We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 21, 2022
First Posted Date  ICMJE September 28, 2022
Last Update Posted Date September 29, 2022
Estimated Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2022)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2022)		 Effect of Ambroxol on inflammatory and oxidative stress markers [ Time Frame: 3 months ]
Blood samples will be drawn at baseline and end of study to track changes in the level of inflammatory markers :Tumor necrosis factor alpha (TNF-α), NF-κB (or NF-kappaB, "nuclear factor kappa-light-chain-enhancer of activated B cells") using ELISA technique and changes in oxidative stress marker ; Superoxide Dismutase using spectrophotometric assessment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2022)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2022)		 Effect of Ambroxol on clinical outcome [ Time Frame: 3 months ]
Patients will be assessed every other week . The clinical assessment will include a full clinical examination of the patients for classification of Diabetic peripheral neuropathy, staging of Diabetic peripheral neuropathy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ambroxol in Diabetic Peripheral Neuropathy
Official Title  ICMJE Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy Peripheral
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ambroxol Oral Product
  • No Intervention: Control arm
    40 patients will receive conventional therapy for diabetic neuropathy for 3 months.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2022)		 80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Beshoy Thabet, Bachelor of Pharmacy +20 1111058017 beshoy.thabit@pharma.asu.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05558878
Other Study ID Numbers  ICMJE Ambroxol in DPN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Beshoy Thabit, Ain Shams University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ain Shams University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP