| CTRI Number |
CTRI/2025/03/083491 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
pH change and Salivary Clearance Rate Of Different Antitussive Lozenges In Adults |
|
Scientific Title of Study
|
pH Modulation And Salivary Clearance Rate Of Different Antitussive Lozenges In Adults: A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saloni Wankhede |
| Designation |
PG Student |
| Affiliation |
JMFs ACPM Dental College Dhule |
| Address |
Department of Public Health dentistry Room no 8 third floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule Dhule MAHARASHTRA 424001 India
Dhule
MAHARASHTRA
424001
India |
| Phone |
9307139321 |
| Fax |
|
| Email |
saloniwankhede9096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Vishwakarma |
| Designation |
Professor |
| Affiliation |
JMFs ACPM Dental College Dhule |
| Address |
Department of Public Health dentistry Room no 8 third floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule Dhule MAHARASHTRA 424001 India
Dhule
MAHARASHTRA
424001
India |
| Phone |
9766745627 |
| Fax |
|
| Email |
dr_prashanthvk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saloni Wankhede |
| Designation |
PG Student |
| Affiliation |
JMFs ACPM Dental College Dhule |
| Address |
Department of Public Health dentistry Room no 8 third floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule Dhule MAHARASHTRA 424001 India
Dhule
MAHARASHTRA
424001
India |
| Phone |
9307139321 |
| Fax |
|
| Email |
saloniwankhede9096@gmail.com |
|
|
Source of Monetary or Material Support
|
| JMFs ACPM Dental College dhule maharashtra India pin code 424001 |
|
|
Primary Sponsor
|
| Name |
Dr. Saloni Wankhede |
| Address |
JMFs ACPM Dental College Dhule Maharashtra India Pincode 424001 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saloni Wankhede |
Jawahar medical foundation annasaheb chudaman patil memorial dental college |
Departement OF Public Health Dentistry Room NO 8 Third Floor awaharal medical foundation annasaheb chudaman patil memorial dental college dhule
Dhule 424001
MAHARASHTRA
Dhule
MAHARASHTRA |
9307139321
saloniwankhede9096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Annasaheb Chaudam Patil Memorial Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Koflet Lozenges |
participants is asked to consume the lozenges for 1 min At the baseline before consumption of lozenges and after 5min 10 min 15 min 20min and 30 min of consumption the intrinsic pH salivary flow rate and oral clearance rate will be measured |
| Comparator Agent |
Strepsils Lozenges |
participants is asked to consume the lozenges for 1 min At the baseline before consumption of lozenges and after 5min 10 min 15 min 20min and 30 min of consumption the intrinsic pH salivary flow rate and oral clearance rate will be measured |
| Comparator Agent |
Tus Q Lozenges |
participants is asked to consume the lozenges for 1 min At the baseline before consumption of lozenges and after 5min 10 min 15 min 20min and 30 min of consumption the intrinsic pH salivary flow rate and oral clearance rate will be measured |
| Intervention |
vicks lozenges |
participants is asked to consume the lozenges for 1 min At the baseline before consumption of lozenges and after 5min 10 min 15 min 20min and 30 min of consumption the intrinsic pH salivary flow rate and oral clearance rate will be measured |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who were 18-22 years of age
Subjects who were caries-free that is with DMFT score 0
Subjects who were not suffering from any systemic disease or illness such as asthma or COPD were included in the study |
|
| ExclusionCriteria |
| Details |
Individuals who did not provide informed consent, Individual who had allergies to lozenge ingredients individul who were using other cough medications, or were pregnant or lactating were excluded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate The salivary pH
Salivary Oral clearance rate of different Antitussive Lozenges in adults |
5min 10min 15min 20min 30min after consumption of test food |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate The salivary pH
Salivary Oral clearance rate of different Antitussive Lozenges in adults |
5min 10min 15min 20min 30min after consumption of test food |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Anti-tussive lozenges are often consumed by individuals suffering from sore throat and upper respiratory tract infections due to their cough suppressant and soothing effect on the oro-pharynx. There is indiscriminate use of lozenges due to their easy availability and affordability. The active ingredients in most of these lozenges are amylmetacresol, dichlorobenzyl alcohol and/or dextromethorphan and they impart an unpleasant taste. In order to make the lozenges palatable, large amounts of sugars are added to them. Besides sugars, these lozenges also contain acids that contribute to their inherent pH. Hence the present study is conducted To compare the salivary pH and oral sugar clearance of 4 different commercially available Anti-tussive lozenges. Methodology: Forty subjects aged 18-35 years were selected randomly. Four different commercially available anti-tussive lozenges Vicks, Strepsils, Koflets, Tus Q were given to subject. Salivary pH values and salivary sugar clearance rates are assessed at baseline before the consumption of lozenges and then 5, 10, 15, 20, and 30 min after consumption. |