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CTRI Number  CTRI/2023/09/058036 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 29/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of the herbal EMCOF cough syrup for cough control. 
Scientific Title of Study   A randomized, open label, interventional clinical study to assess the Efficacy and Safety of EMCOF cough syrup for the symptomatic treatment of acute and Chronic Productive and non-productive cough . 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EMCOF/14/23 version 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Sakthi Balan MD 
Designation  Consultant Diabetologist and CI  
Affiliation  Thirumalai medical Centre, ki3 
Address  Thirumalai Medical Centre, Roon no.1, Thirumalai Medical Centre, No 408 Cuddalore Road Nainarmandapam Puducherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan MD 
Designation  Consultant Diabetologist and CI  
Affiliation  Thirumalai medical Centre, ki3 
Address  Thirumalai Medical Centre, Roon no.1, Thirumalai Medical Centre, No 408 Cuddalore Road Nainarmandapam Puducherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar  
Designation  CEO 
Affiliation  KI3, CRO 
Address  KI3, Room No 1, KI3 Office, Regus Centre Level 2 Altius Block No 1, SIDCO Industrial Estate Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9003109416  
Fax    
Email  drgayathri@ki3services.com  
 
Source of Monetary or Material Support  
Medopharm, Medo House, 25, Puliyur 2nd Main Rd, Trustpuram, Kodambakkam, Chennai, Tamil Nadu 600024 
 
Primary Sponsor  
Name  Medopharm 
Address  No.25, Puliyur 2nd Main Road, Trustpuram Kodambakkam - 600024 TAMIL NADU, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Sakthi Balan  Thirumalai Medical Centre, Puducherry  Room no.1, Thirumalai Medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry Pondicherry PONDICHERRY
Pondicherry
PONDICHERRY 		 9443627722

saheerose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethique De La Nature Association  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  Group 1: For non Productive cough, Emcof Herbal Cough Syrup 5 ml thrice daily orally  1. Adhatoda vasica – 10mg 2. Solanum xanthocarpum – 25mg 3. Piper nigrum – 10mg 4. Zingiber officinate – 20mg 5. Glycyrrhiza glabra – 20mg 6. Emblica officinalis – 10mg 7. Curcuma longa – 25mg 8. Acacia catechu – 20mg 9. Ocimum sanctum – 10mg 10. Foeniculum vulgare – 20mg 11. Terminalia belerica – 10mg 12. Piper longum – 20mg 13. Pistacia integerrima – 10mg 14. Menthol – 1mg Given 5 ml thrice daily orally for 1 week 
Intervention  Group 2:FOr productive cough, Emcof Herbal Cough Syrup 5 ml thrice daily orally  given 5 ml thrice daily orally for 1 week 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients willing to provide written informed consent to participate in the study
2. Male and Female patient in the age range of 10-65 years.
3. Patients with acute and Chronic,Productive or non-productive cough (Dry cough, Wet cough, Asthmatic cough, Allergic cough, Infective cough, Smokers cough, Sore throat, Hoarse cough, Ratting / Tickling cough) presenting in out patient setting.
4. Patients with a baseline daytime cough symptom score of at least 2. 
 
ExclusionCriteria 
Details  1. Female patient who is pregnant or lactating.
2. Patients or with clinically suspected lower respiratory tract infection (e.g. pneumonia tuberculosis)
3. Patients taking any other antitussives, sleeping pills, sedative medications, or herbal cough remedies;
4. Patients currently on any treatments that may influence cough.
5. Patient has history of hepatic or renal insufficiency
6. History of hypersensitivity to any of the test products.
7. Any condition decided as unfit for study by Clinical investigator 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Change in the daytime cough symptom scores and cough rating scale at end of 5 days (120 hrs) of first examination as compared to the baseline
2. Change in Night time cough symptom scores and cough rating scale from the baseline to end of 5 days (120 hrs) of first examination as compared to the baseline
3. Reduction of pharyngeal(throat) pain(if present) before and at the end of 5 days- measured on Visual Analogue Scale (VAS) . [time frame: 5 days]
4. Use of rescue medication (Cough syrup). [time frame: 10 days]
5. Proportion of patients having a confirmed Best response or Partial Response or Complete response (10 days duration)
6. To assess the quality of life among the study participants using pre and post Study Leicester Cough Questionnaire (LCQ-acute)
Adverse events and serious adverse events during the study period
Brief clinical examination 		 Day 0, Day 2, Day 5 and Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
1)To demonstrate safety and tolerability of study product by Clinical AEs (If any)
2)Proportion of patients having a confirmed Best response or Partial Response Or Complete response (10 days duration)
3)To assess the quality of life among the study participants using
pre and post Study Leicester Cough Questionnaire (LCQ-acute) 		 Day 0, Day 2, Day 5 and Day 7 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/10/2023 
Date of Study Completion (India) 20/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 50 participants will be randomized in tos ingle group.Dosing will be done daily orally twice or thrice daily for 5-7 days. Subjects will be asked to visit clinical facility/ institution for their follow up at the end of day 2 , day 5 and day 7 and any other additional visits if needed.

Primary and Secondary Outcome

1) Change in daytime Cough symptom scores

2) Change in Night time Cough Symptom

3) Reduction of Pharyngeal pain

4) VAS Score

5) Proportion of patients having a confirmed Best Response or partial Response or Complete Response

6) To assess quality of Life using Leicestar Cough Questionnaire (LCQ-acute)


 
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