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Clinical Study of Zandu Junior balm and market preparation in relieving symptoms of cold in Children

A randomized multicenter Clinical Study to evaluate efficacy and safety of Zandu Junior balm and market preparation in relieving symptoms in Children - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005707
Enrollment
100
Registered
2015-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J984- Other disorders of lung

Interventions

Intervention1: Zandu Junior Gel Balm: contains herbs such as Peppermint/Menthol (Mentha Sp.), Gaultheria/winter green oil (Gaultheria fragrantissima), Karpura/Camphor (Cinnamomum camphora), Lavang/Clo

Sponsors

Emami Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Willing to provide informed consent to participate in the study •Males or females Child 04-12 years of age both inclusive. •Diagnosis of Mild to Moderate Headache, Body ache and other symptoms of cough cold.

Exclusion criteria

Exclusion criteria: •Subjects having persistent headache, body ache or other symptoms which in the opinion of the investigator require proper medical diagnosis and management •Subjects who have associated moderate to high fever and those who require rescue medicines like analgesics •Immuno compromised children •Children allergic to application of products similar to test product.

Design outcomes

Primary

MeasureTime frame
Assessment of efficacy of Junior balm in relieving symptoms such as headache, Body ache, and symptoms of common cold like Nasal congestion, sore throat etc. based on VAS and Graded scaleTimepoint: Day 0, Day 2, Day 5 and Day 7

Secondary

MeasureTime frame
1. Assessment of efficacy of Zandu junior Gel Balm in comparison with market preparation in relieving headache, body ache, nasal congestion, sore throat etc. 2. Assessment of number of subjects having relief from symptoms on graded scale 3. Assessment of requirement of rescue medicines 4. Assessment of time taken for relief in the symptoms 5. Global assessment for overall improvement by the investigator and subject 6. Assessment of safetyTimepoint: Day 0, Day 2, Day 5 and Day 7

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026