Diabetic Neuropathy PeripheralNCT05558878
Effect of Ambroxol in Diabetic Peripheral Neuropathy
A study testing Ambroxol Oral Product in people with Diabetic Neuropathy Peripheral, run by Ain Shams University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathy Peripheral
- What is being tested?
- Ambroxol Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years diagnosed with Type 2 Diabetes.
- Patients diagnosed with Peripheral Diabetic Neuropathy.
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy
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
Read the 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.
- Conditions
- Diabetic Neuropathy Peripheral
- Being tested
- Ambroxol Oral Product
- 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
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambroxol Oral ProductDrug
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 group | Role | What they receive |
|---|---|---|
| Ambroxol (intervention arm) | Experimental | 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. Receives: Drug: Ambroxol Oral Product |
| Control arm | No intervention | 40 patients will receive conventional therapy for diabetic neuropathy for 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Ambroxol on Tumor necrosis factor alpha (TNF-α)
Blood samples will be drawn at baseline and end of study to track changes in TNF-α using ELISA technique
Measured: 3 months
Effect of Ambroxol on NF-κB (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
Measured: 3 months
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
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy PeripheralStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beshoy Thabit, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558878
- Sponsor's protocol ID
- Ambroxol in DPN
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Association, American Diabetes.
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
PubMed 31518657Candrilli SD, Davis KL, Kan HJ, Lucero MA, Rousculp MD. Prevalence and the associated burden of illness of symptoms of diabetic peripheral neuropathy and diabetic retinopathy. J Diabetes Complications. 2007 Sep-Oct;21(5):306-14. doi: 10.1016/j.jdiacomp.2006.08.002.
PubMed 17825755Gregg EW, Sorlie P, Paulose-Ram R, Gu Q, Eberhardt MS, Wolz M, Burt V, Curtin L, Engelgau M, Geiss L; 1999-2000 national health and nutrition examination survey. Prevalence of lower-extremity disease in the US adult population >=40 years of age with and without diabetes: 1999-2000 national health and nutrition examination survey. Diabetes Care. 2004 Jul;27(7):1591-7. doi: 10.2337/diacare.27.7.1591.
PubMed 15220233Albers JW, Pop-Busui R. Diabetic neuropathy: mechanisms, emerging treatments, and subtypes. Curr Neurol Neurosci Rep. 2014 Aug;14(8):473. doi: 10.1007/s11910-014-0473-5.
PubMed 24954624Boulton AJ, Malik RA. Diabetic neuropathy. Med Clin North Am. 1998 Jul;82(4):909-29. doi: 10.1016/s0025-7125(05)70029-8.
PubMed 9706126Soliman E,Gellido C.Diabetic Neuropathy. eMedicine.com March 29, 2002.
Ang L, Cowdin N, Mizokami-Stout K, Pop-Busui R. Update on the Management of Diabetic Neuropathy. Diabetes Spectr. 2018 Aug;31(3):224-233. doi: 10.2337/ds18-0036.
PubMed 30140138Boulton AJ, Malik RA, Arezzo JC, Sosenko JM. Diabetic somatic neuropathies. Diabetes Care. 2004 Jun;27(6):1458-86. doi: 10.2337/diacare.27.6.1458. No abstract available.
PubMed 15161806Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, Malik RA, Maser RE, Sosenko JM, Ziegler D; American Diabetes Association. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005 Apr;28(4):956-62. doi: 10.2337/diacare.28.4.956. No abstract available.
PubMed 15793206Dyck PJ, Albers JW, Andersen H, Arezzo JC, Biessels GJ, Bril V, Feldman EL, Litchy WJ, O'Brien PC, Russell JW; Toronto Expert Panel on Diabetic Neuropathy. Diabetic polyneuropathies: update on research definition, diagnostic criteria and estimation of severity. Diabetes Metab Res Rev. 2011 Oct;27(7):620-8. doi: 10.1002/dmrr.1226.
PubMed 21695763Thomas PK. Classification, differential diagnosis, and staging of diabetic peripheral neuropathy. Diabetes. 1997 Sep;46 Suppl 2:S54-7. doi: 10.2337/diab.46.2.s54.
PubMed 9285500American Diabetes Association. Standardized measures in diabetic neuropathy. Diabetes Care 1996;19(1S):72S-92S.
Pang L, Lian X, Liu H, Zhang Y, Li Q, Cai Y, Ma H, Yu X. Understanding Diabetic Neuropathy: Focus on Oxidative Stress. Oxid Med Cell Longev. 2020 Jul 31;2020:9524635. doi: 10.1155/2020/9524635. eCollection 2020.
