Effect of Ambroxol in Diabetic Peripheral Neuropathy

Diabetic Neuropathy Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05558878
• Other study ID #: Ambroxol in DPN
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: November 2023

Study information

• Verified date: September 2022
• Source: Ain Shams University
• Contact: Beshoy Thabet, Bachelor of Pharmacy
• Phone: +20 1111058017
• Email: beshoy.thabit[@]pharma.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy Peripheral
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ain Shams university Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Ambroxol on Tumor necrosis factor alpha (TNF-a)	Blood samples will be drawn at baseline and end of study to track changes in TNF-a using ELISA technique	3 months
Primary	Effect of Ambroxol on NF-?B (or NF-kappaB, "nuclear factor kappa-light-chain-enhancer of activated B cells")	Blood samples will be drawn at baseline and end of study to track changes in NF-kappaB levels using ELISA technique	3 months
Primary	Effect of Ambroxol on Superoxide dismutase	Blood samples will be drawn at baseline and end of study to track changes in Superoxide dismutase levels using spectrophotometric technique	3 months
Secondary	Effect of Ambroxol on clinical outcome : Toronto clinical scoring systems (TCSS)	Patient are going to be followed up every other week for detection of progression and severity of neuropathy.	3 months
Secondary	Effect of Ambroxol on clinical outcome : Michigan diabetic neuropathy score (MDNS)	Patient are going to be followed up every other week for detection of progression and severity of neuropathy.	3 months
Secondary	Effect of Ambroxol on clinical outcome : Pain assessment using the Numeric rating scale NRS	Patients are going to be followed up every other week to detect point decrease on pain scale	3 months