Chronic Obstructive Pulmonary DiseaseSyProNACNCT06377410
Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients
A study testing Syrup Prospan and N-Acetylcysteine in people with Chronic Obstructive Pulmonary Disease, run by National University of Malaysia at 2 sites in Malaysia.
Trial summary
As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Syrup Prospan and N-Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 May 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with documented post bronchodilator FEV1/FVC < 70 or <LLN
- Age 40 years and above
- Able to perform spirometry
- Participant with Stable COPD based on GOLD 2023 strategy
Who cannot join
- Diagnosis of other chronic lung diseases: Asthma, Asthma-COPD Overlap, Interstitial Lung Disease, Bronchiectasis, Lung Cancer
- Participants with contraindication for spirometry: recent cardiac complications, major surgery, severe advanced respiratory disease, or those with cognitively or neurologically impairment
- Hypersensitivity to acetylcysteine or any component of the formulation
- Hypersensitivity to dry powder ivy extract
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
- Participant on pre-existing regular mucolytics (at least 1 month prior)
- Illiterate participants
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites, 2 recruiting
- Recruiting
National University of Malaysia, Faculty of Medicine
Cheras, Kuala Lumpur, 56000
Mohamed Faisal Abdul Hamid, 0391455555, faisal.hamid@ppukm.ukm.edu.my
- Not yet recruiting
National University of Malaysia
Cheras, Kuala Lumpur, 56000
Mohamed Faisal Abdul Hamid, MBBS (IIUM), 0391455555, faisal.hamid@ppukm.ukm.edu.my
About this study
Official title: A Randomised, Open Label, Interventional Study Evaluating the Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients (SyProNAC Trial)
As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial.
Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation.
Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency .
Read the detailed description
Hypothesis
- Syrup Prospan is non inferior to NAC - no significant difference of cough symptoms and its impact on daily activities, health related quality of life, as well as lung function test at 30 days of treatment
- Patients received Syrup Prospan has higher satisfaction score compared to N-Acetylcysteine
This is a randomised, open label, interventional study evaluating the efficacy and safety of dry powder Ivy Extract (Syrup Prospan) versus NAC among COPD patients. Randomization 1:1 to received either N.Acetylcysteine 600 mg BD or Syrup Prospan 7.5mls BD (Block randomization)
The study will be conducted from April 2024 to November 2026 This is a prospective interventional study conducted on COPD patients under the Respiratory Unit, Department of Internal Medicine in HCTM, who qualified both the inclusion and exclusion criteria. Patients will be briefed about this study.
Subsequently, consent will be obtained from those who are agree to participate from the patient him/herself.
Participants' will be assessed first with several modalities particularly spirometry, CAT score, McGill COPD Quality of Life and Cough and Sputum Assessment Questionnaire (CASA-Q) prior to the commencement of treatment.Participants will be seen on Day 15 to evaluate patients' adherence, compliance as well as adverse effect. Then patients will be assessed again on Day 30 of treatment with the same set of evaluation tools as in the beginning of the study.
In order to calculate the required sample size, we will employ the Cohen's d formula for estimating the effect size (Cohen, 1988) [19]. The formula is given as
Where d is the Cohen's effect size, M1 and M2 are the mean for the first and second group, and SD1 and SD2 are the standard deviation for the first and second group respectively.
Based on a previous study which employs the CAT score to assess the efficacy of NAC in patients with COPD, the mean and standard deviation for before and after treatment are given as:
Before treatment: 23.46 ± 3.66 After treatment: 20.38 ± 5.78
Hence, this give the values of M1 = 23.46 and M2 = 20.38, and SD1 =3.66 and SD2 = 5.78 that can use to estimate the effect size using the formula above.
Therefore, it gives an estimated effect size of 0.637 which is considered to be a medium effect size.
With a power of 80% and a level of significance of 5% for detecting an effect size of 0.637, we calculate the required sample size using an online sample size calculator for comparing paired differences. It gives at a value of 23 participants for each group which mean the required number of participants is 46.
Additional of 20% samples is recruited to avoid missing data due to withdrawal or drop out. Therefore, a total of minimum 55 patients will be recruited for this study. However, we aim to recruit 100 patients for our study where the treatment is given to equal number of participants in each group.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Syrup Prospan, N-Acetylcysteine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syrup ProspanDrug
Participant with stable COPD who received Syrup prospan for 1 month
N-AcetylcysteineDrug
Participant with stable COPD who received N-Acetylcysteine for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Participant with stable COPD who received Syrup prospan | Active comparator | Participant who fulfiled inclusion criteria with stable COPD and received Syrup prospan for 1 month Receives: Drug: Syrup Prospan |
| Participant with stable COPD who received N-Acetylcysteine | Active comparator | Participant who fulfiled inclusion criteria with stable COPD and received SN-Acetylcysteine for 1 month Receives: Drug: N-Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Measured: From the time of randomization to the time of the end of study up to 30 days post randomization
Secondary outcomes (6)
to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life.
