A Phase 3 interventional study of zinc sulphate in Asthma in Children, sponsored by King Edward Medical University. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by King Edward Medical University · Phase 3, Interventional, and Treatment
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:
Group B (Control): Standard therapy only. Follow-Up \& Assessment All patients will be trained to maintain a diary, documenting responses to the
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 84 is close to the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →King Edward Medical University is the lead sponsor of 78 studies on the registry; 24 are open to participants now.
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Exclusion criteria
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
Drug: zinc sulphate
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
Drug: zinc sulphate
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
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: * Controlled- if ACT score ≥ 20 * Partially Controlled- if ACT score is 16-19 * Uncontrolled- if ACT score \< 16 The intervention will be considered effective if there is a statistically significant increase in ACT scores from baseline to 8 weeks.
Time frame: 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.
Time frame: Baseline, 4 weeks and 8 Weeks
Plan to share: No — Only the principal investigator, supervisor, and Institution Review Board will have access with patients data upon request
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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King Edward Medical University