Effect of Ambroxol in Diabetic Peripheral Neuropathy

September 27, 2022 updated by: Beshoy Thabit, Ain Shams University

Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ambroxol in DPN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Neuropathy Peripheral

Clinical Trials on Ambroxol Oral Product

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe