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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/04/005707
• Date of registration: 21-04-2015
• Prospective Registration: Yes
• Primary sponsor: Emami Limited
• Public title: Clinical Study of Zandu Junior balm and market preparation in relieving symptoms of cold in Children
• Scientific title: A randomized multicenter Clinical Study to evaluate efficacy and safety of Zandu Junior balm and market preparation in relieving symptoms in Children - NIL
• Date of first enrolment: 22-04-2015
• Target sample size: 100
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11529
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
• Phase: Phase 3/ Phase 4

Countries of recruitment

India

Contacts

• Name: Dr Sanjay Tamoli
• Affiliation: Target Institute of Medical Education and Research

• Name: Dr Sanjay Tamoli
• Affiliation: Target Institute of Medical Education and Research

Key inclusion & exclusion 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: •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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: J984- Other disorders of lung

Intervention(s)

Intervention1: Zandu Junior Gel Balm: contains herbs such as Peppermint/Menthol (Mentha Sp.), Gaultheria/winter green oil (Gaultheria fragrantissima), Karpura/Camphor (Cinnamomum camphora), Lavang/Clove (Syzygium aromaticum), Carum/Ajowan (Trachyspermum ammi), Nilgiri/Eucalyptus (Eucalyptus globules), Nutmeg (Myristica fragrans) and Marjoram (Origanum majorana) Dose: Subjectâ??s guardian / parents will be advised to apply sufficient quantity of Zandu Junior balm on forehead, nose, neck, and chest and back of children and massage gently twice daily for 7 days
Control Intervention1: Marketed Preparation: Dose: Subjectâ??s guardian / parents will be advised to apply sufficient quantity of Marketed Preparation on forehead, nose, neck, and chest and back of children and massage gently twice daily or 7 days

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

ZJB/E/01/2015, Version 1.0, 15th Jan 2015

Source(s) of Monetary Support

Emami Limited, A Wing 701 7th Floor Express Zone, Western Express Highway, Near Patel Engineering Diagonally opposite Oberio Mall, Goregaon (East) Mumbai-400 063

Ethics review

Status: Approved
Approval date: 03/03/2015
Contact:

Institutional Ethics Committee, Ayurved Seva Sanghâ??s, Ayurved Mahavidyalaya, Ganesh Wadi, Panchavati, Nasik

Status: Not Approved
Approval date:
Contact:

PDEA College Of Ayurved and Research Center, Sector 25, Pradhikaran, Nigdi, Pune 411044