PubMed 32832011Elmarakby AA, Sullivan JC. Relationship between oxidative stress and inflammatory cytokines in diabetic nephropathy. Cardiovasc Ther. 2012 Feb;30(1):49-59. doi: 10.1111/j.1755-5922.2010.00218.x. Epub 2010 Aug 16.
PubMed 20718759
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05558878
- Acronym / sponsor ID
- Ambroxol in DPN
- Conditions
- Diabetic Neuropathy Peripheral
- 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
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambroxol (intervention arm) | Experimental | Drug: Ambroxol Oral Product40 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. |
| Control arm | No intervention | –40 patients will receive conventional therapy for diabetic neuropathy for 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-75 years diagnosed with Type 2 Diabetes.
- Patients diagnosed with Peripheral Diabetic Neuropathy.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambroxol Oral ProductDrug: 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. | Drug | Ambroxol (intervention arm) |
Primary outcome
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
3 secondary outcomes
Effect of Ambroxol on clinical outcome : Toronto clinical scoring systems (TCSS)
Time frame: 3 months
Effect of Ambroxol on clinical outcome : Michigan diabetic neuropathy score (MDNS)
Time frame: 3 months
Effect of Ambroxol on clinical outcome : Pain assessment using the Numeric rating scale NRS
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- BackgroundAssociation, American Diabetes.
- Background: PubMed 31518657Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
- Background: PubMed 17825755Candrilli SD, Davis KL, Kan HJ, Lucero MA, Rousculp MD. Prevalence and the associated burden of illness of symptoms of diabetic peripheral neuropathy and diabetic retinopathy. J Diabetes Complications. 2007 Sep-Oct;21(5):306-14. doi: 10.1016/j.jdiacomp.2006.08.002.
- Background: PubMed 15220233Gregg EW, Sorlie P, Paulose-Ram R, Gu Q, Eberhardt MS, Wolz M, Burt V, Curtin L, Engelgau M, Geiss L; 1999-2000 national health and nutrition examination survey. Prevalence of lower-extremity disease in the US adult population >=40 years of age with and without diabetes: 1999-2000 national health and nutrition examination survey. Diabetes Care. 2004 Jul;27(7):1591-7. doi: 10.2337/diacare.27.7.1591.
- Background: PubMed 24954624Albers JW, Pop-Busui R. Diabetic neuropathy: mechanisms, emerging treatments, and subtypes. Curr Neurol Neurosci Rep. 2014 Aug;14(8):473. doi: 10.1007/s11910-014-0473-5.
- Background: PubMed 9706126Boulton AJ, Malik RA. Diabetic neuropathy. Med Clin North Am. 1998 Jul;82(4):909-29. doi: 10.1016/s0025-7125(05)70029-8.
- BackgroundSoliman E,Gellido C.Diabetic Neuropathy. eMedicine.com March 29, 2002.
- Background: PubMed 30140138Ang L, Cowdin N, Mizokami-Stout K, Pop-Busui R. Update on the Management of Diabetic Neuropathy. Diabetes Spectr. 2018 Aug;31(3):224-233. doi: 10.2337/ds18-0036.
- Background: PubMed 15161806Boulton AJ, Malik RA, Arezzo JC, Sosenko JM. Diabetic somatic neuropathies. Diabetes Care. 2004 Jun;27(6):1458-86. doi: 10.2337/diacare.27.6.1458. No abstract available.
- Background: PubMed 15793206Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, Malik RA, Maser RE, Sosenko JM, Ziegler D; American Diabetes Association. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005 Apr;28(4):956-62. doi: 10.2337/diacare.28.4.956. No abstract available.
- Background: PubMed 21695763Dyck PJ, Albers JW, Andersen H, Arezzo JC, Biessels GJ, Bril V, Feldman EL, Litchy WJ, O'Brien PC, Russell JW; Toronto Expert Panel on Diabetic Neuropathy. Diabetic polyneuropathies: update on research definition, diagnostic criteria and estimation of severity. Diabetes Metab Res Rev. 2011 Oct;27(7):620-8. doi: 10.1002/dmrr.1226.
- Background: PubMed 9285500Thomas PK. Classification, differential diagnosis, and staging of diabetic peripheral neuropathy. Diabetes. 1997 Sep;46 Suppl 2:S54-7. doi: 10.2337/diab.46.2.s54.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambroxol Oral Product in people with Diabetic Neuropathy Peripheral, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beshoy Thabet, Bachelor of Pharmacy (+20 1111058017, beshoy.thabit@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Ambroxol on Tumor necrosis factor alpha (TNF-α) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558878, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.