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CTRI Number  CTRI/2018/08/015547 [Registered on: 30/08/2018] Trial Registered Prospectively
Last Modified On: 21/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   A study to evaluate the efficacy and safety of THROZEN (Cough Drop Formulation) for the treatment of cough and sore throat. 
Scientific Title of Study   A Single -blind, Randomized, Clinical Study of THROZEN (Cough Drop Formulation) for the treatment of cough and sore throat 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rina H Gokani 
Designation  Director and CSO 
Affiliation  Accuprec Research Labs Pvt Ltd 
Address  Opp Zydus Pharmez Changodar bavla highway Nr Matoda patia

Ahmadabad
GUJARAT
382213
India 
Phone  9099616769  
Fax    
Email  rina.gokani@accuprec.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rina H Gokani 
Designation  Director and CSO 
Affiliation  Accuprec Research Labs Pvt Ltd 
Address  Opp Zydus Pharmez Changodar bavla highway Nr Matoda patia

Ahmadabad
GUJARAT
382213
India 
Phone  9099616769  
Fax    
Email  rina.gokani@accuprec.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manish A Rachchh 
Designation  Director and CEO 
Affiliation  Accuprec Research Labs Pvt Ltd 
Address  Opp Zydus Pharmez Changodar bavla highway Nr Matoda patia

Ahmadabad
GUJARAT
382213
India 
Phone  9099981023  
Fax    
Email  manish.rachchh@accuprec.com  
 
Source of Monetary or Material Support  
M K T S Global Pvt Ltd 805 RemiCommercio Plot no 14 Shah Industrial Estate Off Veera Desai Road Andheri West Mumbai 400053  
 
Primary Sponsor  
Name  MKTS Global Pvt Ltd 
Address  805 RemiCommercio Plot no 14 Shah Industrial Estate Off Veera Desai Road Andheri West Mumbai400053  
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 Anand Kotecha  Dr Anand Kotecha Clinic  Jagannath Chowk Off Kalawad Road 360005
Rajkot
GUJARAT 
9998521558

dranandkotecha@gmail.com 
Dr Satej Patel  Dr Satej Patel Clinic  C8 Suvas Apartment BH Avenue Bunglow Thaltej 380059
Ahmadabad
GUJARAT 
9904794904

drsatejpatel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Cough, Sore Throat, Dry mouth, Itching of Throat, Voice Quality, Redness of throat, Hoarseness 
Patients  (1) ICD-10 Condition: J96-J99||Other diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  THROZEN cough drop  It is a herbal cough drop comprising Anacyclus pyrethrum, zinc and menthol. Dose: One cough drop twice a day. Administration : Oral Total duration of Therapy: Two weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Human volunteers with cough and/or sore throat issues should be included
Patient with sign and symptoms of viral or bacterial throat infection
Patients between the age above 18 to 65 years from both sex
Patients willing to sign an informed written consent and comply with visit schedules
Patients must be able to communicate effectively with study personnel
 
 
ExclusionCriteria 
Details  Known positive status and known history for HIV, active hepatitis B or hepatitis C.
Pregnant or breast feeding women
Volunteers should not have any disease. Especially respiratory tract disorder and tuberculosis volunteers even with past historyshould not be included
Subjects on any other experimental treatment within 07 days of the first dose of study drug or who have not recovered from the side effects of such therapy
Patient have history of hospitalized treatment before 07 days
Patient taking any other then investigational drug in last 07 days
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Relief from soar throat and cough  14 days intervention study 
 
Secondary Outcome  
Outcome  TimePoints 
Relief from nasal congetion  14 days intervention study 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/09/2018 
Date of Study Completion (India) 29/11/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/11/2018 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The Clinical trial of THROZEN Cough drops completed successfully. In Single-blind, Randomized, Clinical Study of THROZEN (Cough Drop Formulation), total numbers of patients screened were 230 and numbers of subjects enrolled for the study were 108. The Subjects were given the cough drop after they were enrolled in the study and were followed up for a period of fourteen days. There were two follow-up visits on day 07 and day 14.  The Cough and Sore throat severity, Dry mouth, Itching of throat, Voice quality, Redness of throat and Hoarseness were recorded during follow-up visits. 08 subjects discontinued after 07 days of study willingly. All the subjects studied showed a significant decrease in the frequency and severity of the cough and sore throat. No any adverse effects observed. If there are less intense symptoms, subjects have shown cure within 07 days course also. Assessment was based on improvement in symptoms, acceptability and overall efficiency and safety as reported by the physician and the subjects. Subjects showed positive response during the treatment period and the effects of cough drops are found satisfactory. The test drug THROZEN proved to be an effective and safe cough drop and highly acceptable for subjects with cough and sore throat. Thus, Throzen is clinically proven for its efficacy and safety.

 
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