Effect of Ambroxol in Diabetic Peripheral Neuropathy
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|ClinicalTrials.gov Identifier: NCT05558878|
Recruitment Status : Not yet recruiting
First Posted : September 28, 2022
Last Update Posted : September 29, 2022
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy Peripheral||Drug: Ambroxol Oral Product||Not Applicable|
All patients presenting to the Endocrinology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
- Patients aged 18-75 years diagnosed with Type 2 Diabetes.
- Patients diagnosed with Peripheral Diabetic Neuropathy.
- 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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy|
|Estimated Study Start Date :||October 1, 2022|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||November 2023|
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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558878
|Contact: Beshoy Thabet, Bachelor of Pharmacy||+20 firstname.lastname@example.org|
|Ain Shams university Hospital|