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Measured: From the time of randomization to the time of the end of study up to 30 days post randomization
to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Measured: From the time of randomization to the time of the end of study up to 30 days post randomization
to determine change of Forced Vital Capacity in litres/minute using spirometry
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Measured: From the time of randomization to the time of the end of study up to 30 days post randomization
to determine adverse effects of Syrup Prospan (in %)
Participants with COPD who received Syrup Prospan
Measured: From the time of randomization to the time of the end of study up to 30 days post randomization
to determine adverse effects of N-Acetylcysteine (in %)
Participants with COPD who received N-Acetylcysteine
Measured: From the time of randomization to the time of the end of study up to 30 days post randomization
To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied)
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
Measured: From the time of randomization to the time of the end of study up to 30 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Faisal Abdul Hamid, MBBS (IIUM), Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377410
- Sponsor's protocol ID
- FF-2023-433
- Acronym
- SyProNAC
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2017 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1859-1922. doi: 10.1016/S0140-6736(18)32335-3.
PubMed 30415748Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. doi: 10.2147/copd.s3385. Epub 2009 Jun 11.
PubMed 19554195Donaldson GC, Wedzicha JA. COPD exacerbations .1: Epidemiology. Thorax. 2006 Feb;61(2):164-8. doi: 10.1136/thx.2005.041806.
PubMed 16443707Donaldson GC, Law M, Kowlessar B, Singh R, Brill SE, Allinson JP, Wedzicha JA. Impact of Prolonged Exacerbation Recovery in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):943-50. doi: 10.1164/rccm.201412-2269OC.
PubMed 26151174Garrard J, Rolnick SJ, Nitz NM, Luepke L, Jackson J, Fischer LR, Leibson C, Bland PC, Heinrich R, Waller LA. Clinical detection of depression among community-based elderly people with self-reported symptoms of depression. J Gerontol A Biol Sci Med Sci. 1998 Mar;53(2):M92-101. doi: 10.1093/gerona/53a.2.m92.
PubMed 9520914Poole P, Sathananthan K, Fortescue R. Mucolytic agents versus placebo for chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2019 May 20;5(5):CD001287. doi: 10.1002/14651858.CD001287.pub6.
PubMed 31107966Du Y, Wolf IK, Zhuang W, Bodemann S, Knoss W, Knopf H. Use of herbal medicinal products among children and adolescents in Germany. BMC Complement Altern Med. 2014 Jul 2;14:218. doi: 10.1186/1472-6882-14-218.
PubMed 24988878Balsamo R, Lanata L, Egan CG. Mucoactive drugs. Eur Respir Rev. 2010 Jun;19(116):127-33. doi: 10.1183/09059180.00003510.
PubMed 20956181
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open Label, Interventional Study Evaluating the Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients (SyProNAC Trial)
- ClinicalTrials.gov ID
- NCT06377410
- Acronym / sponsor ID
- SyProNAC / FF-2023-433
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Apr 2024 (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.
As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial.
Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation.
Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency .
Detailed description
Hypothesis
- Syrup Prospan is non inferior to NAC - no significant difference of cough symptoms and its impact on daily activities, health related quality of life, as well as lung function test at 30 days of treatment
- Patients received Syrup Prospan has higher satisfaction score compared to N-Acetylcysteine
This is a randomised, open label, interventional study evaluating the efficacy and safety of dry powder Ivy Extract (Syrup Prospan) versus NAC among COPD patients. Randomization 1:1 to received either N.Acetylcysteine 600 mg BD or Syrup Prospan 7.5mls BD (Block randomization)
The study will be conducted from April 2024 to November 2026 This is a prospective interventional study conducted on COPD patients under the Respiratory Unit, Department of Internal Medicine in HCTM, who qualified both the inclusion and exclusion criteria. Patients will be briefed about this study.
Subsequently, consent will be obtained from those who are agree to participate from the patient him/herself.
Participants' will be assessed first with several modalities particularly spirometry, CAT score, McGill COPD Quality of Life and Cough and Sputum Assessment Questionnaire (CASA-Q) prior to the commencement of treatment.Participants will be seen on Day 15 to evaluate patients' adherence, compliance as well as adverse effect. Then patients will be assessed again on Day 30 of treatment with the same set of evaluation tools as in the beginning of the study.
In order to calculate the required sample size, we will employ the Cohen's d formula for estimating the effect size (Cohen, 1988) [19]. The formula is given as
Where d is the Cohen's effect size, M1 and M2 are the mean for the first and second group, and SD1 and SD2 are the standard deviation for the first and second group respectively.
Based on a previous study which employs the CAT score to assess the efficacy of NAC in patients with COPD, the mean and standard deviation for before and after treatment are given as:
Before treatment: 23.46 ± 3.66 After treatment: 20.38 ± 5.78
Hence, this give the values of M1 = 23.46 and M2 = 20.38, and SD1 =3.66 and SD2 = 5.78 that can use to estimate the effect size using the formula above.
Therefore, it gives an estimated effect size of 0.637 which is considered to be a medium effect size.
