Effect of Ambroxol in Diabetic Peripheral Neuropathy

Trial Title: Effect of Ambroxol in Diabetic Peripheral Neuropathy

NCT ID: NCT05558878

Condition: Diabetic Neuropathy Peripheral

Conditions: Official terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Ambroxol

Conditions: Keywords:
Diabetic Complications
Diabetic Peripheral Neuropathy
Inflammatory markers
Tumor necrosis alpha
nuclear factor kappa-light-chain-enhancer of activated B cells
Oxidative stress
Superoxide dismutase

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Ambroxol Oral Product
Description: 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.
Arm group label: Ambroxol (intervention arm)

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.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ain Shams university Hospital

Address:
City: Cairo
Country: Egypt

Start date: October 1, 2022

Completion date: November 2023

Lead sponsor:
Agency: Ain Shams University
Agency class: Other

Source: Ain Shams University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05558878