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CTRI Number  CTRI/2016/09/007265 [Registered on: 09/09/2016] Trial Registered Prospectively
Last Modified On: 08/09/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Trial Study to Evaluate Efficacy and Safety of a Filmogen Glycerol Throat Spray containing CW-CYANIDIN Plant Premix 
Scientific Title of Study   A Comparative, Randomized, Double Blind, Parallel Group, Observational Clinical Trial Study to Evaluate Efficacy and Safety of a Filmogen Glycerol Throat Spray Containing Cw-Cyanidin Plant Premix Versus Saline Spray as Placebo in the treatment of patients Suffering from Wet (Productive) Cough  
Trial Acronym  Wet cough 
Secondary IDs if Any  
Secondary ID  Identifier 
NEX/HER-WET/OBS/2016, Version No.: 1.0, Dated: 13/May/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Bhatt 
Designation  President and CEO 
Affiliation  Nexus Clinical Research (India) Ltd 
Address  Nexus Clinical Research (India) Ltd 32A Nexus Centre For Clinical Excellence Shiravane Road,Service Industry, Sector 1, Mumbai Pune Highway, Nerul Navi Mumbai 400706, India

Mumbai
MAHARASHTRA
400706
India 
Phone  27714203  
Fax    
Email  hbo@nexuscro.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Bhatt 
Designation  President and CEO 
Affiliation  Nexus Clinical Research (India) Ltd 
Address  Nexus Clinical Research (India) Ltd 32A Nexus Centre For Clinical Excellence Shiravane Road,Service Industry, Sector 1, Mumbai Pune Highway, Nerul Navi Mumbai 400706, India


MAHARASHTRA
400706
India 
Phone  27714203  
Fax    
Email  hbo@nexuscro.com  
 
Source of Monetary or Material Support  
VitroBio ZAC de Lavaur, RCS Clemont-Fd, Siren 394 63500 Issoire, France  
 
Primary Sponsor  
Name  VITROBIO 
Address  VitroBio ZAC de Lavaur, RCS Clemont-Fd, Siren 394 63500 Issoire, France  
Type of Sponsor  Research institution 
 
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 Sarat Kumar Behera  Hi Tech Medical College & Hospital  Department of Medicine, Division of General Medicine, Second floor Room No. 01, Pandara Rasulgarh Bhubaneshwar Odisha 751025 Cuttack ORISSA
Cuttack
ORISSA 
09861252518

behera.saiprasanna82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hi Tech Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  For the Treatment of wet (productive) cough,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator: placebo product: 0.9% NaCl saline spray   Presentation: 30 ml aluminum container with a spray. Placebo product (sprays) will be presented identical to the Active Treatment test product except for the product code. The color of the bottle, spray, cover, and the sticker print will be identical for both Test and the Placebo sprays. Route of Administration: Oral  
Intervention  Test Product: A filmogen glycerol throat spray containing, Solagum, CW-Cyanidin plant premix & an essential oil  The product contains filmogen glycerol as the main active ingredient along with solagum, ChSp-W cyanidin plant premix (obtained from curcuma and Propolis) and an essential oil as excipient. Presentation: 30 ml aluminum container with a spray. Route of Administration: Oral  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Both male and female, Age between 08 to 65 years old.
Patients having acute moderate to severe wet (productive) cough (onset of bronchial mucus production at a maximum of 7 days prior to screening of any origin with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present).
Not under any antibacterial or antiviral treatment before recruitment.
Patients ready to abstain from using any drug (which will affect the study outcome) other than Investigational Product for the treatment of the studied condition during the study period except in cases if patient’s condition worsen (At the discretion of study physician antibiotic will be prescribed if required).
Ready to abstain from administration of any herbal or ayurvedic treatment or gargles directed to ease coughing or throat parameters, tea, coffee.
Cooperative and understanding skills.
 
