Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-10-01
Study Completion Date
2023-11-30
Brief Summary
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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
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Detailed Description
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All patients presenting to the Endocrinology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
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.
Eligible patients will be randomly assigned to one of 2 groups:
Group 1, Ambroxol group (n=40): Patients will receive conventional therapy for diabetic neuropathy in addition to ambroxol 450 mg/day divided into 3 doses (each dose consists of two 75mg tablets) daily for 3 months.
Group 2, Control group (n= 40): Patients will receive conventional therapy for diabetic neuropathy for 3 months.
All subjects will sign an informed consent statement prior to inclusion in the study.
Follow up evaluation :
All patients in both groups will be followed up every other week \& will be assessed for the following:
Diabetic neuropathy scoring, occurrence of side effects \& Pain assessment.
End of study evaluation :
After 3 months, all patients will be assessed for the same parameters assessed at baseline.
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.
Eligible patients will be randomly assigned to one of 2 groups:
Group 1, Ambroxol group (n=40): Patients will receive conventional therapy for diabetic neuropathy in addition to ambroxol 450 mg/day divided into 3 doses (each dose consists of two 75mg tablets) daily for 3 months.
Group 2, Control group (n= 40): Patients will receive conventional therapy for diabetic neuropathy for 3 months.
All subjects will sign an informed consent statement prior to inclusion in the study.
Follow up evaluation :
All patients in both groups will be followed up every other week \& will be assessed for the following:
Diabetic neuropathy scoring, occurrence of side effects \& Pain assessment.
End of study evaluation :
After 3 months, all patients will be assessed for the same parameters assessed at baseline.
Conditions
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Diabetic Neuropathy Peripheral
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Ambroxol (intervention arm)
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.
Group Type
EXPERIMENTAL
Ambroxol Oral Product
Intervention Type
DRUG
Drug: Ambroxol (75 mg capsule)
Ambroxol is a mucolytic and expectorant drug. Ambroxol has been approved as lozenges for topical analgesia of sore throat in pharyngitis owing to its local anesthetic properties. Anti-inflammatory properties of ambroxol were confirmed by numerous studies. Ambroxol affect neuronal transduction by blocking (TTX)-resistant Na+ channels (Nav1.8) in small (pain-sensing) dorsal root ganglion neurons more potently than TTX-sensitive channels.
Control arm
40 patients will receive conventional therapy for diabetic neuropathy for 3 months.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Ambroxol Oral Product
Drug: Ambroxol (75 mg capsule)
Ambroxol is a mucolytic and expectorant drug. Ambroxol has been approved as lozenges for topical analgesia of sore throat in pharyngitis owing to its local anesthetic properties. Anti-inflammatory properties of ambroxol were confirmed by numerous studies. Ambroxol affect neuronal transduction by blocking (TTX)-resistant Na+ channels (Nav1.8) in small (pain-sensing) dorsal root ganglion neurons more potently than TTX-sensitive channels.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Patients aged 18-75 years diagnosed with Type 2 Diabetes.
* Patients diagnosed with Peripheral Diabetic Neuropathy.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ain Shams University
OTHER
Sponsor Role
lead
Responsible Party
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Beshoy Thabit
Clinical Pharmacy demonstrator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Ain Shams university Hospital
Cairo, , Egypt
Site Status
Countries
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Egypt
Central Contacts
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References
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Association, American Diabetes.
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Saeedi 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.
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Gregg 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.
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Dyck PJ, Albers JW, Andersen H, Arezzo JC, Biessels GJ, Bril V, Feldman EL, Litchy WJ, O'Brien PC, Russell JW; Toronto Expert Panel on Diabetic Neuropathy. Diabetic polyneuropathies: update on research definition, diagnostic criteria and estimation of severity. Diabetes Metab Res Rev. 2011 Oct;27(7):620-8. doi: 10.1002/dmrr.1226.
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Thomas PK. Classification, differential diagnosis, and staging of diabetic peripheral neuropathy. Diabetes. 1997 Sep;46 Suppl 2:S54-7. doi: 10.2337/diab.46.2.s54.
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Elmarakby AA, Sullivan JC. Relationship between oxidative stress and inflammatory cytokines in diabetic nephropathy. Cardiovasc Ther. 2012 Feb;30(1):49-59. doi: 10.1111/j.1755-5922.2010.00218.x. Epub 2010 Aug 16.
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Sandireddy R, Yerra VG, Areti A, Komirishetty P, Kumar A. Neuroinflammation and oxidative stress in diabetic neuropathy: futuristic strategies based on these targets. Int J Endocrinol. 2014;2014:674987. doi: 10.1155/2014/674987. Epub 2014 Apr 30.
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Kasznicki J, Kosmalski M, Sliwinska A, Mrowicka M, Stanczyk M, Majsterek I, Drzewoski J. Evaluation of oxidative stress markers in pathogenesis of diabetic neuropathy. Mol Biol Rep. 2012 Sep;39(9):8669-78. doi: 10.1007/s11033-012-1722-9. Epub 2012 Jun 21.
