“Study of Kuka cough lozenges in Kasa (acute coughing and throat irritation)â€

Phase 2

Completed

• Conditions: Acute upper respiratory infection,unspecified,

• Registration Number: CTRI/2019/12/022588
• Lead Sponsor: Multani Pharmaceuticals Ltd

Brief Summary

The present research project is for a randomized clinical trial to evaluate the safety and efficacy of Kuka cough lozenges variants in the subjects suffering with acute cough and throat irritation proposed to be carried out at NIA, Jaipur. Kuka cough lozenges (KCL) has four variants which are KCL Tulsi orange, KCL Tulsi ginger, KCL Tulsi lemon and KCL Tulsi mint. **120** Subjects will be randomly recruited from the OPD NIA, Jaipur, who will fulfill the inclusion criteria and will willing and able to provide signed informed consent form (ICF) prior to the study initiation and will be divided into 4 Groups.

For each variant one group will be created and, 30 patients will be recruited in each group. Effect of the lozenges will assessed after 2 hours of administration on Day 1 and then on Day 3. Day 0 will be considered as baseline and effect of the therapy will be analyzed on the basis of it. Follow up of the subjects will be for 5 days for checking the recurrence of disease.

**Plan of analysis (analysis of data):** For statistical analysis of data ANOVA, wilcoxan test will be used to analyzed and compare the subjective measures.  P value <0.05 will be considered as significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Males and females with a history of acute cough due to any cause except those listed in exclusion criteria.
• Throat irritation for <1 week duration, who will be able to comply with the study requirements 3.
• Patients having a cough score of 0, 1 or 2 during day time (as per Day Time Cough Scale described under end points) 4.
• Patients willing and able to provide signed ICF prior to study.

Exclusion Criteria

• Participants with a history of acute lower respiratory tract infections such as pneumonia, bronchitis whooping cough, chronic obstructive pulmonary disease/asthma, tuberculosis, systemic bacterial infections for which specific drug therapy will be required; 2.
• Any underlying lung pathology such as lung abscess or cystic fibrosis 3.
• Individuals with a history of myocardial infarction within 4 weeks prior to enrollment; 4.
• Individuals with a history of Parkinson’s disease and who were on monoamine oxidase inhibitors.
• Individuals with any psychiatric illness which may impair the ability to provide written ICF.
• Individuals participating in any other clinical trial.
• Pregnant or lactating females.
• Those who are under study treatment or any other condition due to which individuals are deemed unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria 9.
• Alcohol, smoke, and drug abusers will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in day/night time cough scales and throat irritation will be evaluated over a period of 3 days from baseline on verbal category descriptive (VCD) scale scores	8 days

Secondary Outcome Measures

Name	Time	Method
Time to relief from cough and throat irritation for all the first morning doses, duration of relief from symptoms for all first morning doses, drowsiness, and Physician’s Global Assessment of efficacy evaluated at visit 4 in both the treatment groups on VCD scales	8 Days

Trial Locations

Locations (1)

National Institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Gopesh Mangal

Principal investigator

8619849011

gmangal108@gmail.com