With a power of 80% and a level of significance of 5% for detecting an effect size of 0.637, we calculate the required sample size using an online sample size calculator for comparing paired differences. It gives at a value of 23 participants for each group which mean the required number of participants is 46.
Additional of 20% samples is recruited to avoid missing data due to withdrawal or drop out. Therefore, a total of minimum 55 patients will be recruited for this study. However, we aim to recruit 100 patients for our study where the treatment is given to equal number of participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant with stable COPD who received Syrup prospan | Active comparator | Drug: Syrup ProspanParticipant who fulfiled inclusion criteria with stable COPD and received Syrup prospan for 1 month |
| Participant with stable COPD who received N-Acetylcysteine | Active comparator | Drug: N-AcetylcysteineParticipant who fulfiled inclusion criteria with stable COPD and received SN-Acetylcysteine for 1 month |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with documented post bronchodilator FEV1/FVC < 70 or <LLN
- Age 40 years and above
- Able to perform spirometry
- Participant with Stable COPD based on GOLD 2023 strategy
Key exclusion criteria (7 listed)
- Diagnosis of other chronic lung diseases: Asthma, Asthma-COPD Overlap, Interstitial Lung Disease, Bronchiectasis, Lung Cancer
- Participants with contraindication for spirometry: recent cardiac complications, major surgery, severe advanced respiratory disease, or those with cognitively or neurologically impairment
- Hypersensitivity to acetylcysteine or any component of the formulation
- Hypersensitivity to dry powder ivy extract
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
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 |
|---|---|---|
| Syrup ProspanParticipant with stable COPD who received Syrup prospan for 1 month | Drug | Participant with stable COPD who received Syrup prospan |
| N-AcetylcysteineParticipant with stable COPD who received N-Acetylcysteine for 1 month | Drug | Participant with stable COPD who received N-Acetylcysteine |
Primary outcome
To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.
Time frame: From the time of randomization to the time of the end of study up to 30 days post randomization
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
6 secondary outcomes
to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life.
Time frame: From the time of randomization to the time of the end of study up to 30 days post randomization
to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry
Time frame: From the time of randomization to the time of the end of study up to 30 days post randomization
to determine change of Forced Vital Capacity in litres/minute using spirometry
Time frame: From the time of randomization to the time of the end of study up to 30 days post randomization
to determine adverse effects of Syrup Prospan (in %)
Time frame: From the time of randomization to the time of the end of study up to 30 days post randomization
to determine adverse effects of N-Acetylcysteine (in %)
Time frame: From the time of randomization to the time of the end of study up to 30 days post randomization
To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied)
Time frame: From the time of randomization to the time of the end of study up to 30 days post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 30415748GBD 2017 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1859-1922. doi: 10.1016/S0140-6736(18)32335-3.
- Results publication: PubMed 19554195Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. doi: 10.2147/copd.s3385. Epub 2009 Jun 11.
- Results publication: PubMed 16443707Donaldson GC, Wedzicha JA. COPD exacerbations .1: Epidemiology. Thorax. 2006 Feb;61(2):164-8. doi: 10.1136/thx.2005.041806.
- Results publication: PubMed 26151174Donaldson GC, Law M, Kowlessar B, Singh R, Brill SE, Allinson JP, Wedzicha JA. Impact of Prolonged Exacerbation Recovery in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):943-50. doi: 10.1164/rccm.201412-2269OC.
- Results publication: PubMed 9520914Garrard J, Rolnick SJ, Nitz NM, Luepke L, Jackson J, Fischer LR, Leibson C, Bland PC, Heinrich R, Waller LA. Clinical detection of depression among community-based elderly people with self-reported symptoms of depression. J Gerontol A Biol Sci Med Sci. 1998 Mar;53(2):M92-101. doi: 10.1093/gerona/53a.2.m92.
- Results publication: PubMed 31107966Poole P, Sathananthan K, Fortescue R. Mucolytic agents versus placebo for chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2019 May 20;5(5):CD001287. doi: 10.1002/14651858.CD001287.pub6.
- Results publication: PubMed 24988878Du Y, Wolf IK, Zhuang W, Bodemann S, Knoss W, Knopf H. Use of herbal medicinal products among children and adolescents in Germany. BMC Complement Altern Med. 2014 Jul 2;14:218. doi: 10.1186/1472-6882-14-218.
- Results publication: PubMed 20956181Balsamo R, Lanata L, Egan CG. Mucoactive drugs. Eur Respir Rev. 2010 Jun;19(116):127-33. doi: 10.1183/09059180.00003510.
- 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.
Mohamed Faisal Abdul Hamid, MBBS (IIUM) principal investigator
National University of Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syrup Prospan and N-Acetylcysteine in people with Chronic Obstructive Pulmonary Disease, run by National University of Malaysia at 2 sites in Malaysia.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Faisal Abdul Hamid, MBBS (IIUM) (0391455555, faisal.hamid@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact. (time frame: From the time of randomization to the time of the end of study up to 30 days post randomization). 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 NCT06377410, which also lists 8 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 19 Nov 2025.