 
ExclusionCriteria 
Details  Hypersensitivity/ history of allergy to any of the Investigational product’s components.
Those who had taken any medicated confectionary, throat pastille, spray, or any product with demulcent properties, expectorants, mucolytic drug, any cough medicines or drugs containing antihistamines within last 72 hours prior to screening and during study.
Participants with unproductive cough (dry cough)
Patients taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough
Patients with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
Patients who had used any local anesthetic within the past 24 hours.
Patients who have used a longer acting or slow release analgesic during the previous 24 hours.
Patients taking antibiotics during the previous 14 days.
Patients with a history of severe renal impairment, hepatic impairment.
Patients with a history of alcohol abuse or who stated that they regularly consume alcohol in excess of the recommended amounts (excessive alcohol greater than 21 units per week for females and greater than 28 units per week for males).
Patients unable to refrain from smoking during their stay in the investigative site.
Patient who is pregnant, nursing, or a woman of childbearing potential not practicing adequate contraception. Women, who are uncertain if they are pregnant, may participate in the study, if they undergo a pregnancy test, which shows a negative result.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change in the wet cough severity score
 
Two hours  
 
Secondary Outcome  
Outcome  TimePoints 
ï‚§ Change in the Chest discomfort score, Change in the color of expectorated sputum, Consistency of sputum, at 2h after the start of treatment on the day 1, day 2, day 3, day 6, day 9, day 12, day 15 or up to complete recovery (whichever is earlier) compared to baseline.  2h after the start of treatment on the day 1, day 2, day 3, day 6, day 9, day 12, day 15 or up to complete recovery (whichever is earlier) compared to baseline. 
ï‚§ Change in score of throat pain, throat irritation/itching, throat mucosa redness, fever at 5 minutes and 2 h after the 1st application on the day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to baseline.  2 h after the 1st application on the day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to baseline. 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A cough is the sudden expulsion of air from the passages of the respiratory tract. Coughing is one of the body’s protective mechanisms. It serves the purpose of keeping our respiratory system clear. Cough can be described as productive or wet cough (also known as a chesty or mucous cough because the throat is wet and the mucus try to expel contaminants from the upper airways) or dry cough  – also known as tickly cough because this cough does not produce mucus and is known as a non-productive cough and is usually associated with throat irritation.

Cough is often generated due to the infection and irritation of the upper respiratory tract leading to the damage of the throat mucosa cells. Cellular damage cause generation of dead cell debris and creates a favorable ground for bacterial growth triggering inflammatory cascade, irritation and throat pain. Consequently our body reacts to humidify the throat surface and to stop the pain & irritation.

Almost all the currently available treatments are either expectorants & mucolytics or antitussives (used for dry, tickly coughs and are directed to soothe the throat, suppressing the cough reflex), antihistaminic or anti-bacterial, usually chemical in nature and therefore they are not suitable to repair damaged throat surface (injury can’t heal in the presence of chemicals).  Plant drugs, and saline solutions are also poorly effective.

Vitrobio observed that that in spite of the high prevalence of wet cough, there is no bandage, dressing, drug or device able to neutralize or to minimize the concentration of these impurities on the throat surface so as to act on the cause of the origin of cough.

ChSp-W formulation is a natural, safe, non-irritant and easily applicable filmogen bandage which could be used as a bandage over the throat surface and is capable to clean the throat surface instantly due to its hypertonic osmotic properties 


This will be a comparative, randomized, double blind, parallel group, observational clinical trial study compared to Placebo. The study will begin with screening evaluation.

After screening, Patients satisfying all the inclusion criteria will be enrolled and randomly allocated in 2:1 ratio as per randomization schedule to receive test product or Comparator product (Placebo-0.9% NaCl saline solution spray). Block Randomization methodology will be employed for generating the list. Within the block the treatment will be distributed in the ratio of 2:1. 

This study is designed to get exploitable results in at least 42 patients in the test group and 21 patients in the Placebo group. The main endpoint being wet cough, the patients will be selected only if they are suffering from wet cough (less than 7 days prior to screening) of any origin with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present)

 
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