy. Diabetes Spectr. 2018 Aug;31(3):224-233. doi: 10.2337/ds18-0036.