| CTRI Number |
CTRI/2025/07/090358 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effects of Jasmate® Mouthwash in spray form and Biotene® oral Gel in managing pain in patients suffering with burning mouth conditions |
|
Scientific Title of Study
|
Comparative evaluation of Jasmate® Mouthwash and Biotene® Gel in burning mouth conditions- 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 Sunil Surendraprasad Mishra |
| Designation |
Professor and Head |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9890515247 |
| Fax |
|
| Email |
aegisthesunil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Surendraprasad Mishra |
| Designation |
Professor and Head |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune-411018
MAHARASHTRA
411018
India |
| Phone |
9890515247 |
| Fax |
|
| Email |
aegisthesunil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Surendraprasad Mishra |
| Designation |
Professor and Head |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune-411018
MAHARASHTRA
411018
India |
| Phone |
9890515247 |
| Fax |
|
| Email |
aegisthesunil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jasberry Healthcare Private Limited,
Booth No. 78, Urban Estate, Gol Market, Kapurthala, Punjab 144601 INDIA |
|
|
Primary Sponsor
|
| Name |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune-18 |
| Type of Sponsor |
Research institution |
|
|
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 Sunil Surendraprasad Mishra |
Dr. D. Y. Patil Dental College and Hospital |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Dr. D. Y. Patil Dental College and Hospital, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA |
09890515247
aegisthesunil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biotene® Oral Balance Gel |
Standard application schedule |
| Intervention |
Jasmate® Mouthwash and Spray |
As per manufacturers instructions, applied daily for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults with clinically diagnosed burning mouth condition
VAS score 4–10
Able to give informed consent |
|
| ExclusionCriteria |
| Details |
Systemic diseases affecting saliva production
History of allergy to ingredients
Concurrent participation in another clinical trial |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in VAS score for burning mouth sensation
|
Day 1, Day 8, Day 15, Day 29
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OHIP-14 score changes
|
Day 1, Day 8, Day 15, Day 29 |
| Swallowing function (WST, EAT-10) |
Day 1, Day 8, Day 15, Day 29 |
| DryTraq test results |
Day 1, Day 8, Day 15, Day 29 |
| SWAL-QoL scores |
Day 1, Day 8, Day 15, Day 29 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This randomized clinical trial aims to compare the efficacy of Jasmate® Mouthwash and Spray with Biotene® Oral Balance Gel in patients with burning mouth syndrome associated with xerostomia. Forty participants will be randomly assigned to two groups. Evaluations will include VAS score for symptom relief, saliva flow rate, DryTraq™ lateral flow test, swallowing function (WST, EAT-10), and quality of life (OHIP-14, SWAL-QoL). The study is double-blinded, placebo-controlled, and conducted over one month with six-month follow-up for adverse effects. |