Ayurvedic management of Acute Coughing and Throat Irritation

Phase 2

Completed

• Conditions: Acute upper respiratory infection,unspecified,

• Registration Number: CTRI/2020/01/022659
• Lead Sponsor: Multani Pharmaceuticals Ltd

Brief Summary

Itis an open label, single armed, single center, prospective, interventionalclinical study to evaluate the efficacy of Kuka cough syrup in the patientssuffering from acute cough and throat irritation. This study will be conductedin Panchakarma Department, NIA, Jaipur, Rajasthan. It will be advised tosubjects to take the syrup four times a day for 7 days. The primary outcomemeasure will be to assess the efficacy of Kuka cough syrup in subjects withacute cough and throat irritation after 7 days of treatment. Time points willbe Day 0 (Baseline), Day 3 and Day 7. Follow up of the subjects will be after 7days, to check reoccurrence of the disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study Completion: 2020-12-21
• Last Update Posted: 2021-06-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• History of acute nonproductive cough due to any cause.
• Subjects who are willing to give informed consent and ready to comply with the protocol.
• Subjects who are ready to provide regular follow up until the completion of the 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 required Any underlying lung pathology such as lung abscess or cystic fibrosis, individuals with a history of myocardial infarction within 4 weeks prior to enrollment;.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VCD scale	Day 0 and 7

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 in all the subjects, drowsiness, and Physician’s Global Assessment of efficacy evaluated at visit 4 in both the treatment groups on VCD scales	14 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