Effect of Ambroxol in Diabetic Peripheral Neuropathy

Ain Shams University

Status: Not yet enrolling

Conditions: Diabetic Neuropathy Peripheral

Treatments: Drug: Ambroxol Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT05558878

Ambroxol in DPN

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Ambroxol (intervention arm)

Experimental group

Description:

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.

Treatment:

Drug: Ambroxol Oral Product

Control arm

No Intervention group

Description:

40 patients will receive conventional therapy for diabetic neuropathy for 3 months.