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CTRI Number  CTRI/2020/01/022659 [Registered on: 08/01/2020] Trial Registered Prospectively
Last Modified On: 06/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Panchakarma]  
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of Acute Coughing and Throat Irritation 
Scientific Title of Study   An open label clinical trial to evaluate the Efficacy of Kuka Cough Syrup in the Patients Suffering with Kasa (Acute Cough and Throat Irritation) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NOT REGISTERED ELSEWHERE  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gopesh Mangal  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda 
Address  Associate Professor P.G Dept. of Panchkarma N.I.A., Jaipur
Jowarar Singh Gate, Amer Road Jaipur, Raj
Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Himanshu Shekhar Tiwari 
Designation  Medical Advisor Multani Pharmaceuticals Ltd 
Affiliation  Multani Pharmaceuticals Ltd. New Delhi 
Address  Medical Advisor room, Pharmacy Division, Multani Pharmaceuticals Ltd. New Delhi
Multani Pharmaceuticals Ltd. New Delhi
New Delhi
DELHI
110020
India 
Phone  9654350714  
Fax    
Email  dr.hstiwari@multani.org  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Kumar 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda 
Address  Dept of Rasa Shastra and Bhaishajya Kalpana NIA, Jaipur
Jowarar Singh Gate, Amer Road Jaipur, Raj
Jaipur
RAJASTHAN
302002
India 
Phone  9887644272  
Fax    
Email  drsan_agr@yahoo.com  
 
Source of Monetary or Material Support  
Multani Pharmaceuticals 
 
Primary Sponsor  
Name  Multani Pharmaceuticals Ltd 
Address  Multani Pharmaceuticals Ltd, New Delhi. Address: T-10 Okhla Phase II Road, Pocket W. Okhla Industrial Area New Delhi- 110020  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gopesh Mangal  National Institute of Ayurveda  OPD No. 2(Panchakarma), National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Raj.
Jaipur
RAJASTHAN 		 8619849011

gmangal108@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Ayurveda IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kuka Cough Syrup  Ingredients: Tulsi (Occimum sanctum), Vasaka (Adhatoda vasica), Kulanjana (Alpinia galangal), Yastimadhu (Glycyrrhiza glabra), Pippali (Piper longum) and Sat Pudina (Menthol) Dose, Frequecny and Duration-10 ml (2 tsf) Orally, four times a day, before meals, with lukewarm water for 7 days. 
Comparator Agent  Not Applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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;

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
VCD scale   Day 0 and 7 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/01/2020 
Date of Study Completion (India) 21/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   It is an open label, single armed, single center, prospective, interventional clinical study to evaluate the efficacy of Kuka cough syrup in the patients suffering from acute cough and throat irritation. This study will be conducted in Panchakarma Department, NIA, Jaipur, Rajasthan. It will be advised to subjects to take the syrup four times a day for 7 days. The primary outcome measure will be to assess the efficacy of Kuka cough syrup in subjects with acute cough and throat irritation after 7 days of treatment. Time points will be Day 0 (Baseline), Day 3 and Day 7. Follow up of the subjects will be after 7 days, to check reoccurrence of the disease. 
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