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CTRI Number  CTRI/2020/03/023788 [Registered on: 05/03/2020] Trial Registered Prospectively
Last Modified On: 25/11/2020
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Treatment of dry or productive cough 
Scientific Title of Study   Multi-centric, Open label, Single arm, Clinical Study to Evaluate the Efficacy and Safety of Kafnorm® Syrup for Symptomatic Relief of Dry or Productive Cough. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narsinh M Patel 
Designation  BAMS (Physician and Surgeon) 
Affiliation  Sanjeevani Heart And Medical Hospital 
Address  Dr. N.M. Patel Clinic, Gayatri nagar-3, Chandlodiya, Ahmedabad
Opp :, Sanjeevani Complex, Nava Wadaj Rd, Mahesana Society, Sardar Colony, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT
382481
India 
Phone  8000445716  
Fax    
Email  dr.patelnm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narsinh M Patel 
Designation  BAMS (Physician and Surgeon) 
Affiliation  Sanjeevani Heart And Medical Hospital 
Address  Dr. N.M. Patel Clinic, Gayatri nagar-3, Chandlodiya, Ahmedabad
Opp :, Sanjeevani Complex, Nava Wadaj Rd, Mahesana Society, Sardar Colony, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT
382481
India 
Phone  8000445716  
Fax    
Email  dr.patelnm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Narsinh M Patel 
Designation  BAMS (Physician and Surgeon) 
Affiliation  Sanjeevani Heart And Medical Hospital 
Address  Dr. N.M. Patel Clinic, Gayatri nagar-3, Chandlodiya, Ahmedabad
Opp :, Sanjeevani Complex, Nava Wadaj Rd, Mahesana Society, Sardar Colony, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT
382481
India 
Phone  8000445716  
Fax    
Email  dr.patelnm@gmail.com  
 
Source of Monetary or Material Support  
Virgo UAP Pharma Pvt Ltd 
 
Primary Sponsor  
Name  Virgo UAP Pharma Pvt 
Address  Virgo UAP Pharma Pvt. Ltd ,Mahagujarat Industrial Estate, Plot No. 423/98B, Sarkhej-Bavla Highway, Village Moraiya, Taluka-Sanand, Ahmedabad - 382213 , Gujarat , India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr NM Patel  Dr. N.M. Patel Clinic  Clinical Trial Department,Dr. N.M. Patel Clinic, Gayatri Nagar-3, Chandlodiya, Ahmedabad
Ahmadabad
GUJARAT 		 8000445716

dr.patelnm@gmail.com 
Dr Heena Patel  Sanjeevani Heart and Medical Hospital  Sanjeevani Heart and Medical Hospital, Near Devasya Clinic, Opposite Mehsana Society, Vadaj, Ahmedabad
Ahmadabad
GUJARAT 		 7927641742
0
drheenapatel26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committe Sanjeevani Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kafnorm Syrup  Relief from dry or productive cough Route of administration: oral Frequency:10 mLThrice a day Dose:10mL 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Age 18−50 completed years.
2. History of acute dry or productive cough ≤ 1-week duration.
3. Cough score of 0,1,2 as per day time cough scale.
4. Willing to give written informed consent.
5. Able to comply with study requirements.
6. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
7. Patient willing to refrain from smoking, alcohol, etc. 
 
ExclusionCriteria 
Details  1. Age < 18 years.
2. Pregnant (as per urine pregnancy test) or lactating female patient.
3. Past history of drug abuse and alcohol consumption since last 6 months.
4. Symptoms of the cough for more than 1 week.
5. Known immune deficiency.
6. Lung disease (include asthma or COPD).
7. Other respiratory disorders like Tuberculosis, chronic bronchitis, asthma, suspected pneumonia, suspected bacterial infections etc.
8. History / current condition of Cardiac disease like cardiomegaly, myocardial infraction, mitral regurgitation etc.
9. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain or diarrhea.
10. Difficulty in filling in the patient diary.
11. History of uncontrolled Diabetes Mellitus.
12. Current smoker, Smoking history >10 packs per month.
13. Patient who received other medications and antibiotic (give all details) for cough within 3 days prior to Investigation drug administration.
14. History of or patients taking any medication that causes cough.
15. History of homemade therapy and patient not willing to refrain from such medications, therapy, home-made therapy during the treatment phase.
16. Patient agreed to avoid such condition like certain foods like cold foods, cold drinks, cough induced lifestyle and cold environmental conditions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in day and night frequencies of cough: [Time
frame: Baseline/Screening & 1, 2 & 3 days post-treatment]
– Will be evaluated on 6 point scale in treated patient. 1. Change in throat irritation: [Time frame:
Baseline/Screening & 1, 2 & 3 days post-treatment] – Will
be evaluated on 6 point scale. 		 5 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of relief from symptoms
2. Time to relief from cough and throat irritation
3. Physician’s global assessment of efficacy 		 5 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   09/03/2020 
Date of Study Completion (India) 20/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/10/2020 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 Multi-centric, Open-label, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Kafnorm® Syrup for Symptomatic Relief of Dry or Productive Cough.

Primary Objectives: To evaluate the clinical efficacy of Kafnorm® syrup for symptomatic relief of dry or productive cough.
Secondary Objectives: To assess the safety and tolerability of Kafnorm® syrup for symptomatic relief of dry or productive cough.
 
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