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The objective of this study is to compare the effectiveness of zinc as an adjuvant to standard therapy versus standard therapy alone in children with moderate persistent asthma, as assessed by the Asthma Control Test, in terms of:
HYPOTHESIS Zinc as an adjuvant to standard therapy is more effective than standard therapy alone in managing moderate persistent asthma in children.
DESIGN OF STUDY This is a Randomized Controlled Trial. FOLLOW-UP PROTOCOL The patients will be evaluated at the beginning of the study and then followed up at four weeks and eight weeks after enrollment to assess the primary and secondary outcomes. PRIMARY OUTCOME To assess the improvement in asthma control based on the Asthma Control Test (ACT) score at 4 weeks and 8 weeks, respectively. SECONDARY OUTCOMES
To observe improvement in:
1. Children ( 5-10) years. 2. Either gender. 3.Patient diagnosed with asthma according to the operational definition 4.Child with acute exacerbation of asthma EXCLUSION CRITERIA
1. Demographic data will be collected. 2. A detailed history regarding symptoms, onset, duration of illness, progression, medication, level of asthma control, and general physical and systemic examination will be conducted. 3. Patients with moderate persistent asthma will be identified. 4. Using simple random sampling (lottery method), patients will be assigned into two groups:
Group A (Intervention): Standard therapy + Oral Zinc 20mg/day OD for 2 months.
Group B (Control): Standard therapy only. Follow-Up & Assessment All patients will be trained to maintain a diary, documenting responses to the
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| n Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months | Experimental | n Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months., all the patients of both groups will be trained to maintain diary regarding questionnaire asked in asthma control test, followed up 4 weekly for 8 weeks |
|
| n Group B will receive only Standard therapy. | Experimental | n Group B will receive only Standard therapy., all the patients of both groups will be trained to maintain diary regarding questionnaire asked in asthma control test, followed up 4 weekly for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinc sulphate | Drug | Group A (intervention) and Group B (non-intervention). The patients in Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months. While the patients in Group B will receive only Standard therapy. Then, all the patients of both groups will be trained to maintain diary regarding questionnaire asked in asthma control test, followed up 4 weekly for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control Test (ACT) Scores From Baseline to 8 Weeks | The effectiveness of zinc as an adjuvant to standard therapy in children with moderate persistent asthma will be assessed by changes in Asthma Control Test (ACT) scores. Scores will be categorized as:
The intervention will be considered effective if there is a statistically significant increase in ACT scores from baseline to 8 weeks. | Baseline, 4 weeks and 8 Weeks |
| Number of Emergency Visits Due to Asthma Exacerbation | The total number of emergency visits due to asthma exacerbation will be recorded at each follow-up. A reduction in emergency visits will be considered indicative of effective treatment. | Baseline, 4 weeks and 8 Weeks |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sadia Shabbir, MBBS,FCPS | Pediatrics Department King Edward Medical University Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Edward Medical University Lahore Pakistan | Lahore | Punjab Province | 05499 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29316003 | Result | King GG, James A, Harkness L, Wark PAB. Pathophysiology of severe asthma: We've only just started. Respirology. 2018 Mar;23(3):262-271. doi: 10.1111/resp.13251. Epub 2018 Jan 9. | |
| 29115880 | Result | Vijverberg SJH, Farzan N, Slob EMA, Neerincx AH, Maitland-van der Zee AH. Treatment response heterogeneity in asthma: the role of genetic variation. Expert Rev Respir Med. 2018 Jan;12(1):55-65. doi: 10.1080/17476348.2018.1403318. Epub 2017 Nov 21. |
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Only the principal investigator, supervisor, and Institution Review Board will have access with patients data upon request
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| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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Randamize clinical trial
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Double Blind
|
| 33274952 | Result | Siripornpanich S, Chongviriyaphan N, Manuyakorn W, Matangkasombut P. Zinc and vitamin C deficiencies associate with poor pulmonary function in children with persistent asthma. Asian Pac J Allergy Immunol. 2022 Jun;40(2):103-110. doi: 10.12932/AP-100620-0878. |
| 28058103 | Result | Rerksuppaphol S, Rerksuppaphol L. Zinc Supplementation in Children with Asthma Exacerbation. Pediatr Rep. 2016 Dec 9;8(4):6685. doi: 10.4081/pr.2016.6685. eCollection 2016 Nov 17. |
| 23312452 | Result | Khanbabaee G, Omidian A, Imanzadeh F, Adibeshgh F, Ashayeripanah M, Rezaei N. Serum level of zinc in asthmatic patients: a case-control study. Allergol Immunopathol (Madr). 2014 Jan-Feb;42(1):19-21. doi: 10.1016/j.aller.2012.07.008. Epub 2013 Jan 9. |
| 31685060 | Result | Chen M, Sun Y, Wu Y. Lower circulating zinc and selenium levels are associated with an increased risk of asthma: evidence from a meta-analysis. Public Health Nutr. 2020 Jun;23(9):1555-1562. doi: 10.1017/S1368980019003021. Epub 2019 Nov 5. |
| D007287 |
| Inorganic Chemicals |
| D017967 | Zinc Compounds |