A study to evaluate the efficacy and safety of THROZEN (Cough Drop Formulation) for the treatment of cough and sore throat.

Phase 2/3

Completed

• Conditions: Cough, Sore Throat, Dry mouth, Itching of Throat, Voice Quality, Redness of throat, Hoarseness; Other diseases of the respiratory system,

• Registration Number: CTRI/2018/08/015547
• Lead Sponsor: MKTS Global Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-09
• Study Completion: 2018-11-29
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief from soar throat and cough	14 days intervention study

Secondary Outcome Measures

Name	Time	Method
Relief from nasal congetion	14 days intervention study

Trial Locations

Locations (2)

Dr Anand Kotecha Clinic; 🇮🇳 Rajkot, GUJARAT, India

Dr Satej Patel Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Dr Anand Kotecha Clinic

🇮🇳Rajkot, GUJARAT, India

Dr Anand Kotecha

Principal investigator

9998521558

dranandkotecha@gmail.com