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Effect of Ambroxol in Diabetic Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05558878
Recruitment Status : Not yet recruiting
First Posted : September 28, 2022
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
Beshoy Thabit, Ain Shams University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Peripheral Drug: Ambroxol Oral Product Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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.
No Intervention: Control arm
40 patients will receive conventional therapy for diabetic neuropathy for 3 months.


Outcome Measures
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Primary Outcome Measures :
  1. Effect of Ambroxol on Tumor necrosis factor alpha (TNF-α) [ Time Frame: 3 months ]
    Blood samples will be drawn at baseline and end of study to track changes in TNF-α using ELISA technique

  2. Effect of Ambroxol on NF-κB (or NF-kappaB, "nuclear factor kappa-light-chain-enhancer of activated B cells") [ Time Frame: 3 months ]
    Blood samples will be drawn at baseline and end of study to track changes in NF-kappaB levels using ELISA technique

  3. Effect of Ambroxol on Superoxide dismutase [ Time Frame: 3 months ]
    Blood samples will be drawn at baseline and end of study to track changes in Superoxide dismutase levels using spectrophotometric technique


Secondary Outcome Measures :
  1. Effect of Ambroxol on clinical outcome : Toronto clinical scoring systems (TCSS) [ Time Frame: 3 months ]
    Patient are going to be followed up every other week for detection of progression and severity of neuropathy.

  2. Effect of Ambroxol on clinical outcome : Michigan diabetic neuropathy score (MDNS) [ Time Frame: 3 months ]
    Patient are going to be followed up every other week for detection of progression and severity of neuropathy.

  3. Effect of Ambroxol on clinical outcome : Pain assessment using the Numeric rating scale NRS [ Time Frame: 3 months ]
    Patients are going to be followed up every other week to detect point decrease on pain scale


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558878


Contacts
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Contact: Beshoy Thabet, Bachelor of Pharmacy +20 1111058017 beshoy.thabit@pharma.asu.edu.eg

Locations
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Egypt
Ain Shams university Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Association, American Diabetes.
Soliman E,Gellido C.Diabetic Neuropathy. eMedicine.com March 29, 2002.
American Diabetes Association. Standardized measures in diabetic neuropathy. Diabetes Care 1996;19(1S):72S-92S.
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
Weiser T (2000) The secretolytic ambroxol blocks neuronal Na+channels. Soc Neurosci Abstr 454.14.

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Responsible Party: Beshoy Thabit, Clinical Pharmacy demonstrator, Ain Shams University
ClinicalTrials.gov Identifier: NCT05558878    
Other Study ID Numbers: Ambroxol in DPN
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beshoy Thabit, Ain Shams University:
Diabetic Complications
Diabetic Peripheral Neuropathy
Inflammatory markers
Tumor necrosis alpha
 nuclear factor kappa-light-chain-enhancer of activated B cells
Oxidative stress
Superoxide dismutase
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Ambroxol
Expectorants
Respiratory System Agents