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Ganesh Yerra V, Negi G, Sharma SS, Kumar A. Potential therapeutic effects of the simultaneous targeting of the Nrf2 and NF-kappaB pathways in diabetic neuropathy. Redox Biol. 2013 Aug 1;1(1):394-7. doi: 10.1016/j.redox.2013.07.005.
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Sheikh, W. M. E., Alahmar, I. E., Salem, G. M., & El-Sheikh, M. A. (2019). Tumor necrosis factor alpha in peripheral neuropathy in type 2 diabetes mellitus. Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 55(1), 1-7. https://doi.org/10.1186/s41983-019-0080-0
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Heidari N, Sajedi F, Mohammadi Y, Mirjalili M, Mehrpooya M. Ameliorative Effects Of N-Acetylcysteine As Adjunct Therapy On Symptoms Of Painful Diabetic Neuropathy. J Pain Res. 2019 Nov 19;12:3147-3159. doi: 10.2147/JPR.S228255. eCollection 2019.
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Vallianou N, Evangelopoulos A, Koutalas P. Alpha-lipoic Acid and diabetic neuropathy. Rev Diabet Stud. 2009 Winter;6(4):230-6. doi: 10.1900/RDS.2009.6.230. Epub 2009 Dec 30.
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Beeh KM, Beier J, Esperester A, Paul LD. Antiinflammatory properties of ambroxol. Eur J Med Res. 2008 Dec 3;13(12):557-62.
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Su X, Wang L, Song Y, Bai C. Inhibition of inflammatory responses by ambroxol, a mucolytic agent, in a murine model of acute lung injury induced by lipopolysaccharide. Intensive Care Med. 2004 Jan;30(1):133-40. doi: 10.1007/s00134-003-2001-y. Epub 2003 Sep 20.
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Xia DH, Xi L, Xv C, Mao WD, Shen WS, Shu ZQ, Yang HZ, Dai M. The protective effects of ambroxol on radiation lung injury and influence on production of transforming growth factor beta1 and tumor necrosis factor alpha. Med Oncol. 2010 Sep;27(3):697-701. doi: 10.1007/s12032-009-9271-3. Epub 2009 Jul 28.
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Sunkari S, Thatikonda S, Pooladanda V, Challa VS, Godugu C. Protective effects of ambroxol in psoriasis like skin inflammation: Exploration of possible mechanisms. Int Immunopharmacol. 2019 Jun;71:301-312. doi: 10.1016/j.intimp.2019.03.035. Epub 2019 Mar 29.
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Puschmann S, Engelhorn R. [Pharmacological study on the bromhexine metabolite ambroxol (author's transl)]. Arzneimittelforschung. 1978;28(5a):889-98. No abstract available. German.
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Schutz A, Gund HJ, Pschorn U, Aicher B, Peil H, Muller A, de Mey C, Gillissen A. Local anaesthetic properties of ambroxol hydrochloride lozenges in view of sore throat. Clinical proof of concept. Arzneimittelforschung. 2002;52(3):194-9. doi: 10.1055/s-0031-1299879.
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Weiser T, Wilson N. Inhibition of tetrodotoxin (TTX)-resistant and TTX-sensitive neuronal Na(+) channels by the secretolytic ambroxol. Mol Pharmacol. 2002 Sep;62(3):433-8. doi: 10.1124/mol.62.3.433.
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Weiser T. Comparison of the effects of four Na+ channel analgesics on TTX-resistant Na+ currents in rat sensory neurons and recombinant Nav1.2 channels. Neurosci Lett. 2006 Mar 13;395(3):179-84. doi: 10.1016/j.neulet.2005.10.058. Epub 2005 Nov 15.
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Gaida W, Klinder K, Arndt K, Weiser T. Ambroxol, a Nav1.8-preferring Na(+) channel blocker, effectively suppresses pain symptoms in animal models of chronic, neuropathic and inflammatory pain. Neuropharmacology. 2005 Dec;49(8):1220-7. doi: 10.1016/j.neuropharm.2005.08.004. Epub 2005 Sep 21.
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Pawlinski L, Krawczyk M, Fiema M, Tobor E, Kiec-Wilk B. Dual-action ambroxol in treatment of chronic pain in Gaucher Disease. Eur J Pain. 2020 May;24(5):992-996. doi: 10.1002/ejp.1538. Epub 2020 Mar 9.
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Mullin S, Smith L, Lee K, D'Souza G, Woodgate P, Elflein J, Hallqvist J, Toffoli M, Streeter A, Hosking J, Heywood WE, Khengar R, Campbell P, Hehir J, Cable S, Mills K, Zetterberg H, Limousin P, Libri V, Foltynie T, Schapira AHV. Ambroxol for the Treatment of Patients With Parkinson Disease With and Without Glucocerebrosidase Gene Mutations: A Nonrandomized, Noncontrolled Trial. JAMA Neurol. 2020 Apr 1;77(4):427-434. doi: 10.1001/jamaneurol.2019.4611.
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Reference Type
BACKGROUND
Other Identifiers
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Ambroxol in DPN
Identifier Type: -
Identifier Source: org_study_id
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