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
|
|
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
|
|
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. |